cholecalciferol and Osteoporosis--Postmenopausal

Osteoporosis is a major cause of morbidity and mortality worldwide and its prevention in order to avert fractures was considered of great importance in maintaining well-being and independence among the elderly. Strategies for osteoporosis prevention are well delineated, but research shows that the treatment options offered today could still be improved. The role of plain vitamin D (cholecalciferol) in bone health and the prevention of osteoporosis are well documented; however, as a treatment for osteoporosis, either with or without calcium, it has been shown to be ineffective. This is due in part to the strong negative feedback mechanisms in place in vitamin D-replete patients. However, other factors linked directly to ageing such as oestrogen depletion, reduced kidney or liver function may also be involved in reducing the body's capability to activate plain vitamin efficiently. This is why active vitamin D analogues such as alfacalcidol, 1-α-(OH)D3, are of clinical interest. Alfacalcidol requires only one hydroxylation reaction to become active 1,25-(OH)2-vitamin D3, and the 25-hydroxylase catalyzing this reaction is found in the liver and also interestingly in osteoblasts suggesting a local effect. Registered for use in postmenopausal osteoporosis, in most countries worldwide, alfacalcidol has also shown efficacy in glucocorticoid-induced and male osteoporosis. The present review provides compelling evidence for the efficacy of this compound in the treatment of osteoporosis and prevention of fractures both in monotherapy and when combined with other osteoporotic drugs where additive effects are clear. The safety profile of alfacalcidol is shown to be highly acceptable and it is considered less likely to induce hypercalcaemia than another more widely used analogue, calcitriol. Therefore, it remains unclear as to why alfacalcidol is not more widely used in clinical practice.

Topics: Aged; Cholecalciferol; Female; Humans; Male; Osteoporosis; Osteoporosis, Postmenopausal; Vitamin D; Vitamins

Middle East Respiratory Syndrome (MERS) is a novel respiratory illness firstly reported in Saudi Arabia in 2012. It is caused by a new corona virus, called MERS corona virus (MERS-CoV). Most people who have MERS-CoV infection developed severe acute respiratory illness.. This work is done to determine the clinical characteristics and the outcome of intensive care unit (ICU) admitted patients with confirmed MERS-CoV infection.. This study included 32 laboratory confirmed MERS corona virus infected patients who were admitted into ICU. It included 20 (62.50%) males and 12 (37.50%) females. The mean age was 43.99 ± 13.03 years. Diagnosis was done by real-time reverse transcription polymerase chain reaction (rRT-PCR) test for corona virus on throat swab, sputum, tracheal aspirate, or bronchoalveolar lavage specimens. Clinical characteristics, co-morbidities and outcome were reported for all subjects.. Most MERS corona patients present with fever, cough, dyspnea, sore throat, runny nose and sputum. The presence of abdominal symptoms may indicate bad prognosis. Prolonged duration of symptoms before patients' hospitalization, prolonged duration of mechanical ventilation and hospital stay, bilateral radiological pulmonary infiltrates, and hypoxemic respiratory failure were found to be strong predictors of mortality in such patients. Also, old age, current smoking, smoking severity, presence of associated co-morbidities like obesity, diabetes mellitus, chronic heart diseases, COPD, malignancy, renal failure, renal transplantation and liver cirrhosis are associated with a poor outcome of ICU admitted MERS corona virus infected patients.. Plasma HO-1, ferritin, p21, and NQO1 were all elevated at baseline in CKD participants. Plasma HO-1 and urine NQO1 levels each inversely correlated with eGFR (. SnPP can be safely administered and, after its injection, the resulting changes in plasma HO-1, NQO1, ferritin, and p21 concentrations can provide information as to antioxidant gene responsiveness/reserves in subjects with and without kidney disease.. A Study with RBT-1, in Healthy Volunteers and Subjects with Stage 3-4 Chronic Kidney Disease, NCT0363002 and NCT03893799.. HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).. 3 组患者手术时间、术中显性失血量及术后 1 周血红蛋白下降量比较差异均无统计学意义（. 对于肥胖和超重的膝关节单间室骨关节炎患者，采用 UKA 术后可获满意短中期疗效，远期疗效尚需进一步随访观察。.. Decreased muscle strength was identified at both time points in patients with hEDS/HSD. The evolution of most muscle strength parameters over time did not significantly differ between groups. Future studies should focus on the effectiveness of different types of muscle training strategies in hEDS/HSD patients.. These findings support previous adverse findings of e-cigarette exposure on neurodevelopment in a mouse model and provide substantial evidence of persistent adverse behavioral and neuroimmunological consequences to adult offspring following maternal e-cigarette exposure during pregnancy. https://doi.org/10.1289/EHP6067.. This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.. NCT04138212, date of registration: October 24, 2019.. Results of current investigation indicated that milk type and post fermentation cooling patterns had a pronounced effect on antioxidant characteristics, fatty acid profile, lipid oxidation and textural characteristics of yoghurt. Buffalo milk based yoghurt had more fat, protein, higher antioxidant capacity and vitamin content. Antioxidant and sensory characteristics of T. If milk is exposed to excessive amounts of light, Vitamins B. The two concentration of ZnO nanoparticles in the ambient air produced two different outcomes. The lower concentration resulted in significant increases in Zn content of the liver while the higher concentration significantly increased Zn in the lungs (p < 0.05). Additionally, at the lower concentration, Zn content was found to be lower in brain tissue (p < 0.05). Using TEM/EDX we detected ZnO nanoparticles inside the cells in the lungs, kidney and liver. Inhaling ZnO NP at the higher concentration increased the levels of mRNA of the following genes in the lungs: Mt2 (2.56 fold), Slc30a1 (1.52 fold) and Slc30a5 (2.34 fold). At the lower ZnO nanoparticle concentration, only Slc30a7 mRNA levels in the lungs were up (1.74 fold). Thus the two air concentrations of ZnO nanoparticles produced distinct effects on the expression of the Zn-homeostasis related genes.. Until adverse health effects of ZnO nanoparticles deposited in organs such as lungs are further investigated and/or ruled out, the exposure to ZnO nanoparticles in aerosols should be avoided or minimised.

Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor Proteins, Signal Transducing; Adenine; Adenocarcinoma; Adipogenesis; Administration, Cutaneous; Administration, Ophthalmic; Adolescent; Adsorption; Adult; Aeromonas hydrophila; Aerosols; Aged; Aged, 80 and over; Aging; Agriculture; Air Pollutants; Air Pollution; Airway Remodeling; Alanine Transaminase; Albuminuria; Aldehyde Dehydrogenase 1 Family; Algorithms; AlkB Homolog 2, Alpha-Ketoglutarate-Dependent Dioxygenase; Alzheimer Disease; Amino Acid Sequence; Ammonia; Ammonium Compounds; Anaerobiosis; Anesthetics, Dissociative; Anesthetics, Inhalation; Animals; Anti-Bacterial Agents; Anti-HIV Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Antibiotics, Antineoplastic; Antibodies, Antineutrophil Cytoplasmic; Antibodies, Monoclonal, Humanized; Antifungal Agents; Antigens, Bacterial; Antigens, CD; Antigens, Differentiation, Myelomonocytic; Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Antioxidants; Antitubercular Agents; Antiviral Agents; Apolipoproteins E; Apoptosis; Arabidopsis; Arabidopsis Proteins; Arsenic; Arthritis, Rheumatoid; Asthma; Atherosclerosis; ATP-Dependent Proteases; Attitude of Health Personnel; Australia; Austria; Autophagy; Axitinib; Bacteria; Bacterial Outer Membrane Proteins; Bacterial Proteins; Bacterial Toxins; Bacterial Typing Techniques; Bariatric Surgery; Base Composition; Bayes Theorem; Benzoxazoles; Benzylamines; beta Catenin; Betacoronavirus; Betula; Binding Sites; Biological Availability; Biological Oxygen Demand Analysis; Biomarkers; Biomarkers, Tumor; Biopsy; Bioreactors; Biosensing Techniques; Birth Weight; Blindness; Blood Chemical Analysis; Blood Gas Analysis; Blood Glucose; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Blood-Brain Barrier; Blotting, Western; Body Mass Index; Body Weight; Bone and Bones; Bone Density; Bone Resorption; Borates; Brain; Brain Infarction; Brain Injuries, Traumatic; Brain Neoplasms; Breakfast; Breast Milk Expression; Breast Neoplasms; Bronchi; Bronchoalveolar Lavage Fluid; Buffaloes; Cadherins; Calcification, Physiologic; Calcium Compounds; Calcium, Dietary; Cannula; Caprolactam; Carbon; Carbon Dioxide; Carboplatin; Carcinogenesis; Carcinoma, Ductal; Carcinoma, Ehrlich Tumor; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Carcinoma, Pancreatic Ductal; Carcinoma, Renal Cell; Cardiovascular Diseases; Carps; Carrageenan; Case-Control Studies; Catalysis; Catalytic Domain; Cattle; CD8-Positive T-Lymphocytes; Cell Adhesion; Cell Cycle Proteins; Cell Death; Cell Differentiation; Cell Line; Cell Line, Tumor; Cell Movement; Cell Nucleus; Cell Phone Use; Cell Proliferation; Cell Survival; Cell Transformation, Neoplastic; Cell Transformation, Viral; Cells, Cultured; Cellulose; Chemical Phenomena; Chemoradiotherapy; Child; Child Development; Child, Preschool; China; Chitosan; Chlorocebus aethiops; Cholecalciferol; Chromatography, Liquid; Circadian Clocks; 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Proto-Oncogene Proteins c-ret; Proto-Oncogene Proteins p21(ras); Proton Pumps; Protons; Protoporphyrins; Pseudomonas aeruginosa; Pseudomonas fluorescens; Pulmonary Artery; Pulmonary Disease, Chronic Obstructive; Pulmonary Gas Exchange; Pulmonary Veins; Pyrazoles; Pyridines; Pyrimidines; Qualitative Research; Quinoxalines; Rabbits; Random Allocation; Rats; Rats, Sprague-Dawley; Rats, Wistar; Receptors, Histamine H3; Receptors, Immunologic; Receptors, Transferrin; Recombinant Proteins; Recurrence; Reference Values; Referral and Consultation; Regional Blood Flow; Registries; Regulon; Renal Insufficiency, Chronic; Reperfusion Injury; Repressor Proteins; Reproducibility of Results; Republic of Korea; Research Design; Resistance Training; Respiration, Artificial; Respiratory Distress Syndrome; Respiratory Insufficiency; Resuscitation; Retinal Dehydrogenase; Retreatment; Retrospective Studies; Reverse Transcriptase Inhibitors; Rhinitis, Allergic; Ribosomal Proteins; Ribosomes; Risk Assessment; 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Topics: Absorptiometry, Photon; Bone Density; Bone Density Conservation Agents; Calcium; Cholecalciferol; Drug Therapy, Combination; Evidence-Based Medicine; Female; Humans; Life Style; Mass Screening; Osteoporosis, Postmenopausal; Patient Education as Topic; Physical Fitness; Risk Assessment; Risk Factors; Societies, Medical; United States; Women's Health

Although active vitamin D₃ only slightly increases bone mineral density (BMD) , it prevents fractures to a greater extent than is predicted, based on measurements of BMD. This effect is partly attributed to enhanced muscle strength and increased physical capabilities by vitamin D, which, in turn, decreases the risk of falls and fractures. In addition, active vitamin D₃ has been reported in animal studies to improve bone quality by enhancing trabecular bone microarchitecture and increasing enzymatic collagen cross-links in bone. A (large scale of) randomized controlled trial in Japanese postmenopausal women verified that the combination therapy of bisphosphonate (alendronate) plus active vitamin D₃ was more effective than monotherapy in terms of fracture prevention in high fracture risk group.

Topics: Animals; Bone and Bones; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Collagen; Diphosphonates; Drug Therapy, Combination; Female; Fractures, Bone; Fractures, Spontaneous; Humans; Osteoporosis, Postmenopausal; Risk

Topics: Bone Density; Bone Resorption; Calcitonin; Calcium; Cholecalciferol; Diphosphonates; Estradiol; Estrogens, Conjugated (USP); Female; Humans; Male; Osteoporosis; Osteoporosis, Postmenopausal; Progesterone; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators; Vitamin D

Recently, vitamin D metabolites have been internationally recognized to be effective for osteoporosis. The beneficial trend of the drugs for osteoporosis has been more in the prevention of fracture than in the increase of bone mineral density, and more in the prevention of fractures of four extremities compared to spinal fractures. The reason to reduce the fracture frequency of four extremities is due to increase the muscle power, the decrease of body sway and the reduction of falls by the action of the vitamin D. In the study of Japanese, it was declared that administration of active vitamin D significantly reduced the frequency of femoral neck fracture.

Topics: Accidental Falls; Aged; Aged, 80 and over; Cholecalciferol; Clinical Trials as Topic; Female; Femoral Neck Fractures; Humans; Middle Aged; Muscle Tonus; Muscle, Skeletal; Osteoporosis, Postmenopausal; Randomized Controlled Trials as Topic

Topics: Aged; Bone Density; Cholecalciferol; Clinical Trials as Topic; Drug Therapy, Combination; Estrogen Replacement Therapy; Estrogens; Female; Femur; Humans; Middle Aged; Osteoporosis, Postmenopausal; Spine

Topics: Bone Density; Cholecalciferol; Drug Therapy, Combination; Female; Humans; Osteoporosis, Postmenopausal; Randomized Controlled Trials as Topic; Vitamin K 2

The article entitled “Effects of Vitamin K2 on Osteoporosis, published in Curr Pharm Des 2004; 10(21): 2557-76, by Iwamoto\ J, Takeda T and Sato Y.” has been retracted by the Editorial office of the journal Current Pharmaceutical Design, as the text,\ data and some figures used/referred in this review article are from sources which have been retracted or under investigation on\ the basis of data fabrication and falsification, authorship misconduct, duplicate publication, unethical research practices, text\ recycling/self-plagiarism, and unresolved concerns about data integrity and research conduct. The authors were informed of\ this complaint and were requested to give justification on the matter in their defense. However, no reply was received from\ their side in this regard. Some sources that have been retracted are as follows:. 1. Iwamoto J, Takeda T, Ichimura S. Combined treatment with vitamin K2 and bisphosphonate in postmenopausal women with osteoporosis. Yonsei Med J 2003; 44: 751-6. Available at: https://eymj.org/DOIx.php?id=10.3349/ymj.2019.60.1.115.. 2. Sato Y, Honda Y, Kuno H, Oizumi K. Menatetrenone ameliorates osteopenia in disuse-affected limbs of vitamin D- and K-deficient stroke patients. Bone 1998; 23: 291-6. Available at: https://www.sciencedirect.com/science/article/pii/S8756328298001082.. 3. Sato Y, Honda Y, Kaji M, Asoh T, Hosokawa K, Kondo I, et al. Amelioration of osteoporosis by menatetrenone in elderly female\ Parkinson's disease patients with vitamin D deficiency. Bone 2002; 31: 114-8. Available at: https://pubmed.ncbi.nlm.nih.gov/\ 12110423/.. Bentham Science apologizes to its readers for any inconvenience this may have caused. The Bentham Editorial Policy on Article. Retraction can be found at https://benthamscience.com/editorial-policies-main.php. It is a condition of publication that manuscripts submitted to this journal have not been published and will not be simultaneously submitted or published elsewhere. Furthermore, any data, illustration, structure or table that has been published elsewhere must be reported, and copyright permission for reproduction must be obtained. Plagiarism is strictly forbidden, and by submitting the article for publication the authors agree that the publishers have the legal right to take appropriate action against the authors, if plagiarism or fabricated information is discovered. By submitting a manuscript, the authors agree that the copyright of their article is transferred to the publishers if and when the article is accepted for publication.

Topics: Animals; Calcium; Cholecalciferol; Drug Therapy, Combination; Female; Hip Fractures; Humans; Liver Diseases; Male; Osteocalcin; Osteoporosis; Osteoporosis, Postmenopausal; Space Flight; Vitamin K 2; Weightlessness

Topics: Age Factors; Bone Density; Calcitriol; Calcium; Calcium Channel Blockers; Cholecalciferol; Dietary Supplements; Drug Therapy, Combination; Estrogen Replacement Therapy; Female; Fractures, Bone; Humans; Osteoporosis; Osteoporosis, Postmenopausal; Randomized Controlled Trials as Topic; Selective Estrogen Receptor Modulators; Vitamin D Deficiency

Topics: Adult; Aged; Calcitonin; Cholecalciferol; Diphosphonates; Estrogen Replacement Therapy; Female; Fluorides; Humans; Male; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal

Hormonal control of skeletal growth, modeling, and remodeling is characterized by a complex interaction between the calciotropic hormones (25-hydroxycholecalciferol, 1,25-dihydroxycholecalciferol, parathyroid hormone, and calcitonin), growth, and thyroid hormones in addition to the estrogenic and androgenic gonadal hormones. Although both growth and thyroid hormones are essential skeletal growth and modeling and also can produce detrimental skeletal effects in adults when circulating in excess concentrations, these hormones assume a minor role in the day-to-day bone remodeling of the mature skeleton. Following the attainment of the peak bone mass, bone mineral content begins to decline in the fourth and fifth decades of life, accelerating in females in the first 5-7 years after the menopause as a result of estrogen deficiency. Associated with this age-dependent loss in skeletal mass are decreases in calcitonin reserve primarily in the 5-7 years following the menopause, decreases in circulating 25-hydroxycholecalciferol, intestinal resistance to 1,25-dihydroxycholecalciferol, and a gradual progressive rise in blood parathyroid hormone. These changes in calciotropic hormone profiles, together with poor nutritional habits, anticonvulsant, glucocorticoid, and thyroid medications, diseases such as type I diabetes, immobilization, or decreased physical activity all serve to weaken the aging skeleton. The result is a gradual and subtle change in skeletal anatomy, which progresses to alterations in vertebral structure, such as kyphosis, scoliosis, and pseudospondylolisthesis, and a variety of sciatic and nerve entrapment syndromes. Vertebral, forearm, and hip fractures and edentulism ultimately comprise the syndrome of age-related bone loss, resulting in lifestyle disabilities, extensive morbidity, analgesic drug abuse, hospitalization, and escalating annual health care expenditures.

Topics: Aging; Androgens; Calcifediol; Calcitonin; Cholecalciferol; Estrogens; Female; Growth Substances; Hormones; Humans; Osteoporosis; Osteoporosis, Postmenopausal; Thyroid Hormones

Elderly women and men lose bone at a rate of < or = 1% per year. This results in an increasing risk of most fractures, of which hip fractures account for the greatest proportion of death, disability, and medical costs. Falls are the immediate precipitating factor for about 90% of hip fractures and 80% of other types of fractures in women. Since the rate of bone remodeling increases with age, antiresorptive therapies are likely to be at least as effective in the elderly as in younger adults. Calcium supplementation, for example, slows bone loss more effectively in older women than in those within 5 years of menopause, although the effectiveness of calcium for prevention of fractures remains uncertain. Vitamin D deficiency is more common in the elderly, and supplementation of deficient women appears to slow bone loss, at least during winter. Calcium plus vitamin D may substantially reduce the risk of hip fracture in the frail elderly. A randomized trial showed that estrogen remains effective in preventing vertebral fractures in older women. There is no reason to believe that the effectiveness of other agents would diminish with age. Preventive therapy offers greatest and most immediate benefit to those who have the highest risk of fracture: the elderly, those with previous fractures, those at increased risk of falling, and those with lowest bone mass. Since the relationship between bone mass and risk of fracture remains strong in elderly women, bone mass measurements may also be as useful in the elderly as in younger adults.

Topics: Aged; Aged, 80 and over; Bone Density; Bone Remodeling; Calcium, Dietary; Cholecalciferol; Female; Fractures, Bone; Humans; Male; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal

To examine the effect of 25-hydroxyvitamin D (25(OH)D) levels recommended by Endocrine Society guidelines (>30 ng/mL) on cognition in healthy older African-American women over 3 years.. Randomized, double-blind, placebo-controlled clinical trial.. Bone Mineral Research Center at New York University Winthrop Hospital.. Healthy postmenopausal African American women aged 65 and older (N=260; mean age 68.2 ± 4.9; 46% college education or higher).. Half of the women were randomized to receive vitamin D (adjusted to achieve a serum level > 30 ng/mL) with calcium (diet and supplement total of 1,200 mg), and half were randomized to receive placebo with calcium (1,200 mg).. Cognitive assessments every 6 months using the Mini-Mental State Examination (MMSE) to detect cognitive decline. Mean MMSE scores were calculated over time for both groups. Those with MMSE scores less than 21 at baseline were excluded.. There was no difference in cognition over time between older African-American women with serum concentrations of 25(OH)D of 30 ng/mL and greater than those taking placebo. There is no evidence to support vitamin D intake greater than the recommended daily allowance in this population for preventing cognitive decline. J Am Geriatr Soc 67:81-86, 2019.

Topics: Aged; Aged, 80 and over; Black or African American; Cholecalciferol; Cognition; Cognitive Dysfunction; Dementia; Dietary Supplements; Double-Blind Method; Female; Healthy Volunteers; Humans; Osteoporosis, Postmenopausal; Physical Functional Performance; Postmenopause; Recommended Dietary Allowances; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Intestinal fractional calcium absorption (FCA) was assessed before and after vitamin D3 treatment. Serum 1,25(OH). To assess the effects of vitamin D3 compounds on intestinal FCA and calcium-regulating hormones in post-menopausal osteoporosis, a randomized open-label prospective study was conducted.. Forty eligible patients were allocated randomly into four groups: eldecalcitol (ELD; 0.75 μg/day), 1α hydroxyl calcidiol (ALF; 1 μg/day), plain vitamin D3 (800 IU/day), and control. Before and after the 4-week treatment, intestinal FCA was estimated by using a double isotope method, and serum concentrations of calcium-regulating hormones and a bone turnover marker were measured.. The baseline FCA value of the participants was 21.5 ± 7.9% (mean ± SD) and was significantly correlated with serum 1,25(OH). These findings suggest that oral administration of vitamin D3 analogues (ALF and ELD) stimulates FCA but plain vitamin D3 does not. Those effects of vitamin D3 compounds on FCA were independent of serum calcitriol concentration, suggesting that ALF and ELD may directly stimulate intestinal vitamin D receptors.

Topics: Administration, Oral; Aged; Bone Density Conservation Agents; Calcitriol; Calcium; Cholecalciferol; Female; Humans; Hydroxycholecalciferols; Intestinal Absorption; Osteoporosis, Postmenopausal; Prospective Studies; Vitamin D

Chinese PMO women (n = 219) were treated with 12-month ALN/D5600 (n = 111) or calcitriol (n = 108). Changes in 25(OH) D at month 12 were post hoc analyzed by the baseline 25 (OH) D status using the longitudinal analysis. The main safety outcome measures included serum calcium and phosphate and 24-h urine calcium, and the repeated measures mixed model was used to assess the frequencies of the calcium-phosphate metabolic disorders.. Absolute change in mean serum 25(OH) D level was the greatest in VD-deficient patients and least in VD-sufficient patients at months six and 12 (both, P < 0.01). Serum calcium level remained significantly lower in the ALN/D5600 treatment group than in the calcitriol treatment group throughout the 12 months. Mean 24-h urine calcium slightly increased in the ALN/D5600 treatment group and significantly increased in the calcitriol treatment group (+ 1.1 and + 0.9 mmol/L at months six and 12; both, P < 0.05). Calcitriol treatment was associated with more frequent hypercalciuria at month six (9.4% vs. 18.5%, P = 0.05), but not at month 12 (12.3% vs. 13.0%).. Baseline VD status predicted 25(OH) D improvement in PMO patients on 12-month ALN/D5600 treatment. The daily use of 0.25 μg of calcitriol was associated with more frequent hypercalciuria at month six, compared to ALN/5600 treatment, necessitating the safety re-evaluation of calcitriol at a higher dosage.

Topics: Aged; Aged, 80 and over; Alendronate; Biomarkers; Bone Density; Bone Density Conservation Agents; Calcifediol; Calcium Phosphates; China; Cholecalciferol; Female; Humans; Hypercalciuria; Middle Aged; Osteoporosis, Postmenopausal; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Baseline and on-treatment characteristics, including age, obesity, calcium intake, and bone turnover markers, may predict the bone mineral density (BMD) response in women with postmenopausal osteoporosis (PMO) to 1 to 2 years of antiresorptive therapy and/or vitamin D supplementation. This study aimed to explore clinical characteristics associated with 12-month BMD improvement in Chinese women with postmenopausal osteoporosis (PMO).In this post hoc analysis of a previous phase 3 multicenter, randomized controlled trial, Chinese PMO women who were treated with once weekly alendronate 70 mg/vitamin D3 5600 IU (ALN/D5600) or once daily calcitriol 0.25 mcg, and had measurements of 1-year lumbar spine BMD (LS-BMD) and on-treatment bone turnover markers (BTMs) were included in the analysis.In Chinese PMO patients on ALN/D5600, 1-year LS-BMD change was negatively correlated with age (β = -0.00084, P < .01), dietary calcium (β = -0.0017, P = .07), and procollagen type 1 N-terminal propeptide (P1NP) change at month 6 (β = -0.000469, P = .0016), but positively with body mass index (BMI) (β = 0.00128, P = .08); baseline P1NP above the median was associated with a significantly greater BMD percentage change at the lumbar spine (P = .02) and the total hip (P = .0001). In the calcitriol group, a significant 1-year LS-BMD increase was associated with BMI (β = 0.0023, P = .02), baseline P1NP (β = 0.00035, P = .0067), history of prior vertebral fracture(s) (β = 0.034, P < .0001) and baseline serum 25(OH)D level (β = -0.00083, P = .02).The presented findings from Chinese postmenopausal osteoporotic women suggested clinically meaningful baseline and on-treatment characteristics predicting BMD improvement after 1 year of ALN/D5600 treatment, which differed from calcitriol treatment with baseline identifiable associations. The study remained exploratory and further accumulation of evidence is needed.

Topics: Aged; Alendronate; Bone Density; Bone Density Conservation Agents; Calcitriol; China; Cholecalciferol; Dietary Supplements; Female; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Time Factors; Treatment Outcome

Evidence suggests that low vitamin D status may increase the risk of cancer.. To determine if dietary supplementation with vitamin D3 and calcium reduces the risk of cancer among older women.. A 4-year, double-blind, placebo-controlled, population-based randomized clinical trial in 31 rural counties (June 24, 2009, to August 26, 2015-the final date of follow-up). A total of 2303 healthy postmenopausal women 55 years or older were randomized, 1156 to the treatment group and 1147 to the placebo group. Duration of treatment was 4 years.. The treatment group (vitamin D3 + calcium group) received 2000 IU/d of vitamin D3 and 1500 mg/d of calcium; the placebo group received identical placebos.. The primary outcome was the incidence of all-type cancer (excluding nonmelanoma skin cancers), which was evaluated using Kaplan-Meier survival analysis and proportional hazards modeling.. Among 2303 randomized women (mean age, 65.2 years [SD, 7.0]; mean baseline serum 25-hydroxyvitamin D level, 32.8 ng/mL [SD, 10.5]), 2064 (90%) completed the study. At year 1, serum 25-hydroxyvitamin D levels were 43.9 ng/mL in the vitamin D3 + calcium group and 31.6 ng/mL in the placebo group. A new diagnosis of cancer was confirmed in 109 participants, 45 (3.89%) in the vitamin D3 + calcium group and 64 (5.58%) in the placebo group (difference, 1.69% [95% CI, -0.06% to 3.46%]; P = .06). Kaplan-Meier incidence over 4 years was 0.042 (95% CI, 0.032 to 0.056) in the vitamin D3 + calcium group and 0.060 (95% CI, 0.048 to 0.076) in the placebo group; P = .06. In unadjusted Cox proportional hazards regression, the hazard ratio was 0.70 (95% CI, 0.47 to 1.02). Adverse events potentially related to the study included renal calculi (16 participants in the vitamin D3 + calcium group and 10 in the placebo group), and elevated serum calcium levels (6 in the vitamin D3 + calcium group and 2 in the placebo group).. Among healthy postmenopausal older women with a mean baseline serum 25-hydroxyvitamin D level of 32.8 ng/mL, supplementation with vitamin D3 and calcium compared with placebo did not result in a significantly lower risk of all-type cancer at 4 years. Further research is necessary to assess the possible role of vitamin D in cancer prevention.. clinicaltrials.gov Identifier: NCT01052051.

Topics: Aged; Calcium; Cholecalciferol; Double-Blind Method; Female; Humans; Hypercalcemia; Incidence; Intention to Treat Analysis; Kaplan-Meier Estimate; Kidney Calculi; Middle Aged; Nebraska; Neoplasms; Osteoporosis, Postmenopausal; Proportional Hazards Models; Sample Size; Time Factors; Vitamin D; Vitamins

Vitamin D3 (cholecalciferol) dose required to maintain sufficiency in non- Caucasian women with postmenopausal osteoporosis (PMO) inthe tropics has not been well studied. Some guidelines mandate 800-1000 IU vitamin D/day but the Endocrine Society (US) advocates 1500-2000 IU/day to maintain 25-hydroxyvitamin-D (25(OH)D) concentration at >75 nmol/L. We aimed to establish oral cholecalciferol dose required to maintain 25(OH)D concentration at >75 nmol/L in PMO Chinese Malaysian women, postulating lower dose requirements amongst light-skinned subjects in the tropics.. 90 Chinese Malaysian PMO women in Kuala Lumpur, Malaysia (2°30'N) with baseline serum 25(OH)D levels >=50 nmol/L were recruited. Prior vitamin D supplements were discontinued and subjects randomized to oral cholecalciferol 25,000 IU/4-weekly (Group-A) or 50,000 IU/4-weekly (Group- B) for 16 weeks, administered under direct observation. Serum 25(OH)D, PTH, serum/urinary calcium were measured at baseline, 8 and 16 weeks.. Baseline characteristics, including osteoporosis severity, sun exposure (~3 hours/week), and serum 25(OH)D did not differ between treatment arms. After 16 weeks, 91% of women sufficient at baseline, remained sufficient on 25,000 IU/4-weekly compared with 97% on 50,000 IU/4-weekly with mean serum 25(OH)D 108.1±20.4 and 114.7±18.4 SD nmol/L respectively (p=0.273). At trial's end, 39% and 80% of insufficient women at baseline attained sufficiency in Group A and Group B (p=0.057). Neither dose was associated with hyperparathyroidism or toxicity.. Despite pretrial vitamin D supplementation and adequate sun exposure, 25.6% Chinese Malaysian PMO women were vitamin D insufficient indicating sunshine alone cannot ensure sufficiency in the tropics. Both ~900 IU/day and ~1800 IU/day cholecalciferol can safely maintain vitamin D sufficiency in >90% of Chinese Malaysian PMO women. Higher doses are required with baseline concentration <75 nmol/L.

Topics: Aged; Asian People; Calcium; China; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Malaysia; Middle Aged; Osteoporosis, Postmenopausal; Sunlight; Tropical Climate; Vitamin D; Vitamin D Deficiency

It has been hypothesized that high protein intakes are associated with lower bone mineral content (BMC). Previous studies yield conflicting results and thus far no studies have undertaken the interaction of body mass index (BMI) and physical activity with protein intakes in relation to BMC and bone mineral density (BMD).. To evaluate the associations of dietary total protein (TP), animal protein (AP) and plant protein (PP) intakes with BMC and BMD and their changes. We tested also the interactions of protein intake with, obesity (BMI ≤30 vs. >30 kg/m2) and physical activity level (passive vs. active). Design/ Setting: Prospective cohort study (Osteoporosis Risk-Factor and Fracture-Prevention Study). Participants/measures: At the baseline, 554 women aged 65-72 years filled out a 3-day food record and a questionnaire covering data on lifestyle, physical activity, diseases, and medications. Intervention group received calcium 1000 mg/d and cholecalciferol 800 IU for 3 years. Control group received neither supplementation nor placebo. Bone density was measured at baseline and year 3, using dual energy x-ray absorptiometry. Multivariable regression analyses were conducted to examine the associations between protein intake and BMD and BMC.. In cross-sectional analyses energy-adjusted TP (P≤0·029) and AP (P≤0·045) but not PP (g/d) were negatively associated with femoral neck (FN) BMD and BMC. Women with TP≥1·2 g/kg/body weight (BW) (Ptrend≤0·009) had lower FN, lumbar spine (LS) and total BMD and BMC. In follow-up analysis, TP (g/kg/BW) was inversely associated with LS BMD and LS BMC. The detrimental associations were stronger in women with BMI<30 kg/m2. In active women, TP (g/kg/BW) was positively associated with LS BMD and FN BMC changes.. This study suggests detrimental associations between protein intake and bone health. However, these negative associations maybe counteracted by BMI>30 kg/m2 and physical activity.

Topics: Absorptiometry, Photon; Aged; Aged, 80 and over; Animals; Body Mass Index; Bone and Bones; Bone Density; Calcium, Dietary; Cholecalciferol; Cross-Sectional Studies; Diet; Dietary Proteins; Dietary Supplements; Energy Intake; Exercise; Female; Fractures, Bone; Humans; Osteoporosis, Postmenopausal; Prospective Studies; Regression Analysis; Surveys and Questionnaires

The effects of higher than recommended vitamin D doses on bone mineral density (BMD) and quality are not known. In this study, higher intakes, in postmenopausal women undergoing weight control over 1 year, had no effect on areal or volumetric BMD but prevented the deterioration in cortical bone geometry.. Studies examining how bone responds to a standard dose of vitamin D supplementation have been inconsistent. In addition, the effects of higher doses on BMD and quality are not known. Postmenopausal women undergoing weight control to improve health outcomes are particularly at risk for bone loss and might benefit from supplemental vitamin D intake above the recommended allowance.. The decline in Ct thickness was prevented with higher vitamin D

Topics: Aged; Anthropometry; Body Composition; Body Weight; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Diet, Reducing; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Exercise; Female; Humans; Middle Aged; Obesity; Osteoporosis, Postmenopausal; Postmenopause; Weight Loss

Middle East Respiratory Syndrome (MERS) is a novel respiratory illness firstly reported in Saudi Arabia in 2012. It is caused by a new corona virus, called MERS corona virus (MERS-CoV). Most people who have MERS-CoV infection developed severe acute respiratory illness.. This work is done to determine the clinical characteristics and the outcome of intensive care unit (ICU) admitted patients with confirmed MERS-CoV infection.. This study included 32 laboratory confirmed MERS corona virus infected patients who were admitted into ICU. It included 20 (62.50%) males and 12 (37.50%) females. The mean age was 43.99 ± 13.03 years. Diagnosis was done by real-time reverse transcription polymerase chain reaction (rRT-PCR) test for corona virus on throat swab, sputum, tracheal aspirate, or bronchoalveolar lavage specimens. Clinical characteristics, co-morbidities and outcome were reported for all subjects.. Most MERS corona patients present with fever, cough, dyspnea, sore throat, runny nose and sputum. The presence of abdominal symptoms may indicate bad prognosis. Prolonged duration of symptoms before patients' hospitalization, prolonged duration of mechanical ventilation and hospital stay, bilateral radiological pulmonary infiltrates, and hypoxemic respiratory failure were found to be strong predictors of mortality in such patients. Also, old age, current smoking, smoking severity, presence of associated co-morbidities like obesity, diabetes mellitus, chronic heart diseases, COPD, malignancy, renal failure, renal transplantation and liver cirrhosis are associated with a poor outcome of ICU admitted MERS corona virus infected patients.. Plasma HO-1, ferritin, p21, and NQO1 were all elevated at baseline in CKD participants. Plasma HO-1 and urine NQO1 levels each inversely correlated with eGFR (. SnPP can be safely administered and, after its injection, the resulting changes in plasma HO-1, NQO1, ferritin, and p21 concentrations can provide information as to antioxidant gene responsiveness/reserves in subjects with and without kidney disease.. A Study with RBT-1, in Healthy Volunteers and Subjects with Stage 3-4 Chronic Kidney Disease, NCT0363002 and NCT03893799.. HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).. 3 组患者手术时间、术中显性失血量及术后 1 周血红蛋白下降量比较差异均无统计学意义（. 对于肥胖和超重的膝关节单间室骨关节炎患者，采用 UKA 术后可获满意短中期疗效，远期疗效尚需进一步随访观察。.. Decreased muscle strength was identified at both time points in patients with hEDS/HSD. The evolution of most muscle strength parameters over time did not significantly differ between groups. Future studies should focus on the effectiveness of different types of muscle training strategies in hEDS/HSD patients.. These findings support previous adverse findings of e-cigarette exposure on neurodevelopment in a mouse model and provide substantial evidence of persistent adverse behavioral and neuroimmunological consequences to adult offspring following maternal e-cigarette exposure during pregnancy. https://doi.org/10.1289/EHP6067.. This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.. NCT04138212, date of registration: October 24, 2019.. Results of current investigation indicated that milk type and post fermentation cooling patterns had a pronounced effect on antioxidant characteristics, fatty acid profile, lipid oxidation and textural characteristics of yoghurt. Buffalo milk based yoghurt had more fat, protein, higher antioxidant capacity and vitamin content. Antioxidant and sensory characteristics of T. If milk is exposed to excessive amounts of light, Vitamins B. The two concentration of ZnO nanoparticles in the ambient air produced two different outcomes. The lower concentration resulted in significant increases in Zn content of the liver while the higher concentration significantly increased Zn in the lungs (p < 0.05). Additionally, at the lower concentration, Zn content was found to be lower in brain tissue (p < 0.05). Using TEM/EDX we detected ZnO nanoparticles inside the cells in the lungs, kidney and liver. Inhaling ZnO NP at the higher concentration increased the levels of mRNA of the following genes in the lungs: Mt2 (2.56 fold), Slc30a1 (1.52 fold) and Slc30a5 (2.34 fold). At the lower ZnO nanoparticle concentration, only Slc30a7 mRNA levels in the lungs were up (1.74 fold). Thus the two air concentrations of ZnO nanoparticles produced distinct effects on the expression of the Zn-homeostasis related genes.. Until adverse health effects of ZnO nanoparticles deposited in organs such as lungs are further investigated and/or ruled out, the exposure to ZnO nanoparticles in aerosols should be avoided or minimised.

Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor Proteins, Signal Transducing; Adenine; Adenocarcinoma; Adipogenesis; Administration, Cutaneous; Administration, Ophthalmic; Adolescent; Adsorption; Adult; Aeromonas hydrophila; Aerosols; Aged; Aged, 80 and over; Aging; Agriculture; Air Pollutants; Air Pollution; Airway Remodeling; Alanine Transaminase; Albuminuria; Aldehyde Dehydrogenase 1 Family; Algorithms; AlkB Homolog 2, Alpha-Ketoglutarate-Dependent Dioxygenase; Alzheimer Disease; Amino Acid Sequence; Ammonia; Ammonium Compounds; Anaerobiosis; Anesthetics, Dissociative; Anesthetics, Inhalation; Animals; Anti-Bacterial Agents; Anti-HIV Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Antibiotics, Antineoplastic; Antibodies, Antineutrophil Cytoplasmic; Antibodies, Monoclonal, Humanized; Antifungal Agents; Antigens, Bacterial; Antigens, CD; Antigens, Differentiation, Myelomonocytic; Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Antioxidants; Antitubercular Agents; Antiviral Agents; Apolipoproteins E; Apoptosis; Arabidopsis; Arabidopsis Proteins; Arsenic; Arthritis, Rheumatoid; Asthma; Atherosclerosis; ATP-Dependent Proteases; Attitude of Health Personnel; Australia; Austria; Autophagy; Axitinib; Bacteria; Bacterial Outer Membrane Proteins; Bacterial Proteins; Bacterial Toxins; Bacterial Typing Techniques; Bariatric Surgery; Base Composition; Bayes Theorem; Benzoxazoles; Benzylamines; beta Catenin; Betacoronavirus; Betula; Binding Sites; Biological Availability; Biological Oxygen Demand Analysis; Biomarkers; Biomarkers, Tumor; Biopsy; Bioreactors; Biosensing Techniques; Birth Weight; Blindness; Blood Chemical Analysis; Blood Gas Analysis; Blood Glucose; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Blood-Brain Barrier; Blotting, Western; Body Mass Index; Body Weight; Bone and Bones; Bone Density; Bone Resorption; Borates; Brain; Brain Infarction; Brain Injuries, Traumatic; Brain Neoplasms; Breakfast; Breast Milk Expression; Breast Neoplasms; Bronchi; Bronchoalveolar Lavage Fluid; Buffaloes; Cadherins; Calcification, Physiologic; Calcium Compounds; Calcium, Dietary; Cannula; Caprolactam; Carbon; Carbon Dioxide; Carboplatin; Carcinogenesis; Carcinoma, Ductal; Carcinoma, Ehrlich Tumor; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Carcinoma, Pancreatic Ductal; Carcinoma, Renal Cell; Cardiovascular Diseases; Carps; Carrageenan; Case-Control Studies; Catalysis; Catalytic Domain; Cattle; CD8-Positive T-Lymphocytes; Cell Adhesion; Cell Cycle Proteins; Cell Death; Cell Differentiation; Cell Line; Cell Line, Tumor; Cell Movement; Cell Nucleus; Cell Phone Use; Cell Proliferation; Cell Survival; Cell Transformation, Neoplastic; Cell Transformation, Viral; Cells, Cultured; Cellulose; Chemical Phenomena; Chemoradiotherapy; Child; Child Development; Child, Preschool; China; Chitosan; Chlorocebus aethiops; Cholecalciferol; Chromatography, Liquid; Circadian Clocks; 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No data on the pharmacological treatment of normocalcemic hyperparathyroidism (NPHPT) are available. We treated 30 NPHPT postmenopausal women with alendronate/cholecalciferol (treated group) or vitamin D alone (control group). Over 1 year, bone mineral density (BMD) increased significantly in treated group, but not in control group. Both treatments did not affect serum or urinary calcium.. Normocalcemic primary hyperparathyroidism (NPHPT) is defined by normal serum calcium and consistently elevated PTH levels after ruling out the causes of secondary hyperparathyroidism. It is likely that subjects with NPHPT may develop kidney and bone disease. As no data on the pharmacological treatment of NPHPT are available, we aimed to investigate the effects of alendronate and cholecalciferol on both BMD and bone biochemical markers in postmenopausal women with NPHPT. Safety of vitamin D was evaluated as secondary endpoint.. The study was a prospective open label randomized trial comparing 15 postmenopausal women with NPHPT (PMW-NPHPT), treated with oral alendronate plus cholecalciferol (treated group) and 15 PMW-NPHPT treated only with cholecalciferol (control group). Blood samples were obtained at baseline and after 3, 6, and 12 months. Bone turnover markers (BTM) were measured at baseline, 3, and 6 months, respectively. BMD was assessed at baseline and after 12 months.. After 1 year of treatment, BMD increased significantly at the lumbar, femoral neck, and hip level in the treated group, but not in the control group (p = 0.001). No differences were found between or within groups in serum calcium, PTH, and urinary calcium levels. BTM significantly decreased in the treated group but not in the control group, at 3 and 6 months (p < 0.001), respectively. No cases of hypercalcemia or hypercalciuria were detected during the study.. The results of this study indicate that alendronate/cholecalciferol increases BMD in postmenopausal women with NPHPT. Alendronate/cholecalciferol or vitamin D alone does not affect serum or urinary calcium.

Topics: Administration, Oral; Alendronate; Bone Density; Bone Density Conservation Agents; Calcium; Cholecalciferol; Drug Combinations; Female; Femur; Humans; Hyperparathyroidism, Primary; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Prospective Studies

This study compares efficacy of ALN/D5600 versus that of calcitriol in osteoporotic Chinese postmenopausal women. ALN/D5600 produced greater bone mineral density (BMD) increases, greater bone turnover marker decreases, and less vitamin D insufficiency. This study provided detailed clinical information regarding ALN/D5600 treatment versus calcitriol 0.25 μg/day. The study did not evaluate fracture risk.. The aim of this study is to investigate efficacy of alendronate 70 mg/vitamin D3 5600 IU combination tablets (ALN/D5600) versus calcitriol in osteoporotic Chinese postmenopausal women.. This study is a 6-month, randomized, open-label, active-comparator study with 6-month extension (clinicaltrials.gov number NCT01350934) in postmenopausal women aged >55 years with osteoporosis (low bone mineral density (BMD) with/without prior fragility fracture). Patients were randomized to ALN/D5600 once weekly or calcitriol 0.25 μg daily. The primary efficacy end point of the base study was percent change from baseline in lumbar spine BMD (month 6). Hypercalcemia and hypercalciuria were safety events of special interest.. A total of 219 patients (ALN/D5600 n = 111, calcitriol n = 108) were randomized. Baseline characteristics were similar, 30.3 % baseline 25-hydroxyvitamin D (25(OH)D) ≤15 ng/mL. At months 6 and 12, changes in lumbar spine BMD from baseline were 3.5 versus 1.6 % and 5.2 versus 2.3 % for ALN/D5600 versus calcitriol (between-group differences p < 0.001), respectively. Between-group differences for ALN/D5600 versus calcitriol were significant (p < 0.001) at months 6 and 12 for change from baseline in procollagen type 1 N-terminal propeptide (-59.1 versus -16.8 %, -68.1 versus -17.0 %) and serum C-telopeptides (-79.2 versus -27.2 %, -76.2 versus -24.2 %). Drug-related adverse events (AEs) and discontinuations due to drug-related AEs occurred in 15 (14.0 %) versus 8 (7.4 %) patients and 3 (2.8 %) versus 0 patients in the ALN/D5600 and calcitriol group, respectively. Hypercalciuria 12-month incidence (24-h urine Ca >300 mg) was 8.4 (ALN/D5600) versus 13.9 % (calcitriol) (p > 0.05). One patient (calcitriol) had hypercalcemia.. ALN/D5600 produced greater increases in lumbar spine BMD and greater decreases in bone turnover markers versus calcitriol in osteoporotic Chinese women. It is not known whether the greater increase in BMD results in fewer fractures. ALN/D5600 was generally well tolerated in Chinese patients.

Topics: Aged; Alendronate; Biomarkers; Bone Density Conservation Agents; Bone Remodeling; Calcitriol; Cholecalciferol; Drug Combinations; Female; Femur Neck; Hip Joint; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Tablets; Vitamin D

Ensuring adequate vitamin D status in older adults may reduce the risk of osteoporosis. The serum 25-hydroxyvitamin D [25(OH)D] concentration is the recommended biomarker of vitamin D status, but the optimal serum 25(OH)D concentration for bone health in postmenopausal women remains unclear.. The aim of this study was to apply the highly sensitive (41)Ca skeletal labeling technique and the measurement of urinary (41)Ca:(40)Ca ratios to determine the serum 25(OH)D concentration that has greatest benefit on bone calcium flux in postmenopausal women.. We administered a mean intravenous (41)Ca dose of 870 pmol to healthy postmenopausal women [n = 24, age (mean ± SD): 64 ± 6.0 y] without osteoporosis. After 6 mo, at the nadir of their wintertime serum 25(OH)D status, each of the women sequentially consumed daily oral cholecalciferol supplements of 10, 25, and 50 μg/d (in this order), each for 3 mo. We assessed serum 25(OH)D concentrations monthly and urinary (41)Ca:(40)Ca ratios biweekly. (41)Ca:(40)Ca ratios were measured with low-energy accelerator mass spectrometry. With the use of pharmacokinetic analysis, we determined the effect of varying serum 25(OH)D concentrations on (41)Ca transfer rates.. At baseline, the mean (95% CI) serum 25(OH)D concentration was 16.2 (13.5, 18.8) μg/L. After the first, second, and third intervention periods, mean (95% CI) serum 25(OH)D increased to 29.8 (27.2, 32.4), 36.9 (34.2, 39.7), and 46.6 (41.2, 52.0) μg/L, respectively. Supplementation was associated with a downward shift in the urinary (41)Ca:(40)Ca ratio compared with the predicted (41)Ca:(40)Ca ratio without vitamin D supplementation. In the model, the most likely site of action of the increase in serum 25(OH)D was transfer from the central compartment to a fast exchanging compartment. At this transfer rate, predicted values were a concentration with half-maximal effect of 2.33 μg/L and an estimate of the maximal effect of 31.7%. After the first, second, and third intervention periods, the mean changes in this transfer rate were +18.0%, +25.7%, and +28.5%, respectively.. In healthy postmenopausal women, increasing serum 25(OH)D primarily affects calcium transfer from the central compartment to a fast exchanging compartment; it is possible that this represents transfer from the extracellular space to the surface of bone. A serum 25(OH)D concentration of ~40 μg/L achieves ~90% of the expected maximal effect on this transfer rate. This trial was registered at clinicaltrials.gov as NCT01053481.

Topics: 25-Hydroxyvitamin D 2; Aged; Biomarkers; Bone Density Conservation Agents; Bone Remodeling; Calcifediol; Calcium; Calcium Radioisotopes; Cholecalciferol; Cohort Studies; Dietary Supplements; Down-Regulation; Female; Humans; Kinetics; Middle Aged; Osteoporosis, Postmenopausal; Risk Factors; Seasons; Switzerland

This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2  g/vitamin D₃ 1000  IU daily vs strontium ranelate 2  g daily for correcting vitamin D insufficiency in osteoporosis.. A 6-month international, randomized, double-blind, parallel-group, phase 3 study.. A total of 518 men and postmenopausal women aged ≥50 years with primary osteoporosis (T-score ≤-2.5 s.d.) and serum 25-hydroxyvitamin D (25(OH)D) >22.5 nmol/l were included. Patients were allocated to strontium ranelate 2 g/vitamin D₃ 1000  IU daily (n=413) or strontium ranelate 2 g daily (n=105). The participants received calcium 1 g daily. The primary endpoint was serum 25(OH)D at last post-baseline evaluation during 3 months.. Both groups were comparable at baseline. Mean baseline of 25(OH)D was 44.1 ± 14.6 nmol/l. After 3 months, the percentage of patients with 25(OH)D ≥50 nmol/l was higher with strontium ranelate/vitamin D₃ vs strontium ranelate (84 vs 44%, P<0.001; adjusted between-group odds ratio=6.7; 95% CI, 4.2-10.9). The efficacy of the fixed-dose combination on 25(OH)D was maintained at 6 months (86 vs 40%, P<0.001). Mean 25(OH)D was 65.1 and 49.5 nmol/l, respectively, after 3 months and 66.9 and 45.4 nmol/l after 6 months. Physical performance improved in both groups. Falls were 17 and 20% in the strontium ranelate/vitamin D₃ and strontium ranelate groups respectively. Parathyroid hormone levels were inversely correlated with 25(OH)D. No clinically relevant differences in safety were observed.. This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D₃ 1000 IU for correction of vitamin D insufficiency in osteoporotic patients.

Topics: Aged; Cholecalciferol; Female; Humans; Male; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal; Strontium; Thiophenes; Vitamin D; Vitamin D Deficiency

The maximal calcium absorption in response to vitamin D has been proposed as a biomarker for vitamin D sufficiency.. The objective was to determine whether there is a threshold beyond which increasing doses of vitamin D, or concentrations of serum 25-hydroxyvitamin D [25(OH)D], no longer increase calcium absorption.. This was a placebo-controlled, dose-response, randomized, double-blind study of the effect of vitamin D on calcium absorption in healthy postmenopausal women. Seventy-six healthy postmenopausal women were randomly assigned to placebo or 800 IU (20 μg), 2000 IU (50 μg), or 4000 IU (100 μg) vitamin D₃ for 8 wk. The technique of dual isotopes of stable calcium was used with a calcium carrier to measure calcium absorption at baseline and after 8 wk.. Seventy-one women with a mean ± SD age of 58.8 ± 4.9 y completed the study. The mean calcium intake was 1142 ± 509 mg/d and serum 25(OH)D was 63 ± 14 nmol/L at baseline. A statistically significant linear trend of an increase in calcium absorption adjusted for age and body mass index with increasing vitamin D₃ dose or serum 25(OH)D concentration was observed. A 6.7% absolute increase in calcium absorption was found in the highest vitamin D₃ group (100 μg). No evidence of nonlinearity was observed in the dose-response curve.. No evidence of a threshold of calcium absorption was found with a serum 25(OH)D range from 40 to 130 nmol/L. Calcium absorption in this range is not a useful biomarker to determine nutritional recommendations for vitamin D.

Topics: Biomarkers; Bone Density Conservation Agents; Calcifediol; Calcium; Calcium Isotopes; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Follow-Up Studies; Humans; Intestinal Absorption; Middle Aged; New York; Nutritional Requirements; Osteoporosis, Postmenopausal; Postmenopause; Seasons; Vitamin D Deficiency

Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D₃ (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients.

Topics: Adult; Aged; Alendronate; Cholecalciferol; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Vitamin D Deficiency

Denosumab is a new potent antiresorptive treatment of osteoporosis that can potentially induce a compensatory increase in parathyroid hormone (PTH) levels. We aimed to evaluate the alteration of PTH 1 and 6 months after denosumab's administration with different regimens of calcium and vitamin D (Ca/D) supplementation.. Prospective, multicenter, study in a relatively small, heterogeneous sample of postmenopausal women followed for 6 months.. Forty seven postmenopausal women followed in 2 outpatient clinics, requiring onset or continuation of osteoporosis treatment. We administered 1 g calcium carbonate and 800 IU cholecalciferol daily for 6 months (Group A) or the double dose for the first month followed by the 1 g/800 IU Ca/D regimen for the next 5 months (Group B).. Parathyroid hormone (PTH) alterations between and within groups, and their associations with serum Ca and bone markers.. Parathyroid hormone (PTH) levels were significantly higher at month 1 and 6 only in Group A; Ca levels were significantly decreased at month 1 and returned to baseline values at month 6 within the same Group. The mean per cent change between month 1 and baseline for PTH [Δ(PTH1-0 )] was significantly higher in Group A than B (63·5% ± 28·2% vs -3·0% ± 4·7%, P = 0·029). Δ(PTH1-0 ) was correlated with the reciprocal Δ-changes of Ca (rs  = -0·610; P = 0·002) and collagen type I C-terminal telopeptide (rs  = -0·697; P = 0·003) only in Group A.. An increase in PTH should be expected, at least following the first administration of denosumab in common clinical practice. The effect of this compensatory onsequence in bone metabolism warrants further investigation.

Topics: Aged; Antibodies, Monoclonal, Humanized; Bone Density; Calcium; Calcium Carbonate; Cholecalciferol; Denosumab; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Parathyroid Hormone; Prospective Studies; Time Factors; Treatment Outcome; Vitamins

Recent research results have confirmed the high significance of the OPG/RANK/RANKL system in the development of bone diseases.. The aim of the reported study was to assess gene expression levels of the OPG/RANK/RANKL system in peripheral blood mononuclear cells (PBMCs) after strontium ranelate (SR) and ibandronate administered to patients with postmenopausal osteoporosis.. A total of 89 postmenopausal women, aged 51 to 85 years, patients of the Outpatient Clinic of Osteoporosis of the Military Teaching Hospital in Lodz, were enrolled into the study. The patients were randomly assigned to different medical therapies: ibandronate and SR. Patients of the control group received only calcium and vitamin D₃ supplements. Patient visits were repeated after 3 and 6 months. Measurements of serum alkaline phosphatase concentrations and of RNA expression in PBMCs as well as of total serum calcium and phosphate levels and of their 24-hour urine excretion rates were carried out in material, collected at baseline and after 3 and 6 months of the therapy. Densitometry of the left hip and of the lumbar spine was done at the baseline visit and after 6 months.. The differences in gene expressions of RANKL and RANK were not significant during the study period and did not differ between the groups in a statistically significant manner. No OPG gene expression was observed in PBMCs of patients in any of the studied groups and at any time point. The tendency of correlation (P = .07) was observed between decreasing RANK gene expression and increasing bone mineral density in the patients treated with SR.. Both ibandronate and SR do not seem to cause any significant changes in gene expression levels of OPG/RANK/RANKL in PBMCs during the first 6 months of treatment.

Topics: Aged; Aged, 80 and over; Bone Density; Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Combined Modality Therapy; Dietary Supplements; Diphosphonates; Female; Gene Expression Regulation; Humans; Ibandronic Acid; Leukocytes, Mononuclear; Middle Aged; Organometallic Compounds; Osteoporosis, Postmenopausal; Osteoprotegerin; RANK Ligand; Receptor Activator of Nuclear Factor-kappa B; RNA, Messenger; Thiophenes

Sclerostin is a circulating inhibitor of the Wnt-signaling pathway produced by osteocytes, which acts as a negative regulator of bone formation. Effects of zoledronic acid on sclerostin serum levels in postmenopausal osteoporosis are unknown.. The purpose of this study was to evaluate sclerostin serum levels after zoledronic acid administration and correlate variations with bone turnover markers.. We conducted a prospective intervention study in an ambulatory care setting.. Forty women (mean age 62.6 ± 4.9 years) with postmenopausal osteoporosis were enrolled in this study and randomized into 2 groups to receive zoledronic acid (5 mg) or placebo.. At baseline and then at 2, 7, 30, and 360 days after zoledronic acid or placebo administration, serum levels of sclerostin, bone-specific alkaline phosphatase (BSAP), as a bone formation marker, and serum C-telopeptide of type 1 collagen (CTX), as a bone resorption marker, were measured.. Sclerostin serum levels increased by day 2, reached a peak at day 7 (3-fold baseline, P < .001), and then decreased at day 30 and returned near to baseline after 360 days in the zoledronic acid group. Both CTX and BSAP were reduced, and a significant negative correlation was observed between the percentage changes of sclerostin and the variation in BSAP and CTX at all time points in the zoledronic acid group (P < .05). No changes were observed in the placebo group.. Our data demonstrate that zoledronic acid increases sclerostin serum levels and that sclerostin could play a role in coupling bone resorption to bone formation.

Topics: Adaptor Proteins, Signal Transducing; Aged; Biomarkers; Bone and Bones; Bone Density Conservation Agents; Bone Morphogenetic Proteins; Bone Regeneration; Bone Resorption; Calcium Carbonate; Cholecalciferol; Collagen Type I; Combined Modality Therapy; Dietary Supplements; Diphosphonates; Female; Genetic Markers; Humans; Imidazoles; Infusions, Intravenous; Middle Aged; Osteoporosis, Postmenopausal; PAX5 Transcription Factor; Peptides; Time Factors; Zoledronic Acid

Nutritional prevention of bone deterioration with fortified foods seems particularly suitable in institutionalized elderly women at risk of vitamin D deficiency, secondary hyperparathyroidism, increased bone resorption, and osteoporotic fracture.. The objective was to evaluate whether fortification of yogurts with vitamin D and calcium exerts an additional lowering effect on serum PTH and bone resorption markers as compared with isocaloric and isoprotein dairy products in elderly women.. A randomized double-blind controlled-trial, 56-day intervention was conducted in institutionalized women (mean age 85.5 years) consuming 2 125-g servings of either vitamin D- and calcium-fortified yogurt (FY) at supplemental levels of 10 μg/d vitamin D₃ and 800 mg/d calcium or nonfortified control yogurt (CY) providing 280 mg/d calcium.. The endpoints were serum changes from baseline (day 0) to day 28 and day 56 in 25-hydroxyvitamin-D (25OHD), PTH, and bone resorption markers tartrate-resistant acid phosphatase isoform-5b (TRAP5b), the primary outcome, and carboxyl-terminal cross-linked telopeptide of type I collagen (CTX).. At day 56, serum 25OHD increased (mean ± SEM) by 25.3 ± 1.8 vs 5.2 ± 2.5 nmol/L in FY (n = 29) and CY (n = 27), respectively (P < .0001). The corresponding changes in PTH were -28.6% ± 7.2% vs -8.0% ± 4.3% (P = .0003); in TRAP5b, -21.9% ± 4.3% vs 3.0% ± 3.2% (P < .0001); and in CTX, -11.0% ± 9.7% vs -3.0% ± 4.1% (P = .0146), in FY and CY, respectively. At day 28, these differences were less pronounced but already significant for 25OHD, PTH, and TRAP5b.. This study in institutionalized elderly at high risk for osteoporotic fracture suggests that fortification of dairy products with vitamin D₃ and calcium provides a greater prevention of accelerated bone resorption as compared with nonfortified equivalent foods.

Topics: Acid Phosphatase; Aged, 80 and over; Biomarkers; Bone Density Conservation Agents; Bone Resorption; Calcium, Dietary; Cholecalciferol; Collagen Type I; Double-Blind Method; Female; Food, Fortified; France; Homes for the Aged; Humans; Hyperparathyroidism, Secondary; Isoenzymes; Nursing Homes; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Parathyroid Hormone; Peptides; Risk; Tartrate-Resistant Acid Phosphatase; Vitamin D Deficiency; Yogurt

This study investigated the efficacy and safety of monthly risedronate, with and without cholecalciferol, on 25-hydroxyvitamin D (25[OH]D) levels and bone markers in Korean patients with osteoporosis.. A randomized, double-blinded, prospective, 16-week clinical trial was conducted in ten hospitals. A total of 150 subjects with osteoporosis were randomized to one of the two treatment groups: RSDM+ (monthly risedronate 150 mg and cholecalciferol 30,000 IU combined in a single pill, n = 74) or RSDM (monthly risedronate 150 mg alone, n = 76). We measured serum levels of 25-hydroxyvitamin D (25[OH]D), parathyroid hormone (PTH), and bone markers, as well as performing muscle-function tests at baseline and after 16 weeks of treatment.. After 16 weeks, serum 25(OH)D levels significantly increased from 17.8 to 26.8 ng/mL in the RSDM+ group, but did not change in the RSDM group. The RSDM+ group exhibited significantly decreased serum PTH from 46 to 36.7 pg/mL, while the RSDM group showed a tendency for PTH to increase from 38 to 40.6 pg/mL. In both groups, serum bone-specific alkaline phosphatase and C-terminal telopeptide rapidly declined, with significance at 16 weeks; there were no significant differences between the groups.. A once-monthly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D levels over the 16-week treatment period without significant adverse events in Korean patients with osteoporosis.

Topics: Absorptiometry, Photon; Aged; Alkaline Phosphatase; Biomarkers; Bone Density Conservation Agents; Chi-Square Distribution; Cholecalciferol; Collagen Type I; Double-Blind Method; Drug Combinations; Etidronic Acid; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Peptides; Prospective Studies; Republic of Korea; Risedronic Acid; Treatment Outcome; Vitamin D

Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis.. The effects of ODN were evaluated on bone mineral density (BMD), biochemical markers of bone turnover, and safety in patients previously treated with alendronate.. This was a randomized, double-blind, placebo-controlled, 24-month study.. The study was conducted at private or institutional practices.. Postmenopausal women (n = 243) ≥ 60 years of age with low BMD at the total hip, femoral neck, or trochanter (T-score ≤-2.5 but >-3.5 without prior fracture or ≤-1.5 but >-3.5 with prior fracture) on alendronate for ≥ 3 years.. The intervention included ODN 50 mg or placebo weekly.. The primary end point was percentage change from baseline of femoral neck BMD at month 24. BMD was assessed by dual-energy x-ray absorptiometry at baseline and 6, 12, and 24 months. Biochemical markers of bone turnover (serum C-telopeptides of type 1 collagen, urinary N-telopeptides of type 1 collagen, serum bone specific alkaline phosphatase, and serum N-terminal propeptide of type 1 collagen) were measured at baseline and 3, 6, 12, 18, and 24 months.. In the ODN group, BMD changes from baseline at the femoral neck, trochanter, total hip, and lumbar spine at 24 months (1.7%, 1.8%, 0.8%, and 2.3%, respectively) were significantly different from the placebo group. ODN significantly decreased urinary N-telopeptides of type 1 collagen to creatinine ratio and significantly increased serum N-terminal propeptide of type 1 collagen compared with placebo. Serum C-telopeptides of type 1 collagen was unexpectedly increased with ODN treatment. The safety profile appeared similar between groups.. ODN provided incremental BMD gains in osteoporotic women after alendronate treatment.

Topics: Aged; Alendronate; Biomarkers; Biphenyl Compounds; Bone and Bones; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Calcium, Dietary; Cathepsin K; Cholecalciferol; Combined Modality Therapy; Dietary Supplements; Double-Blind Method; Drug Monitoring; Female; Humans; Medication Adherence; Middle Aged; Osteoporosis, Postmenopausal; Patient Dropouts; Protease Inhibitors

Many postmenopausal women desire non-pharmaceutical alternatives to hormone therapy for protection against osteoporosis. Soybean isoflavones, especially genistein, are being studied for this purpose. This study examined the effects of synthetic genistein in combination with other potential bone-protective dietary molecules on bone mineral density (BMD) in early postmenopausal women.. In this 6-month double-blind pilot study, 70 subjects were randomized to receive daily either calcium only or the geniVida™ bone blend (GBB), which consisted of genistein (30 mg/days), vitamin D3 (800 IU/days), vitamin K1 (150 μg/days) and polyunsaturated fatty acids (1 g polyunsaturated fatty acids as ethyl ester: eicosapentaenoic acid/docosahexaenoic acid ratio = ~2/1). Markers of bone resorption and formation and BMD at the femoral neck, lumbar spine, Ward's triangle, trochanter and intertrochanter, total hip and whole body were assessed.. Subjects supplemented with the GBB (n = 30) maintained femoral neck BMD, whereas in the placebo group (n = 28), BMD significantly decreased (p = 0.007). There was also a significant difference (p < 0.05) in BMD between the groups at Ward's triangle in favor of the GBB group. Bone-specific alkaline phosphatase and N-telopeptide significantly increased in the GBB group in comparison with those in baseline and in the placebo group. The GBB was well tolerated, and there were no significant differences in adverse events between groups.. The GBB may help to prevent osteoporosis and reduce fracture risk, at least at the hip, in postmenopausal women. Larger and longer-term clinical trials are warranted.

Topics: Bone Density; Bone Resorption; Calcium, Dietary; Cholecalciferol; Double-Blind Method; Fatty Acids, Unsaturated; Female; Femur; Femur Neck; Genistein; Humans; Lumbar Vertebrae; Middle Aged; Motor Activity; Osteoporosis, Postmenopausal; Patient Compliance; Pilot Projects; Vitamin K 1; Vitamins

The aim of this study was to investigate the additive effect of the active form of vitamin D3 on the gain in back extensor strength through a back extensor exercise.. A total of 107 postmenopausal women with osteoporosis were randomly divided into two groups: the D3 group and the control group. Both groups were treated with calcium and alendronate and undertook the back extensor exercise. Alfacalcidol was prescribed only to the D3 group.. There was no significant difference in the demographic data between the two groups. Ninety-four participants who completed a 4-mo intervention were subjected to per-protocol analysis. There was no significant difference in the improvement in back extensor strength between two the groups (P = 0.349). All subjects were further categorized into two subgroups by age. In the older subgroup (≥68 yrs), no significant difference was found in the improvement in back extensor strength (P = 0.316). In the younger subgroup (<68 yrs), the back extensor strength in the D3 group was significantly more improved than in the control group (P = 0.034).. The results of this study suggest that the administration of the active form of vitamin D3 enhances the beneficial effects of the back extensor exercise in patients younger than those in their late 60s.

Topics: Age Factors; Aged; Back; Bone Density Conservation Agents; Cholecalciferol; Collagen Type I; Exercise; Female; Humans; Hydroxycholecalciferols; Middle Aged; Movement; Muscle Strength; Osteoporosis, Postmenopausal; Peptides; Prospective Studies; Quality of Life

The use of aromatase inhibitor (AI) in postmenopausal women with hormone receptor (HR)-positive early breast cancer (EBC) produces a deleterious effect on bone mass and an increase in fractures. Several studies using intravenous bisphosphonates have shown effective management of AI-induced bone loss. To determine whether a lower dosage in oral form combined with calcitriol can effectively manage AI-induced bone loss, we performed a randomized, double-blind, prospective, placebo-controlled 24-week trial with a combination of alendronate and 0.5-µg of calcitriol daily to HR-positive EBC patients. A total of 98 Korean postmenopausal women with HR-positive EBC who received daily AI, calcium and vitamin D were randomly assigned to 5-mg of alendronate and 0.5-µg of calcitriol (Maxmarvil®) or placebo groups. The bone mineral density (BMD) and turnover markers were measured. At week 24, the difference in lumbar BMD between the groups was 3.0% (p < 0.005). The increase in C-telopeptide after 24 weeks was significantly less in the Maxmarvil group compared to that in the placebo group (35.2 ± 17.5% vs. 109.8 ± 28.6%, p < 0.05). Our study demonstrates that a combination of 5-mg alendronate and 0.5-µg calcitriol is effective to prevent bone loss due to AI in Korean postmenopausal women with EBC.

Topics: Alendronate; Antineoplastic Agents; Aromatase Inhibitors; Biomarkers; Bone and Bones; Bone Density; Bone Density Conservation Agents; Bone Resorption; Breast Neoplasms; Calcitriol; Calcium, Dietary; Cholecalciferol; Collagen Type I; Combined Modality Therapy; Dietary Supplements; Double-Blind Method; Drug Combinations; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Patient Dropouts; Peptides; Postmenopause; Republic of Korea

The Women's Health Initiative (WHI) double-blind, placebo-controlled clinical trial randomly assigned 36,282 postmenopausal women in the U.S. to 1,000 mg elemental calcium carbonate plus 400 IU of vitamin D(3) daily or placebo, with average intervention period of 7.0 years. The trial was designed to test whether calcium plus vitamin D supplementation in a population in which the use of these supplements was widespread would reduce hip fracture, and secondarily, total fracture and colorectal cancer.. This study further examines the health benefits and risks of calcium and vitamin D supplementation using WHI data, with emphasis on fractures, cardiovascular disease, cancer, and total mortality.. WHI calcium and vitamin D randomized clinical trial (CT) data through the end of the intervention period were further analyzed with emphasis on treatment effects in relation to duration of supplementation, and these data were contrasted and combined with corresponding data from the WHI prospective observational study (OS).. Among women not taking personal calcium or vitamin D supplements at baseline, the hazard ratio [HR] for hip fracture occurrence in the CT following 5 or more years of calcium and vitamin D supplementation versus placebo was 0.62 (95 % confidence interval (CI), 0.38-1.00). In combined analyses of CT and OS data, the corresponding HR was 0.65 (95 % CI, 0.44-0.98). Supplementation effects were not apparent on the risks of myocardial infarction, coronary heart disease, total heart disease, stroke, overall cardiovascular disease, colorectal cancer, or total mortality, while evidence for a reduction in breast cancer risk and total invasive cancer risk among calcium plus vitamin D users was only suggestive.. Though based primarily on a subset analysis, long-term use of calcium and vitamin D appears to confer a reduction that may be substantial in the risk of hip fracture among postmenopausal women. Other health benefits and risks of supplementation at doses considered, including an elevation in urinary tract stone formation, appear to be modest and approximately balanced.

Topics: Aged; Bone Density Conservation Agents; Calcium Carbonate; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Hip Fractures; Humans; Middle Aged; Neoplasms; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Risk Assessment; United States; Urinary Calculi

Vitamin D is widely used in osteoporosis treatment, although the optimal dose is not known. This 1-year clinical study among 297 women aged 50-80 years old showed that a vitamin D(3) dose of 6,500 IU/day was not better than the standard dose of 800 IU/day in improving bone mineral density (BMD) in the hip and spine.. The purpose of this study was to determine whether a high dose of vitamin D(3) was better than the standard dose in improving BMD and reducing bone turnover in postmenopausal women with reduced bone mass.. The study was a 1-year randomized double-blind controlled trial comparing high-dose vitamin D(3) with the standard dose. Postmenopausal women (n = 297) with a BMD T-score ≤ -2.0 in either lumbar spine (L2-4) or total hip were included and randomized to 6,500 IU vitamin D(3)/day (20,000 IU twice per week + 800 IU/day) or 800 IU vitamin D(3)/day (placebo twice per week + 800 IU/day). Both groups were given 1,000 mg elemental calcium/day. The primary endpoint was a change in BMD in total hip and lumbar spine (L2-4).. After 1 year, serum 25-hydroxyvitamin D (25(OH)D) increased [mean (SD)] from 71 (23) to 185 (34) nmol/l and from 71 (22) to 89 (17) nmol/l in the high- and standard-dose vitamin D groups, respectively. BMD at all measurement sites was unchanged or slightly improved with no significant differences between the groups. Although bone turnover was reduced in both groups, the more pronounced reduction in serum levels of the bone formation marker P1NP in the standard-dose group may indicate that this treatment was more efficient. Adverse events did not differ between the groups.. One year treatment with 6,500 IU vitamin D(3)/day was not better than 800 IU/day regarding BMD in vitamin D-replete postmenopausal women with reduced bone mass and was less efficient in reducing bone turnover.

Topics: Aged; Aged, 80 and over; Bone Density; Bone Remodeling; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Hip Joint; Humans; Lumbar Vertebrae; Medication Adherence; Middle Aged; Motor Activity; Osteoporosis, Postmenopausal; Vitamin D

The objective of this study was to determine the safety and efficacy of long-term minodronate treatment in women with postmenopausal osteoporosis based on re-analysis of a phase III 2-year clinical trial with a 1-year extension. Women aged 55-80 years old with fragility fractures were enrolled and randomized to take 1 mg minodronate or placebo once a day in the original 2-year study. The subjects who completed the 2-year study were invited to participate in an additional 1-year extension in which all subjects were to receive minodronate. Finally, a total 380 subjects completed the extension study (186 from the placebo group and 194 from the minodronate group). Fracture results observed in the extension study were consistent with those observed in the first 2 years in minodronate group. In contrast, the placebo/minodronate group showed a decreased incidence of new vertebral fractures during year 3 compared to that in year 2. In the patients who received minodronate in the original 2-year study, lumbar bone mineral density (BMD) increased consistently during year 3 and bone turnover markers decreased within the first 6 months and remained constant thereafter over 3 years. Similar positive effects of minodronate on BMD and bone turnover markers occurred when therapy was initiated in the placebo/minodronate group. No new safety concerns observed during the extension period compared to the safety observations made during the 2-year study. It was concluded that daily administration of 1 mg oral minodronate is safe and well tolerated, and that the efficacy of this dose in reducing vertebral fracture risk in postmenopausal women over 2 years is sustained with continuing treatment.

Topics: Aged; Aged, 80 and over; Bone Density Conservation Agents; Bone Resorption; Calcium, Dietary; Cholecalciferol; Cohort Studies; Combined Modality Therapy; Dietary Supplements; Diphosphonates; Double-Blind Method; Female; Humans; Imidazoles; Incidence; Lumbar Vertebrae; Middle Aged; Osteogenesis; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Time Factors

Menopause and increasing age are associated with a decrease in calcium absorption that can contribute to the pathogenesis of osteoporosis. We hypothesized that alendronate plus vitamin D(3) (ALN + D) would increase fractional calcium absorption (FCA). In this randomized, double-blind, placebo-controlled multicenter clinical trial, 56 postmenopausal women with 25-hydroxyvitamin D [25(OH)D] concentrations of 25 ng/mL or less and low bone mineral density (BMD) received 5 weekly doses of placebo or alendronate 70 mg plus vitamin D(3) 2800 IU (ALN + D). Calcium intake was stabilized to approximately 1200 mg/d prior to randomization. FCA was determined using a dual-tracer stable-calcium isotope method. FCA and 25(OH)D were similar between treatment groups at baseline (0.31 ± 0.12 ng/mL and 19.8 ± 4.7 ng/mL, respectively). After 1 month of treatment, subjects randomized to ALN + D experienced a significant least squares (LS) mean [95% confidence interval (CI)] increase in FCA [0.070 (0.042, 0.098)], whereas FCA did not change significantly in the placebo group [-0.016 (-0.044, 0.012)]. After ALN + D treatment, patients had higher 25(OH)D levels (LS mean difference 7.3 ng/mL, p < .001). The rise in serum 1,25-dihydroxyvitamin D(3) (p < .02) and parathyroid hormone (p < .001) were greater in the ALN + D group than in placebo-treated patients. ALN + D was associated with an increase in FCA of 0.07. To our knowledge, there is no other trial showing such a marked rise in calcium absorption owing to treatment with a bisphosphonate or owing to a small rise in 25(OH)D. This unique response of ALN + D is important for the treatment of osteoporosis, but the exact mechanism requires further study.

Topics: Aged; Aged, 80 and over; Alendronate; Bone Density Conservation Agents; Calcium; Cholecalciferol; Double-Blind Method; Endpoint Determination; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Placebos

Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D(3) 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70% of cases this was combined with vitamin D supplements. However, only 24% took ≥800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6% in the ALN/D5600 group compared with 31.0% in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57% vs. -46%, P < 0.001) and bone-specific alkaline phosphatase (-47% vs. -40%, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9% vs. 3.9%, P = 0.047) and the total hip (2.2% vs. 1.4%, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3% vs. 36.9%, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women.

Topics: Accidental Falls; Aged; Aged, 80 and over; Alendronate; Algorithms; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Diphosphonates; Drug Combinations; Female; Humans; Osteoporosis, Postmenopausal; Postmenopause; Standard of Care; Vitamin D Deficiency

We performed a randomized, double-blind, prospective, 16-week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis.. We randomly assigned 164 adults with osteoporosis to one of two treatment groups: weekly risedronate 35 mg and cholecalciferol 5600 IU combined in a single pill (RSD+) or weekly risedronate 35 mg alone (RSD). We measured serum levels of 25(OH)D, parathyroid hormone (PTH), and bone markers and performed muscle function tests, at baseline and after 16 weeks of treatment.. After 16 weeks of treatment, mean serum 25(OH)D increased significantly from 39·8 to 70·8 nmol/l in the RSD+ group and declined significantly from 40·5 to 35 nmol/l in the RSD group. Although both treatment groups had significant increases in serum PTH over baseline during the study, the RSD group had a significantly larger increase than the RSD+ group (13·6 vs 4·8 ng/l; P = 0·0005). In both groups, serum bone-specific alkaline phosphatase (BSAP) and C-terminal telopeptide (CTX) declined rapidly; there were no significant differences between groups. There was also no significant difference between groups in lower-extremity function tests. The overall incidence of clinical adverse events was not significantly different between groups.. In patients with osteoporosis, a once-weekly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D level over a 16-week treatment period without significant adverse events.

Topics: Aged; Alkaline Phosphatase; Asian People; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Collagen Type I; Double-Blind Method; Drug Therapy, Combination; Etidronic Acid; Female; Gastrointestinal Diseases; Humans; Korea; Male; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal; Parathyroid Hormone; Peptides; Prospective Studies; Radioimmunoassay; Risedronic Acid; Treatment Outcome; Vitamin D

Metabolic syndrome poses additional risk for postmenopausal women who are already at risk for osteoporosis. We hypothesized that a nutritional supplement containing anti-inflammatory phytochemicals and essential bone nutrients would produce a favorable bone biomarker profile in postmenopausal women with metabolic syndrome. In this 14-week, randomized trial, 51 women were instructed to consume a modified Mediterranean-style, low-glycemic-load diet and to engage in aerobic exercise. Those in the intervention arm (n = 25) additionally received 200 mg hop rho iso-alpha acids, 100 mg berberine sulfate trihydrate, 500 IU vitamin D₃, and 500 μg vitamin K₁ twice daily. Forty-five women completed the study. Baseline nutrient intake did not differ between arms. Compared with baseline, the intervention arm exhibited an approximate 25% mean decrease (P < .001) in serum osteocalcin (indicative of bone turnover), whereas the placebo arm exhibited a 21% increase (P = .003). Serum 25-hydroxyvitamin D increased 23% (P = .001) in the intervention arm and decreased 12% (P = .03) in the placebo arm. The between-arm differences for osteocalcin and 25-hydroxyvitamin D were statistically significant. Serum insulin-like growth factor I was statistically increased in both arms, but the between-arm differences were not statistically significant. Subanalysis showed that among those in the highest tertile of baseline insulin-like growth factor I, the intervention arm exhibited a significant increase in amino-terminal propeptide of type I collagen, whereas the placebo arm showed a significant decrease at 14 weeks. Treatment with rho iso-alpha acids, berberine, vitamin D₃, and vitamin K₁ produced a more favorable bone biomarker profile indicative of healthy bone metabolism in postmenopausal women with metabolic syndrome.

Topics: Anti-Inflammatory Agents; Berberine; Biomarkers; Bone and Bones; Cholecalciferol; Collagen Type I; Dietary Supplements; Female; Humans; Humulus; Insulin-Like Growth Factor I; Metabolic Syndrome; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Phytotherapy; Plant Extracts; Single-Blind Method; Vitamin D; Vitamin K 1; Vitamins

To study the therapeutic efficacy of embedding thread according to staging and wholism syndrome differentiation and its effect on correlated indices of patients with postmenopausal osteoporosis.. 135 patients with postmenopausal osteoporosis were randomly assigned to the control group A (treated with Calcichew D3 Tablet), the control group B (treated with Calcichew D3 Tablet and Xianling Gubao Capsule), and the treatment group (treated with Calcichew D5 Tablet and embedding thread according to staging and wholism syndrome differentiation). The visual analogue scale (VAS), Chinese medicine syndrome integral, and the quality of life scale before treatment, 3 months after treatment, and 6 months after treatment were assessed. Changes of the lumbar bone mineral density (BMD) and the serum level of estradiol (E2) were also assessed before and after six-month treatment. And the therapeutic efficacy of each group was also assessed after 6 months of treatment.. Before treatment, there was no significant difference in scores of VAS, Chinese medicine syndrome integral and the quality of life scale, the.serum level of E2, and the lumbar BMD of the patients in three groups (all P>0.05). After three months of treatment, there was significant difference in scores of VAS, Chinese medicine syndrome integral and the quality of life scale of the patients in the three groups (all P<0.01). Of them, the improvement of the three indices in the control group A was the worst in three groups (P< 0.05, P<0.01). The VAS in the treatment group was superior to those in control group B (P<0.01). But the difference of Chinese medicine syndrome integral and the quality of life scale was insignificant in the three groups. After six months of treatment, significant difference was shown in the scores of VAS, Chinese medicine syndrome integral, or the quality of life scale of the patients in the three groups when compared with the corresponding index before treatment and after three months of treatment (all P<0.01). Of them the improvement of the three indices of patients in the treatment group and the control group B was better than that in the control group A (all P<0.01), and the improvement in the treatment group were superior to that in the control group B (P<0.05, P<0. 01). Significant difference was shown in the serum level of E2 and the lumbar BMD of the patients in the treatment group and the control group B when compared with before treatment of the same group (both P<0.01). But there was no difference in the control group A between before and after treatment, with better effects obtained in the treatment group and the control group B. And the serum level of E, of the patients in the treatment group after treatment was higher than that in the control group B (P<0.01), but there was no difference in the lumbar BMD. The therapeutic efficacy in the treatment group and the control group B were superior to that in the control group A (P<0.01, P<0.05), but no difference existed between the treatment group and the control group B.. The therapy of embedding thread according to staging and wholism syndrome differentiation could reduce the scores of VAS and Chinese medicine syndrome integral, enhance the serum lever of E2, the quality of life scale and the lumbar BMD of patients with postmenopausal osteoporosis. So it was an effective method.

Topics: Aged; Cholecalciferol; Combined Modality Therapy; Complementary Therapies; Drugs, Chinese Herbal; Female; Humans; Medicine, Chinese Traditional; Middle Aged; Osteoporosis, Postmenopausal

Osteoporosis is a major health issue facing postmenopausal women. Increased production of pro-inflammatory cytokines resulting from declining estrogen leads to increased bone resorption. Nutrition can have a positive impact on osteoporosis prevention and amelioration. The objective of this study was to investigate the impact of targeted phytochemicals and nutrients essential for bone health on bone turnover markers in healthy postmenopausal women. In this 14-week, single-blinded, 2-arm placebo-controlled pilot study, all women were instructed to consume a modified Mediterranean-style low-glycemic-load diet and to engage in limited aerobic exercise; 17 randomized to the placebo and 16 to the treatment arm (receiving 200 mg hop rho iso-alpha acids, 100 mg berberine sulfate trihydrate, 500 IU vitamin D(3) and 500 microg vitamin K(1), twice daily). Thirty-two women completed the study. Baseline nutrient intake did not differ between arms. At 14 weeks, the treatment arm exhibited an estimated 31% mean reduction (P = 0.02) in serum osteocalcin (a marker of bone turnover), whereas the placebo arm exhibited a 19% increase (P = 0.03) compared to baseline. Serum 25-hydroxyvitamin D (25(OH)D) increased by 13% (P = 0.24) in the treatment arm and decreased by 25% (P < 0.01) in the placebo arm. The between-arm differences for OC and 25(OH)D were statistically significant. Serum IGF-I was increased in both arms, but the increase was more significant in the treatment arm at 14 weeks (P < 0.01). Treatment with hop rho iso-alpha acids, berberine sulfate trihydrate, vitamin D(3) and vitamin K(1) produced a more favorable bone biomarker profile that supports a healthy bone metabolism.

Topics: 25-Hydroxyvitamin D 2; Berberine; Biomarkers; Bone Density Conservation Agents; Bone Remodeling; Calcifediol; Cholecalciferol; Dietary Supplements; Female; Humans; Humulus; Insulin-Like Growth Factor I; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Phytotherapy; Pilot Projects; Plant Extracts; Postmenopause; Single-Blind Method; Vitamin K 1

Antifracture efficacy of high-dose vitamin D (800 IU) and calcium (1000 mg) remains controversial. To determine whether daily 800 IU of vitamin D and 1000 mg of calcium supplementation prevents fractures, we randomized 3432 women of the population-based Osteoporosis Risk Factor and Prevention (OSTPRE) Study cohort (ages 65 to 71 years) living in the region of northern Savonia, Finland (latitude 62 degrees to 64 degrees N) for 3 years to receive 800 IU of cholecalciferol and 1000 mg of calcium as calcium carbonate or to a control group that did not receive placebo. The main outcome measure was incident fractures. Fracture data were collected in telephone interviews and validated. Data on 3195 women, 1586 in the intervention group and 1609 in the control group, were available for analysis. In adjusted Cox proportional hazards models, the risk of any fracture decreased in the vitamin D and calcium group by 17% [adjusted hazard ratio (aHR) = 0.83; 95% confidence interval (CI) 0.61-1.12], and the risk of any nonvertebral fracture decreased by 13% (aHR = 0.87; 95% CI 0.63-1.19). The risk of distal forearm fractures decreased by 30% (aHR = 0.70; 95% CI 0.41-1.20), and the risk of any upper extremity fractures decreased by 25% (aHR = 0.75; 95% CI 0.49-1.16), whereas the risk of lower extremity fractures remained essentially equal (aHR = 1.02; 95% CI 0.58-1.80). None of these effects reached statistical significance. In conclusion, this study did not produce statistically significant evidence that vitamin D and calcium supplementation prevents fractures in a 65- to 71-year-old general population of postmenopausal women.

Topics: Aged; Calcium; Cholecalciferol; Dietary Supplements; Female; Finland; Fractures, Bone; Humans; Osteoporosis, Postmenopausal; Risk Factors

The Osteoporosis Risk Factor and Prevention-Fracture Prevention Study (OSTPRE-FPS) was a randomized population-based open trial (n = 593). The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo. Daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women.. vitamin D deficiency is common in the elderly, and vitamin D levels are associated with low bone mineral density (BMD). The working hypothesis was that vitamin D and calcium supplementation could prevent bone loss in ambulatory postmenopausal women.. the OSTPRE-FPS was a randomized population-based open trial with a 3-year follow-up in 3,432 women (aged 66 to 71 years). A randomly selected subsample of 593 subjects underwent BMD measurements. The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo.. in the intention-to-treat analysis, total body BMD (n = 362) increased significantly more in the intervention group than in the control group (0.84% vs. 0.19%, p = 0.011). The BMD change differences at the lumbar spine (p = 0.372), femoral neck (p = 0.188), trochanter (p = 0.085), and total proximal femur (p = 0.070) were statistically nonsignificant. Analyses in compliant women (≥ 80% of use) resulted in stronger and statistically significant effects at the total body and femoral regions.. daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women with adequate nutritional calcium intake.

Topics: Aged; Bone Density; Bone Density Conservation Agents; Calcium; Cholecalciferol; Dietary Supplements; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Osteoporosis, Postmenopausal; Treatment Outcome; Vitamin D

Low dietary Ca intake and vitamin D insufficiency have been implicated as part of the aetiology leading to osteoporosis. The aim of the present study was to examine the effects of a 30-month dietary intervention that combined supplementation of dairy products fortified with Ca and vitamin D3 and lifestyle and nutrition counselling sessions on bone mineral density (BMD) of postmenopausal women. Sixty-six postmenopausal women (aged 55-65 years) were randomised into a dietary group (DG; n 35), receiving daily and for the first 12 months 1200 mg Ca and 7.5 microg vitamin D3, while for the next 18 months of intervention 1200 mg Ca and 22.5 microg vitamin D3 through fortified dairy products, and a control group (CG; n 31) receiving neither counselling nor dairy products. The DG was found to have more favourable changes in arms (P < 0.001), total spine (P = 0.001) and total body BMD (P < 0.001) compared with the CG. Furthermore, a significant increase was observed for the DG in lumbar spine BMD (0.056; 95 % CI 0.009, 0.103), which was not found to differentiate significantly compared with the change observed in the CG (P = 0.075). In conclusion, the present study showed that intakes of vitamin D of about 22.5 microg/d and of Ca close to the recommended level of 1200 mg from fortified dairy foods for 30 months, with compliance ensured by lifestyle and nutrition counselling sessions, can induce favourable changes in arms, total spine and total body BMD of postmenopausal women.

Topics: Aged; Bone and Bones; Bone Density; Calcium; Cholecalciferol; Counseling; Dairy Products; Diet; Dietary Supplements; Drug Therapy, Combination; Female; Food, Fortified; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Single-Blind Method; Spine

Calcium is an essential cotherapy in osteoporosis treatment. The relative effectiveness of various calcium salts for this purpose is uncertain. Many older women with osteoporosis have phosphorus intakes of <70% of the Recommended Dietary Allowance.. Our objective was to test the hypothesis that calcium phosphate would better support anabolic bone building than would calcium carbonate.. This study was a 12-mo, randomized, positive-comparator, 2-arm, single-blind clinical trial in 211 patients treated with teriparatide who consumed <1000 mg phosphorus/d. Participants were randomly assigned to receive, in addition to teriparatide and 1000 IU cholecalciferol, 1800 mg calcium/d as either tricalcium phosphate or calcium carbonate. The primary endpoints were changes in lumbar spine and total hip bone mineral densities (BMDs); secondary endpoints were changes in bone resorption biomarkers and serum and urine calcium and phosphorus concentrations.. In the combined group, the lumbar spine BMD increased by 7.2%, and total hip BMD increased by 2.1% (P < 0.01 for both). However, there was no significant difference between calcium-treatment groups, and there were no significant between-group differences in serum calcium and phosphorus concentrations or in urine calcium concentrations. Bone resorption biomarkers increased in both groups, as expected with teriparatide, but the increases in the 2 calcium groups did not differ significantly.. Tricalcium phosphate and calcium carbonate appear to be approximately equally effective in supporting bone building with a potent anabolic agent; phosphate salt may be preferable in patients with restricted phosphorus intakes. This trial was registered at clinicaltrials.gov as NCT00074711.

Topics: Administration, Oral; Aged; Body Mass Index; Bone Density; Bone Development; Calcium; Calcium Carbonate; Calcium Phosphates; Cholecalciferol; Female; Humans; Injections, Subcutaneous; Middle Aged; Osteoporosis, Postmenopausal; Patient Selection; Single-Blind Method; Tablets

We investigated whether osteoporosis therapy with alendronate in postmenopausal patients is equally effective in patients who are vitamin D insufficient as in those who are vitamin D sufficient. We found that vitamin D insufficiency is common among patients with low bone density but that vitamin D insufficiency did not impair response to alendronate.. Treatment of vitamin D deficiency leads to significant improvements in bone mineral density (BMD); however, whether insufficiency affects BMD's response to bisphosphonate therapy is unknown.. To determine whether vitamin D insufficiency at initiation of alendronate therapy for low BMD affects treatment efficacy, we used data from 1,000 postmenopausal women randomly selected from the vertebral fracture arm (n = 2,027) of the placebo-controlled Fracture Intervention Trial of alendronate. Participants were randomly assigned to placebo (50%) or alendronate therapy and most (83%) to calcium (500 mg/day) and cholecalciferol (250 IU/day). We measured serum 25-hydroxy vitamin D (25OHD) at enrollment, then categorized baseline vitamin D status according to 25OHD concentration (10 but 30 ng/ml = sufficient) and used linear regression to compare the effects of alendronate treatment among these categories.. At baseline, participants were vitamin D sufficient (14%), insufficient (83%), and deficient (2%). We found that BMD response to therapy at total hip or spine did not vary by vitamin D status at baseline (p for heterogeneity = 0.6). We determined that vitamin D insufficiency is common among participants with low BMD. However, vitamin D status at initiation of therapy does not affect BMD's response to alendronate, when it is coadministered with cholecalciferol and calcium.

Topics: Absorptiometry, Photon; Aged; Alendronate; Bone Density; Bone Density Conservation Agents; Calcium; Cholecalciferol; Female; Femur Neck; Hip Joint; Humans; Osteoporosis, Postmenopausal; Spine; Vitamin D; Vitamin D Deficiency

This study reports on oral treatment with different doses of vitamin D3 ranging from 25 to 200 microg in females with 25-hydroxyvitamin D3 levels < 60 nmol/L screened for participation in an osteoporosis trial. A guidance to safely and efficiently achieve 25-hydroxyvitamin D3 levels > 60 nmol/L is presented.. The importance of vitamin D for skeletal health has been implemented in clinical trials in osteoporosis. The threshold of 25-hydroxyvitamin D for inclusion has changed from 30 to 60 nmol/L. This study reports on oral treatment with different doses of vitamin D3 in females with 25-hydroxyvitamin D3 levels < 60 nmol/L.. In 131 postmenopausal females screened for participation in an osteoporosis trial, the 25-hydroxyvitamin D3 concentration was < 60 nmol/L. They were treated with 25 (n = 22), 50 (n = 19), 75 (n = 19), 100 (n = 41) or 200 microg (n = 30) of vitamin D3 daily for at least 10 days.. In the females treated with 25, 50, 75, 100 and 200 microg of vitamin D3 daily the 25-hydroxyvitamin D3 concentrations increased significantly from 32.4 +/- 2.7 (mean +/- SEM) to 50.8 +/- 2.9, from 46.7 +/- 2.8 to 65.8 +/- 2.6, from 41.6 +/- 2.7 to 67.4 +/- 2.9, from 46.7 +/- 1.4 to 64.4 +/- 2.2 and from 42.1 +/- 2.0 to 71.2 +/- 2.8 nmol/L, respectively (p < 0.001). S-calcium increased significantly but within the reference range (p < 0.006).. Oral vitamin D3 safely increased 25-hydroxyvitamin D3 concentrations in all females above 60 nmol/L. This study demonstrates how to achieve the new recommended 25-hydroxyvitamin D concentrations within the screening period of a clinical trial.

Topics: Administration, Oral; Aged; Bone Density Conservation Agents; Calcifediol; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal

The remodeling transient describes a change in bone mass that lasts one remodeling cycle following an intervention that disturbs the calcium economy. We demonstrated the transient in a study of the response of bone density to calcium/vitamin D3 supplementation and show the hazards of misinterpretation if the transient is not considered.. The remodeling transient describes a change in bone mass that lasts for one remodeling cycle following an intervention that disturbs the calcium economy.. We report an intervention with calcium and vitamin D supplementation in 208 postmenopausal African-American women where the remodeling transient was considered a priori in the study design. Both groups (calcium alone vs. calcium + 20 microg (800 IU) vitamin D3) were ensured a calcium intake in excess of 1200 mg/day.. There were no differences between the two groups in changes in BMD over time. These BMD changes were therefore interpreted to reflect increased calcium intake in both groups but not any influence of vitamin D. A transient increase in bone mineral density was observed during the first year of study, followed by a decline. The remodeling period was estimated at about 9 months, which is similar to histomorphometric estimates.. It is problematic to draw conclusions concerning interventions that influence the calcium economy without considering the remodeling transient in study design. Studies of agents that effect bone remodeling must be carried out for at least two remodeling cycles and appropriate techniques must be used in data analysis.

Topics: Absorptiometry, Photon; Aged; Biomarkers; Black or African American; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Calcium; Cholecalciferol; Collagen Type I; Female; Femur; Humans; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Parathyroid Hormone; Peptides; Radius

In southern Europe, calcium supplementation alone is a common practice for osteoporosis prevention.. We examined whether calcium supplementation could be as effective in achieving favorable bone mass changes in postmenopausal women as is a holistic dietary approach including dairy products fortified with calcium and vitamin D3.. A sample of 101 postmenopausal women were randomly assigned to a dairy intervention group (n = 39) who received daily approximately 1200 mg Ca and 7.5 microg vitamin D3 via fortified dairy products and attended biweekly nutrition education sessions; a calcium-supplemented group (n = 26) who received a total of 1200 mg Ca/d; and a control group (n = 36).. The increases observed in serum concentrations of insulin-like growth factor I were greater in the dairy intervention group than in the 2 other groups, especially during the first 5 mo of intervention (P = 0.034). The decreases and increases observed during 5 and 12 mo, respectively, in serum 25-hydroxyvitamin D3 were significant in all groups (P = 0.050). Serum parathyroid hormone increased only in the control group, and serum type 1 collagen cross-linked C-telopeptide decreased only in the dairy intervention group during both 5 and 12 mo of intervention (P = 0.035 and 0.047, respectively). The dairy intervention group had greater improvements in pelvis (P = 0.040), total spine (P = 0.001), and total-body (P = 0.001) bone mineral density than did the other 2 groups.. The application of a holistic intervention approach combining nutrition education and consumption of fortified dairy products for 12 mo can induce more favorable changes in biochemical indexes of bone metabolism and bone mineral density than can calcium supplementation alone.

Topics: Aged; Biomarkers; Blood Chemical Analysis; Bone and Bones; Bone Density; Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Collagen Type I; Dairy Products; Dietary Supplements; Female; Food, Fortified; Humans; Insulin-Like Growth Factor I; Middle Aged; Nutritional Sciences; Osteoporosis, Postmenopausal; Peptides

Topics: Acetylcysteine; Administration, Oral; Animals; Antioxidants; Biomarkers; Bone Resorption; Calcium; Cholecalciferol; Collagen Type I; Double-Blind Method; Female; Humans; Mice; Middle Aged; Osteoporosis, Postmenopausal; Peptides; Pilot Projects; Postmenopause

Topics: Cholecalciferol; Dietary Supplements; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Osteoporosis, Postmenopausal; Treatment Outcome; Vitamin D

It is an important aim in the prevention of osteoporosis to stop or decelerate bone loss during the early postmenopausal years. Here we report on results of the 3-year EFOPS exercise trial in osteopenic women. The exercise strategy emphasized low-volume high-resistance strength training and high-impact aerobics. Forty-eight fully compliant women (55.1+/-3.3 years) with no medication or illness affecting bone metabolism participated in the exercise group (EG); 30 women (55.5+/-3.0 years) served as non-training controls (CG). At baseline there were no significant between-group differences with respect to physical fitness, bone mineral density, pain and nutritional status. The training consisted of two group training and two home training sessions per week. The study participants of both groups were individually supplemented with calcium and vitamin D (cholecalciferol). Bone mineral density (BMD) was measured by DXA at the lumbar spine, proximal femur and distal forearm and by QCT at the lumbar spine. Speed of sound and broadband ultrasound attenuation were determined at the calcaneus by quantitative ultrasound (QUS). Pain frequency and intensity at different skeletal sites were assessed via questionnaire. After 38 months, the following within-group changes were measured: DXA lumbar spine, EG: 0.8% n.s.; CG: -3.3% P<0.001; QCT trabecular ROI, EG: 1.1% n.s; CG: -7.7% P<0.001; QCT cortical ROI, EG: 5.3% P<0.001; CG: -2.6% P<0.001; DXA total hip: EG: -0.2% n.s; CG -1.9%, P<0.001; DXA distal forearm, EG: -2.8% P<0.001; CG: -3.8% P<0.001; BUA, EG: -0.3% n.s; CG -5.4% P<0.001; SOS, EG: 0.3% n.s; CG -1.0% P<0.001. At year 3 between-group differences relative to the exercise group were: DXA lumbar spine: 4.1% P<0.001; QCT trabecular ROI: 8.8% P<0.001; QCT cortical ROI: 7.9% P<0.001; DXA total hip: 2.1%, P<0.001; DXA distal forearm: 1.0% n.s.; BUA: 5.8% P<0.05; SOS: 1.3% P<0.001. Pain frequency and intensity in the spine significantly decreased in the exercise group and increased in the control group, while no between-group differences were detected in the main joints. In summary, over a period of 3 years our low-volume/high-intensity exercise program was successful to maintain bone mineral density at the spine, hip and calcaneus, but not at the forearm.

Topics: Aging; Anthropometry; Arthralgia; Bone Density; Calcium; Cholecalciferol; Dietary Supplements; Exercise Therapy; Female; Femur Neck; Follow-Up Studies; Forearm; Humans; Lumbar Vertebrae; Middle Aged; Nutritional Status; Osteoporosis, Postmenopausal; Patient Dropouts; Postmenopause

Many osteoporosis patients have low 25-hydroxyvitamin D (25OHD) and do not take recommended vitamin D amounts. A single tablet containing both cholecalciferol (vitamin D3) and alendronate would improve vitamin D status concurrently, with a drug shown to reduce fracture risk. This study assessed the efficacy, safety, and tolerability of a once-weekly tablet containing alendronate 70 mg and cholecalciferol 70 microg (2800 IU) (ALN + D) versus alendronate 70 mg alone (ALN).. This 15-week, randomized, double-blind, multi-center, active-controlled study was conducted during a season when 25OHD levels are declining, and patients were required to avoid sunlight and vitamin D supplements for the duration of the study. Men (n = 35) and postmenopausal women (n = 682) with osteoporosis and 25OHD >or= 9 ng/mL were randomized to ALN + D (n = 360) or ALN (n = 357).. Serum 25OHD, parathyroid hormone, bone-specific alkaline phosphatase (BSAP), and urinary N-telopeptide collagen cross-links (NTX).. Serum 25OHD declined from 22.2 to 18.6 ng/mL with ALN (adjusted mean change = -3.4; 95% confidence interval [CI]: -4.0 to -2.8), and increased from 22.1 to 23.1 ng/mL with ALN + D (adjusted mean change = 1.2; 95% CI: 0.6 to 1.8). At 15 weeks, adjusted mean 25OHD was 26% higher (p < 0.001, ALN + D versus ALN), the adjusted relative risk (RR) of 25OHD < 15 ng/mL (primary endpoint) was reduced by 64% (incidence 11% vs. 32%; RR = 0.36; 95% CI: 0.27 to 0.48 [p < 0.001]), and the RR of 25OHD < 9 ng/mL (a secondary endpoint) was reduced by 91% (1% vs. 13%; RR = 0.09; 95% CI: 0.03 to 0.23 [p < 0.001]). Antiresorptive efficacy was unaltered, as measured by reduction in bone turnover (BSAP and NTX).. In osteoporosis patients who avoided sunlight and vitamin D supplements, this once-weekly tablet containing alendronate and cholecalciferol provided equivalent antiresorptive efficacy, reduced the risk of low serum 25OHD, improved vitamin D status over 15 weeks, and was not associated with hypercalcemia, hypercalciuria or other adverse findings, versus alendronate alone.

Topics: Aged; Alendronate; Bone and Bones; Cholecalciferol; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal; Parathyroid Hormone; Postmenopause; Vitamin D

We examined the serum level of undercarboxylated osteocalcin (uc OC), which is a sensitive marker of vitamin K status, and levels of bone turnover markers in early postmenopausal women receiving vitamin K2 treatment with or without vitamin D3.. Thirty-four postmenopausal women with a mean age of 53 years whose bone mineral density (BMD) was less than 0.809 g/cm2 (osteopenia and osteoporosis) were treated with vitamin K2 or with a combination of vitamin K2 and vitamin D3. Seventeen women received daily oral administration of 45 mg vitamin K2 and 17 women received daily oral administration of 45 mg vitamin K2 plus 0.75 microg 1alpha-hydroxyvitamin D3. Serum levels of uc OC, intact osteocalcin (OC) and bone alkaline phosphatase (BAP), urinary deoxypyridinoline (DPD) levels and BMD at the lumbar spine were measured before and at 1 and 2 years after the start of treatment.. Serum uc OC levels in women treated with vitamin K2 alone and with both vitamin K2 and vitamin D3 decreased significantly (p < 0.05). Serum levels of intact OC and BAP in women treated with vitamin K2 did not show significant changes, while those in women who received the combined treatment decreased significantly (p < 0.05). On the other hand, urinary DPD level in women treated with vitamin K2 did not change, while that in women who received the combined treatment tended to decrease (p < 0.1).. Serum uc OC levels in early postmenopausal women who received vitamin K2 decreased due to carboxylation of uc OC. Combined treatment with vitamin K2 and vitamin D3 may be effective for sustaining BMD in early postmenopausal women whose bone turnovers are highly activated.

Topics: Alkaline Phosphatase; Amino Acids; Bone Density; Bone Density Conservation Agents; Bone Diseases, Metabolic; Cholecalciferol; Drug Therapy, Combination; Female; Humans; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Postmenopause; Vitamin K 2

We aimed to compare and evaluate the efficacies of a continuous regimen of intranasal salmon calcitonin (SCT) and two cyclic regimens (different cyclic regimens from previous studies) based on alternating 15 days or on 10 days consecutively per month for 1 year in the treatment of postmenopausal osteoporosis. We performed an open-label, prospective, randomized clinical trial. A total of 120 postmenopausal osteoporotic participants between 50 and 65 years old were randomly assigned to one of three treatment groups. Patients in group 1 (n = 40) received continuously SCT nasal spray at a dose of 200 IU/day, plus continuously 500 mg/day elementary calcium and 0.25 microg/day 1-alpha hydroxyvitamin D3, for 1 year. Patients in group 2 (n = 40) received cyclically SCT nasal spray at a dose of 200 IU/day on alternating 15 days per month, plus continuously 500 mg/day elementary calcium and 0.25 microg/day 1-alpha hydroxyvitamin D3, for 1 year. Patients in group 3 (n = 40) received cyclically SCT nasal spray on 10 days consecutively per month (20 days/month rest), plus continuously 500 mg/day elementary calcium and 0.25 microg/day 1-alpha hydroxyvitamin D3, for 1 year. Data was evaluated by repeated analysis of variance (ANOVA). In addition, statistical differences between groups were assessed by the two-tailed Student's t test. After 1 year of the study, seven patients from group 1, eight patients from group 2 and five patients from group 3 withdrew from the study. No patient discontinued the study because of adverse drug effects. There was a statistically-significant improvement in pain intensity VAS scores at the end of the year to baseline scores in all three groups (p < 0.001). There was no significant difference in pain intensity VAS scores between groups at the end of the year (p > 0.05). Lumbar and femur neck BMD scores improved significantly at the end of treatment in all three groups (p < 0.05). There was no statistically-significant difference in BMD scores between groups at final (p > 0.05). Urinary DPD/Cre levels decreased significantly in all three groups by the end of the year (p < 0.05). There was no statistically-significant difference in urinary DPD/Cre final levels between groups (p > 0.05). According to the results of the present study, consecutive 10 days therapy with SCT, which is the first in the literature to our knowledge, is as effective as the other two regimens in the treatment of osteoporosis. Both cyclic regimens in our study (alternat

Topics: Administration, Inhalation; Administration, Intranasal; Aged; Bone and Bones; Bone Density; Bone Density Conservation Agents; Calcitonin; Calcium; Cholecalciferol; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Pain; Radiography

To study the calcium homeostasis in healthy, calcium and vitamin D replete early postmenopausal women during oral supplementation with calcium and vitamin D3.. A prospective, placebo-controlled, randomised, double-single-blind, 3-week study.. Outpatient clinic at Copenhagen University Hospital, Denmark.. In all, 17 started, one was excluded. Totally, 16 healthy women, 45-61 y of age (mean 57.3 y) who were at least 4 y after menopause (mean 6.7 y) completed.. All underwent three consecutive 7-day study periods. Each began with 4 days of normal diet followed by 3 days treatment of either C: one tablet of 1.250 mg calcium carbonate (ie 500 mg Ca2+ per tablet) twice daily (breakfast and dinner), or CD3: as in C but plus 400 IU vitamin D3 b.i.d., or P (only) placebo tablets b.i.d.. At baseline plasma 25-hydroxycholecalciferol was normal (66+/-22 nmol/l) and the calcium intake without supplements 850 mg/day. In group C, the 24-h urinary calcium increased by 35% (6.9+/-2.0 mmol), vs the placebo group P (5.1+/-1.6 mmol) (P < 0.05). Addition of 800 IU vitamin D3 daily (CD3) did not increase calcium excretion further (6.6+/-2.1 mmol) but decreased plasma 1,25-(OH)2-vitamin D3 by 21% (P < 0.05).. In this carefully controlled study calcium plus vitamin D3 supplements only had minor influences of uncertain significance on the calcium balance in healthy, calcium and vitamin D sufficient early postmenopausal women.

Topics: Administration, Oral; Calcitriol; Calcium, Dietary; Cholecalciferol; Cross-Over Studies; Dietary Supplements; Dihydroxycholecalciferols; Double-Blind Method; Drug Synergism; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Postmenopause; Prospective Studies; Single-Blind Method

To investigate efficacy, tolerance and safety of the drug vitrum osteomag one tablet of which contains 600 mg calcium (1500 mg calcium carbonate), 200 IU of cholecalcepherol, 40 mg of magnesium, zinc (7.5 mg), copper (1 mg), manganese (1.8 mg) and boron (250 mcg) in women with osteopenia for prevention of osteoporosis.. A multicenter comparative open trial of vitrum osteomag influence on mineral bone density (MBD), change of pain syndrome in bones, index of calcium-phosphorous metabolism covered 334 postmenopausal women with osteopenia. MBD was measured in low-back spine and proximal part of the hip with DEXA method. All the patients were divided into 3 groups: 125 women taking 2 tablets of vitrum osteomag daily for 12 months (group 1); 111 women taking 1500 mg calcium carbonate (group 2); 96 women--control group (only observation).. Vitrum osteomag relieved pain in the back and joints, had a positive effect on bone density (+1.5%) and proximal parts of the hip (0.6-0.93%) exceeding the effect of calcium carbonate only which preserves the initial MBD in low back spine but does not prevent bone loss in the hip. MBD dynamics in patients given vitrum osteomag differs essentially from one in the control group (from -1.9 to -2.91%) which demonstrates a reliable preventive anti-osteoporotic effect of this medication. The drug increases the level of general and ionized calcium in blood but does not cause hypercalcemia lowering the level of parathormone in blood. The rate of side effects in group 1 was 14.4% and did not differ much from that in group 2 (16.2%).. The results of the study allow to recommend vitrum osteomag for prophylaxis of a rapid loss of bone tissue mineral density.

Topics: Absorptiometry, Photon; Aged; Bone Density; Calcium; Calcium Carbonate; Cholecalciferol; Dietary Supplements; Female; Femur; Humans; Lumbar Vertebrae; Magnesium; Middle Aged; Osteoporosis, Postmenopausal; Parathyroid Hormone; Trace Elements

The aim of the present study was to determine the safety and efficacy of combined therapy with raloxifene (RLX) and clodronate (CLD) in postmenopausal women. We enrolled 45 women with postmenopausal osteoporosis. The patients were randomly assigned to two different therapeutic groups: RLX 60 mg/day (n = 23) and RLX 60 mg/day plus CLD 100 mg intramuscularly (i.m.) once every 10 days (n = 22); 1 g of calcium and 800 IU of vitamin D3 were also given daily to both groups. Lumbar and femoral bone mineral density (BMD) were assessed at baseline and after 12 months of therapy using the dual X-ray absorptiometry technique (Norland XR36). We measured the bone turnover markers NTx and CTx, bone alkaline phosphatase (BAP) and osteocalcin at baseline and after 12 months of therapy. Our data demonstrate that 1 year of combined RLX+CLD therapy induced a higher increase in lumbar BMD than treatment with RLX alone as well as a major decrease in bone resorption markers, suggesting an additive effect of CLD on bone mass and inhibition of bone turnover. Furthermore, after 1 year of therapy levels of bone formation markers (osteocalcin and BAP) had increased in both groups, but the increase in osteocalcin and BAP was significantly higher in the RLX+CLD treated group, suggesting that, in addition to its inhibitory effects on resorption, CLD might also have stimulatory effects on mature osteoblast activity.

Topics: Absorptiometry, Photon; Aged; Biomarkers; Bone Density; Bone Remodeling; Bone Resorption; Cholecalciferol; Clodronic Acid; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators

To investigate the therapeutic effect of combined use of vitamin K(2) and D(3) on vertebral bone mineral density in postmenopausal women with osteopenia and osteoporosis.. We enrolled 172 women with vertebral bone mineral density <0.98 g/cm(2) (osteopenia and osteoporosis) as measured by dual-energy X-ray absorptiometry. In this study, we employed the criteria for diagnosis of osteopenia and osteoporosis using dual energy X-ray absorptiometry proposed by the Japan Society of Bone Metabolism in 1996. Subjects were randomized into four groups (each having 43 subjects in vitamin K(2) therapy group, vitamin D(3) therapy group, vitamin K(2) and D(3) combined therapy group, or a control group receiving dietary therapy alone) and treated with respective agents for 2 years, with bone mineral density was measured prior to therapy and after 6, 12, 18, and 24 months of treatment. The bone metabolism markers analyzed were serum type 1 collagen carboxyterminal propeptide (P1CP), serum intact osteocalcin, and urinary pyridinoline. Tests of blood coagulation function consisted of measurement of activated partial thromboplastin time (APTT) and analysis of concentrations of antithrombin III (AT III), fibrinogen, and plasminogen.. Combined therapy with vitamin K(2) and D(3) for 24 months markedly increased bone mineral density (4.92 +/- 7.89%), while vitamin K(2) alone increased it only 0.135 +/- 5.44%. The bone markers measured, revealed stimulation of both bone formation and resorption activity. We observed an increase in coagulation and fibrinolytic activity that was within the normal range, suggesting that balance was maintained in the fibrinolysis-coagulation system.. Continuous combination therapy with vitamin K(2) and D(3) may be useful for increasing vertebral bone mass in postmenopausal women. Furthermore, the increase in coagulation function observed during this therapy was within the physiological range, and no adverse reactions were observed.

Topics: Absorptiometry, Photon; Amino Acids; Antithrombin III; Blood Coagulation Tests; Bone Density; Cholecalciferol; Drug Administration Schedule; Drug Therapy, Combination; Female; Fibrinogen; Humans; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Peptide Fragments; Plasminogen; Procollagen; Treatment Outcome; Vitamin K 2

Vitamin D deficiency leads to secondary hyperparathyroidism, increased bone turnover, and bone loss and, when severe, to osteomalacia. Vitamin D deficiency is common in elderly people, especially the institutionalized. The definition of vitamin D deficiency is hampered by the fact that large interlaboratory differences exist in assays for serum 25-hydroxyvitamin D (25OHD), the main circulating metabolite. The international Multiple Outcomes of Raloxifene Evaluation study, a large prospective intervention trial in postmenopausal women with osteoporosis, offered the opportunity to compare vitamin D status and parathyroid function throughout many countries over the world. For this study, baseline data were available from 7564 postmenopausal women from 25 countries on 5 continents. All women had osteoporosis, i.e. bone mineral density (BMD) at femoral neck or lumbar spine was lower than t-score -2.5, or they had 2 vertebral fractures. Serum 25OHD was measured by RIA, and serum PTH was measured by immunoradiometric assay. BMD was measured by dual x-ray absorptiometry. The mean (+/-SD) serum 25OHD was 70.8 +/- 30.9 nmol/L. A low serum 25OHD (<25 nmol/L) was observed in 4.1% of all women in the Multiple Outcomes of Raloxifene Evaluation study, ranging from 0% in south east Asia (very few patients) to 8.3% in southern Europe. Serum 25OHD was between 25-50 nmol/L in 24.3% of the women. Serum 25OHD showed a significant seasonal relationship, with lower values in all regions in winter. Serum PTH correlated negatively with serum 25OHD (r = -0.25; P < 0.001). This significant negative correlation was observed in all regions. When serum 25OHD was less than 25, 25-50, or more than 50 nmol/L, respectively, mean serum PTH levels were 4.8, 4.1, and 3.5 pmol/L, respectively (by ANOVA, P < 0.001). Similarly, mean alkaline phosphatase levels were 83.7, 79.1, and 75.7 U/L (P < 0.001), respectively, with increasing serum 25OHD. The effect of serum 25OHD on BMD was only significant for the BMD of the trochanter where a serum 25OHD level less than 25 nmol/L was associated with a 4% lower BMD. After 6 months of treatment with vitamin D(3) (400-600 IU/day) and calcium (500 mg/day), serum 25OHD increased from 70.8 +/- 29.8 to 92.3 +/- 28.6 nmol/L. Serum PTH decreased significantly after 6 months of treatment, and this decrease depended on baseline serum 25OHD. When baseline serum 25OHD was less than 25, 25-50, or more than 50 nmol/L, respectively, serum PTH decreased by 0.8, 0.5, or

Topics: Absorptiometry, Photon; Adult; Aged; Aged, 80 and over; Aging; Alkaline Phosphatase; Bone Density; Calcifediol; Calcium; Cholecalciferol; Female; Humans; Immunoradiometric Assay; Middle Aged; Nutritional Status; Osteoporosis, Postmenopausal; Parathyroid Hormone; Postmenopause; Radioimmunoassay; Raloxifene Hydrochloride; Seasons

We ascertained the safety and efficacy of fluoride in augmenting spinal bone mass and reducing spinal fractures in older women with established osteoporosis. We compared a combination of sustained-release sodium fluoride, calcium citrate, and cholecalciferol (SR-NaF group) with calcium and cholecalciferol alone (control group).. Eighty-five ambulatory women aged 65 years or older with 1 or more nontraumatic vertebral compression fractures were enrolled in a 42-month randomized, double-blind, placebo-controlled trial. Primary outcome measures were vertebral fracture rate, bone mass, and safety.. The vertebral fracture rate determined by means of computer assistance in the SR-NaF group was significantly lower than that in the control group (relative risk [RR], 0.32; 95% confidence interval [CI], 0.14-0.73; P =.007). Results of visual adjudicated inspection also confirmed a significant reduction in fracture rate (RR, 0.40; 95% CI, 0.17-0.95; P =.04). Bone mineral density in L2 through L4 increased significantly from baseline in the SR-NaF group by 5.4% (95% CI, 2.7%-8.2%; P<.001), and by 3.2% in the control group (95% CI, 0.8%-5.6%; P =.01). The between-group differences in bone mineral density were not significant. The femoral neck and total hip bone mineral density remained stable in the SR-NaF group and was not significantly different from that of the control group. There were no significant differences in adverse effects between groups.. The SR-NaF group significantly decreased the risk for vertebral fractures and increased spinal bone mass without reducing bone mass at the femoral neck and total hip.

Topics: Aged; Ambulatory Care; Blood Cell Count; Bone Density; Calcium; Calcium Citrate; Cholecalciferol; Collagen; Collagen Type I; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Occult Blood; Osteoporosis, Postmenopausal; Peptides; Radiography; Reticulocyte Count; Sodium Fluoride; Spinal Fractures

Hormone replacement therapy (HRT) prevents postmenopausal bone loss and fractures. However, the occurrence of women with no bone response to HRT has not been widely examined. We identified the densitometric nonresponders to long-term HRT and investigated some characteristics and biochemical variables as possible predictors of densitometric nonresponse in postmenopausal women. The study population was a subsample of the Kuopio Osteoporosis Study (n = 14,220). A total of 464 early postmenopausal women were randomized into four treatment groups: (1) HRT (sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate); (2) vitamin D3; (3) HRT + Vitamin D3 combined; and (4) placebo. In this study, the data from HRT and placebo groups were analyzed. Lumbar (L2-4) and femoral neck bone mineral density (BMD) were determined by dual-energy X-ray absorptiometry (DXA) at baseline and after 5 years of treatment. A densitometric nonresponder was defined as a woman whose 5-year BMD change was similar to the mean BMD change (+95% CI) of the placebo group or worse. Altogether, 74 women in the HRT group and 104 women in the placebo group complied with the treatment. According to spinal BMD analysis, 11% of the women were classified as densitometric nonresponders; the corresponding proportion for femoral BMD analysis was 26%. Both smoking (p = 0.003) and low body weight (p = 0.028) were significant risk factors for densitometric nonresponse to HRT. After 6 months of treatment the densitometric nonresponders (hip) had a significantly higher mean serum follicle stimulating hormone (FSH) level (p = 0.038) and lower increases in serum estradiol levels (p = 0.006) than the densitometric responders. The mean changes in serum FSH and alkaline phosphatase levels were significantly lower among the densitometric nonresponders (spine) than responders (p = 0.043 and 0.017, respectively). In conclusion, this prospective study shows that especially current smokers and women with low body weight are at increased risk of poor bone response to HRT. Repeated serum FSH, estradiol and alkaline phosphatase measurements during the first months of long-term HRT may be helpful in identifying the women with no bone response to HRT.

Topics: Alkaline Phosphatase; Biomarkers; Body Weight; Bone and Bones; Bone Density; Cholecalciferol; Estradiol; Estrogen Replacement Therapy; Estrogens; Female; Follicle Stimulating Hormone; Humans; Middle Aged; Osteoporosis, Postmenopausal; Prospective Studies; Smoking; Treatment Failure

Improvement of vitamin D and K status of about 60 -y-old postmenopausal Dutch women.. In a randomized study postmenopausal women with normal (T-score >-1; n=96) and low (T-score< or =-1; n=45) bone mineral density (BMD) of the lumbar spine, were supplemented with 350-400 IU vitamin D(3), 80 microg vitamins K(1) vitamins K(1)+D(3), or placebo for 1 y. Serum 25-hydroxyvitamin D [25(OH)D] and percentage carboxylated osteocalcin (%carbOC) were measured at baseline and after 3, 6 and 12 months.. Baseline %carbOC of the entire study population was positively correlated with BMD of the lumbar spine and femoral neck. Correspondingly, women with low BMD had lower %carbOC at baseline than women with normal BMD but this difference disappeared after 1 y of supplementation with vitamin K(1) ((mean+/-s.d.) 68+/-11% (95% CI, 64. 5-71.2%) vs 72+/-6% (95% CI, 70.1-72.9%), respectively). One year of supplementation with vitamin D(3) showed maximum increases in 25(OH)D of 33+/-29% (95% CI, 24.8-41.8%) and 68+/-58% (95% CI, 50.1-84.6%) in women with normal and low BMD, respectively. During winter, however, a 29% decline in maximum 25(OH)D levels was not prevented in women with low BMD.. Daily supplementation of Dutch postmenopausal women with >400 IU vitamin D(3) is indicated to prevent a winter decline in 25(OH)D and to control serum parathyroid hormone levels. Daily supplementation with 80 microg vitamin K(1) seems to be necessary to reach premenopausal %carbOC levels. A stimulatory effect of calcium and/or vitamin D on %carbOC cannot be excluded. European Journal of Clinical Nutrition (2000) 54, 626-631.

Topics: Aged; Bone Density; Calcifediol; Cholecalciferol; Dietary Supplements; Female; Humans; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Time Factors; Vitamin K 1

The effect of the combined administration of vitamin D3 and vitamin K2 on bone mineral density (BMD) of the lumbar spine was examined in postmenopausal women with osteoporosis. Ninety-two osteoporotic women who were more than 5 years after menopause, aged 55-81 years, were randomly divided into four administration groups: vitamin D3 (1alpha hydroxyvitamin D3, 0.75 microg/day) (D group; n = 29), vitamin K2 (menatetrenone, 45 mg/day) (K group; n = 22), vitamin D3 plus vitamin K2 (DK group, n = 21), and calcium (calcium lactate, 2 g/day) (C group; n = 20). BMD of the lumbar spine (L2-L4) was measured by dual energy X-ray absorptiometry at 0, 1, and 2 years after the treatment started. There were no significant differences in age, body mass index, years since menopause, and initial BMD among the four groups. One-way analysis of variance (ANOVA) with repeated measurements showed a significant decrease in BMD in the C group (P < 0.001). Two-way ANOVA with repeated measurements showed a significant increase in BMD in the D and K groups compared with that in the C group (P < 0.05 and P < 0.001, respectively), and a significant increase in BMD in the DK group compared with that in the C, D, and K groups (P < 0.0001, P < 0.05 and P < 0.01, respectively). These findings indicate that combined administration of vitamin D3 and vitamin K2, compared with calcium administration, appears to be useful in increasing the BMD of the lumbar spine in postmenopausal women with osteoporosis.

Topics: Aged; Aged, 80 and over; Bone Density; Cholecalciferol; Drug Therapy, Combination; Female; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Vitamin K

The long term effects of hormone replacement therapy (HRT) and vitamin D3 (Vit D) on bone mineral density (BMD) were studied. A total of 464 nonosteoporotic early postmenopausal women from the Kuopio Osteoporosis Study (n = 13100) were randomized to four groups: 1) HRT (sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate, 2) Vit D3 (300 and 100 IU/day during the fifth year), 3) HRT and Vit D combined, and 4) placebo. Lumbar (L2-L4) and femoral neck BMD were determined by dual x-ray absorptiometry (DXA) at baseline and after 2.5 and 5 yr of treatment. Intention to treat analysis (n = 464) showed that after 5 yr, lumbar BMD remained unchanged in the HRT and HRT plus Vit D groups [+0.2% (P = 0.658) and +0.9% (P = 0.117), respectively], whereas lumbar BMD decreased by 4.6% in the Vit D group and by 4.5% in the placebo group (P < 0.001 in both). The loss of femoral neck BMD was less in the HRT (-1.4%; P = 0.005) and HRT plus Vit D (-1.3%; P = 0.003) groups than in the Vit D and placebo groups (-4.3%; P < 0.001 in both). Among those 370 women who complied with the 5-yr treatment, the effect was more pronounced: lumbar BMD had increased by 1.5% in the HRT (P = 0.009) and by 1.8% in the HRT plus Vit D group (P = 0.005), with a plateau after 2.5 yr, whereas lumbar BMD had decreased in both the Vit D and placebo groups (4.6% and 4.7%; P < 0.001, respectively). Femoral neck BMD decreased again less in the HRT (-0.4%) and HRT plus Vit D (-0.6%) groups than in the Vit D and placebo groups (-4.4% in both). This study confirms the positive long term effect of HRT on BMD also seen in intention to treat analysis. The data suggest that low dose vitamin D3 supplementation does not prevent bone loss in healthy, nonosteoporotic, early postmenopausal women, and it confers no benefit additional to that of HRT alone.

Topics: Cholecalciferol; Cyproterone Acetate; Estradiol; Estrogen Replacement Therapy; Female; Femur; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Placebos; Postmenopause

To investigate the effect of vitamin K2 treatment for a year on spinal bone mineral density (BMD) in postmenopausal women, comparing with vitamin D3 hormone replacement therapy and to determine the factors which affect the efficacy of vitamin K2 therapy.. Seventy-two postmenopausal women were randomized into four groups and treated with respective agents. Before the therapy, 6 and 12 months after the treatment, their lumbar spine BMD were measured by dual energy X-ray absorptiometry. The rates of change in BMD (delta BMD) were calculated. Correlations of BMD with age, year since menopause and the initial BMD were determined.. Vitamin K2 suppressed the decrease in spinal BMD as compared with no treatment group. BMD in women treated with vitamin K2 was inversely correlated with their age (r = -0.54; P < 0.05).. Vitamin K2 therapy may be a useful method for preventing postmenopausal spinal bone mineral loss. In addition, the therapy should be started early in postmenopausal period.

Topics: Bone Density; Cholecalciferol; Estrogen Replacement Therapy; Female; Humans; Longitudinal Studies; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Vitamin K; Vitamin K 2

Raloxifene, a selective estrogen receptor modulator (SERM), has been shown to improved bone mineral density (BMD) and serum lipid profiles in healthy postmenopausal women. The objective of this study was to examine the effects of raloxifene on BMD, biochemical markers of bone metabolism and serum lipids in postmenopausal women with low bone density or osteoporosis. This Phase II, multicenter, 24-month, double-masked study assessed the efficacy and safety of raloxifene in 129 postmenopausal women (mean age +/- SD: 60.2 +/- 6.7 years) with osteoporosis or low bone density (baseline mean lumbar spine BMD T-score: -2.8). Women were randomly assigned to one of three treatment groups: placebo, 60 mg/day raloxifene-HCl (RLX 60) or 150 mg/day raloxifene-HCL (RLX 150) and concomitantly received 1000 mg/day calcium and 300 U/day vitamin D3. At 24 months, BMD was significantly increased in the lumbar spine (+3.2%), femoral neck (+2.1%), trochanter (+2.7%) and total hip (+1.6%) in the RLX 60 group compared with the placebo group (p < 0.05). The RLX 150 group had increases in BMD similar to those observed with RLX 60. A greater percentage of raloxifene-treated patients, compared with those receiving placebo, had increased BMD (p < 0.05). Serum bone-specific alkaline phosphatase activity, serum osteocalcin, and urinary type I collagen:creatinine ratio were significantly decreased in the RLX-treated groups, compared with the placebo group (p < 0.01). RLX 60 treatment significantly decreased serum levels of triglycerides, and total- and LDL-cholesterol levels (p < 0.01). The rates of patient discontinuation and adverse events were not significantly different among groups. In this study, raloxifene increased bone density, decreased bone turnover, and improved the serum lipid profile with minimal adverse events, and may be a safe and effective treatment for postmenopausal women with osteoporosis or low bone density.

Topics: Aged; Biomarkers; Bone Density; Bone Remodeling; Calcium; Cholecalciferol; Cholesterol; Cholesterol, LDL; Double-Blind Method; Estrogen Antagonists; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators

The long-term effects on bone of estrogen therapy (HRT) combined with vitamin D3 supplementation were evaluated and compared with the effects of HRT without vitamin D3 supplementation in a 4-year prospective, partly randomized study among 60 osteoporotic women (mean age 55.4 years; range 49.7-59.4 years). The women studied were a subgroup of the population-based Kuopio Osteoporosis Risk Factor and Prevention Study (OSTPRE) (n = 13,100). The bone mineral densities (BMD) of the lumbar spine and femoral neck were determined by dual-energy X-ray absorptiometry (DXA) in 3236 perimenopausal women. Those 106 women with baseline BMD more than 2 SDs less than the mean value in this population, either at the lumbar spine (BMD < 0.826 g/cm2) and/or femoral neck (BMD < 0.684 g/cm2), were offered treatment for osteoporosis. After exclusions, 60 women were included in the analyses. Group allocation was: HRT (estradiol valerate (2 mg) plus cyproterone acetage, 1 mg, sequentially: ClimenR) (n = 21); HRT + Vit D: Climen + vitamin D3 (cholecalciferol, 300 IU/day, no intake during June-August) (n = 23); controls: 16 women who refused all treatment served as a non-randomized control group. In the HRT group, the highly significant increase in lumbar BMD was 5.4%, 5.3%, 4.7% and 4.0% after 1, 2, 3 and 4 years of treatment, respectively, all compared with the baseline values and with the control group. The increase in femoral neck BMD was statistically insignificant (1.4%, 2.2%, 1.9% and 2.1%, respectively; p > 0.05). In the HRT + Vit D group, the lumbar BMD increased by 3.7%, 4.9%, 4.9% and 4.9% (p < 0.001), whereas the 5.8% increase in femoral neck BMD reached significance at 4 years (p < 0.01) when compared with the control group as well as with the baseline values. However, there were no statistically significant differences in lumbar or femoral BMD changes between the two HRT groups. In conclusion, estrogen can substantially increase lumbar bone mass in patients with postmenopausal osteoporosis. In addition, the combination of HRT and vitamin D3 may increase femoral neck BMD in osteoporotic women more than estrogen alone.

Topics: Androgen Antagonists; Bone Density; Cholecalciferol; Cyproterone Acetate; Drug Therapy, Combination; Estradiol; Estrogen Replacement Therapy; Female; Femur Neck; Humans; Middle Aged; Osteoporosis, Postmenopausal; Statistics, Nonparametric

We undertook a double-masked, randomized, placebo-controlled trial to evaluate the effect of a calcium and vitamin D supplement and a calcium supplement plus multivitamins on bone loss at the hip, spine and forearm. The study was performed in 240 healthy women, 58-67 years of age. Duration of treatment was 2 years. Bone mineral density (BMD) was measured at the lumbar spine, hip and forearm. A dietary questionnaire was administered twice during the study and revealed a fairly good calcium and vitamin D intake (919 mg calcium/day; 3.8 micrograms vitamin D/day). An increase in lumbar spine BMD of 1.6% was observed in the treatment group after 2 years (p < 0.002). In the placebo group no significant changes were observed during the 2 years. Lumbar spine BMD was significantly higher in the treatment group at both 1 (p < 0.01) and 2 years (p < 0.05) compared with the placebo group. Though not significant, the same trend was seen at the hip. No significant changes from baseline values were observed at the distal forearm in either the treatment or the placebo group. In conclusion, we found a significant increase in urinary calcium excretion in the treatment group compared with the placebo group. Together with significant changes in serum calcium and serum parathyroid hormone, this indicates that a long-term calcium and vitamin supplement of 1 g elementary calcium (calcium carbonate) and 14 micrograms vitamin D3 increases intestinal calcium absorption. A positive effect on BMD was demonstrated, even in a group of early postmenopausal age, with a fairly good initial calcium and vitamin D status.

Topics: Aged; Bone Density; Calcium; Cholecalciferol; Double-Blind Method; Female; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Parathyroid Hormone

Recent studies suggest that variations of the vitamin D receptor (VDR) gene are related to bone mineral density (BMD). In this study, we examined the effect of vitamin D3 supplementation on BMD at the femoral neck in relation to VDR genotype. We analyzed 81 women, age 70 years and over, who participated in a placebo-controlled clinical trial on the effect of vitamin D3 supplementation (400 IU daily for at least 2 years) on BMD and fracture incidence. VDR genotype was based on the presence (b) or absence (B) of the BsmI restriction site. Mean BMD of the right and left femoral neck was measured at baseline and after 1 and 2 years. Dietary calcium, body mass index, and years since menopause were assessed at baseline while biochemical markers were measured at baseline and after 1 year. There was no difference among the BB, Bb, and bb genotype for baseline measurements of BMD at the femoral neck (mean and SD, g/cm2: 0.70 (0.10), 0.71 (0.12), and 0.69 (0.10), respectively), nor for any of the biochemical indices. The mean increase of BMD in the vitamin D group relative to the placebo group, expressed as percentage of baseline BMD, was significantly higher (p = 0.03) in the BB (delta BMD: 4.4%, p = 0.04) and Bb genotype (delta BMD: 4.2%, p = 0.007) compared with the bb genotype (delta BMD: -0.3%, p = 0.61). No significant changes were found for any of the other measured parameters. The VDR genotype-dependent effect of vitamin D supplementation in these elderly subjects suggest a functional involvement of VDR gene variants in determining BMD.

Topics: Absorptiometry, Photon; Aged; Aged, 80 and over; Biomarkers; Body Mass Index; Bone Density; Calcium, Dietary; Cholecalciferol; Female; Femoral Neck Fractures; Femur Neck; Genotype; Humans; Longitudinal Studies; Osteoporosis, Postmenopausal; Receptors, Calcitriol

Osteoporosis is a common disorder in postmenopausal women, which is probably due to decreased ovarian function. Currently, hormone replacement therapy (HRT), involving administration of estrogen and progestogen, is successfully applied to reduce bone resorption. We studied the effect of HRT on 23 postmenopausal women. This consisted of a combination of 17 beta-estradiol and dydrogesterone, on the serum level of 1,25-dihydroxyvitamin D (1,25(OH)2D) after 0, 6, 12, and 24 months. We found mean serum concentrations (+/- SD) of 1,25(OH)2D of 130.5 pmol/liter (46.1), 152.7 pmol/liter (45.1), 170.8 pmol/liter (64.0), and 155.2 pmol/liter (59.7), respectively. The baseline values in these women were found to be significantly lower than those during therapy (P < or = 0.005). No statistically significant differences were observed when comparing the estrogen-only phase with the combined estrogen-progestogen phase. It is concluded that HRT results in an increase in the serum 1,25(OH)2D concentration which lasts for at least 2 years. This increase may partly explain the preventive effect of HRT on osteoporosis. Furthermore, these results suggest that dydrogesterone does not influence the estrogen-induced changes in serum 1,25(OH)2D concentration.

Topics: Administration, Oral; Bone Resorption; Calcitriol; Cholecalciferol; Dydrogesterone; Estradiol; Estrogen Replacement Therapy; Female; Humans; Longitudinal Studies; Middle Aged; Osteoporosis, Postmenopausal; Prospective Studies; Radioligand Assay

Fifty patients with advanced osteoporosis were treated for 2 years with calcitonin+fluoride using cyclic therapeutic regimens. We evaluated their efficacy in recovering bone loss and reducing the rate of vertebral crush fractures. Twenty-seven control patients were treated for one year with calcium+vitamin D supplements. In the 59% of patients who responded to calcitonin the gain in bone mass (dual photon absorptiometry) correlated inversely with urine calcium and hydroxyproline excretion and serum osteocalcin. In the 70% responding to calcitonin+fluoride it correlated positively with serum osteocalcin and alkaline phosphatase and inversely with urine calcium and hydroxyproline excretion. Compared to basal value both coherent regimens resulted in a significant increase (calcitonin: 1.92 +/- 1.8%, p < 0.01; calcitonin+fluoride: 3.7 +/- 1.4%, p < 0.0005) in spinal bone mass but no significant differences emerged between them. The rate of vertebral crush fractures (radiogrammetry) did not very significantly in any group. The gain in bone mass does not predict the risk of vertebral crush fractures.

Topics: Adult; Aged; Analysis of Variance; Bone Density; Calcitonin; Calcium; Cholecalciferol; Drug Therapy, Combination; Female; Fluorides; Fractures, Spontaneous; Humans; Incidence; Middle Aged; Osteoporosis, Postmenopausal; Regression Analysis; Spinal Fractures

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Female; Humans; Osteoporosis, Postmenopausal; Postmenopause; Vitamin D; Vitamin D Deficiency

This study was performed to evaluate quality of life (QOL) and patient satisfaction with raloxifene/cholecalciferol combination therapy in postmenopausal women with low bone mass. This multicenter, prospective, noninterventional observational study included 3907 postmenopausal women who received a combination of raloxifene 60 mg and cholecalciferol 800 IU daily to treat or prevent osteoporosis. Changes in QOL and patient satisfaction were evaluated after 3 and 6 months of treatment. In addition, the safety profile was assessed. Mean age was 67.7 ± 9.3 years old. QOL, assessed by European Quality of life instrument 5 Dimensions (EQ-5D) index, improved significantly after 3 months (0.81 ± 0.11, P < 0.001) and 6 months (0.82 ± 0.11, P < 0.001) of treatment compared to the baseline (0.78 ± 0.14). Improvement in QOL was also significant regardless of previous regimens both in women who were switched from other drugs (bisphosphonates or selective estrogen receptor modulators) and in women who received the study drug for the first time (P < 0.001 for all comparisons). Percentage of women satisfied with the effects (from 37.3 to 67.7%, P < 0.001) and convenience (from 42.8 to 74.1%, P < 0.001) of treatment compared to previous medication significantly increased after 6 months of treatment. In addition, serious adverse drug reactions did not occur, and hot flushes were observed only in 12 women (0.3%). Combination therapy with raloxifene and cholecalciferol significantly improves quality of life with no serious adverse events and high patient satisfaction at 6 months. Our real-world data suggest that this regimen is a promising option for postmenopausal women with low bone mass.

Topics: Aged; Cholecalciferol; Female; Humans; Male; Middle Aged; Osteoporosis, Postmenopausal; Patient Satisfaction; Postmenopause; Prospective Studies; Quality of Life; Raloxifene Hydrochloride

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Female; Humans; Osteoporosis, Postmenopausal; Postmenopause; Vitamin D

Several formulations of vitamin D and alendronate are available for the treatment of osteoporosis. The objective of this study was to examine efficacy and safety of calcifediol (25(OH)D) compared to cholecalciferol (vitamin D3) and also the relationship between different formulations of alendronate and adverse reactions.. We observed a population of women diagnosed with postmenopausal osteoporosis or osteopenia treated with alendronate 70 mg weekly associated to vitamin D3 or 25(OH)D at monthly total dose of 625 µg. Data collected both at baseline (T0) and at follow-up after at least 12 months of therapy (T1) were: demographic characteristics, BMI, full medical history, lumbar T-score, femur T-score, calcium, osteocalcin, alkaline phosphatase, PTH and vitamin D blood level.. A total of 362 patients were enrolled in the study. Alendronate 70 mg + calcifediol (A+25(OH)D) group consisted of 202 patients while 160 patients were treated with alendronate 70 mg + cholecalciferol (A+D3). In the A+25(OH)D group, we observed a significant increase in lumbar T-score value (0.26±0.35 vs. 0.13±0.3) and serum vitamin D (20.64±20.71 vs. 6.07±7.61 ng/mL) levels compared to the A+D3 group (P<0.05). The lowest incidence of gastrointestinal adverse reactions was observed among patients taking alendronate 70 mg in drinkable solution form (P<0.05).. Alendronate 70 mg with calcifediol gives a better outcome in the treatment of osteoporosis according to lumbar T-score and vitamin D serum level observed at one-year follow-up compared to alendronate 70 mg with cholecalciferol. Both vitamin D formulations did not show to cause hypercalcemia in this study. Alendronate 70 mg in drinkable solution form is also associated with lowest incidence of gastrointestinal adverse reactions.

Topics: Aged; Alendronate; Alkaline Phosphatase; Bone Density; Bone Density Conservation Agents; Calcifediol; Calcium; Cholecalciferol; Drug Therapy, Combination; Exercise; Female; Femur; Humans; Lumbar Vertebrae; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Parathyroid Hormone; Phosphorus; Retrospective Studies; Vitamin D

Bisphosphonates like risedronate inhibit osteoclast-mediated bone resorption and are therefore used in the prevention and treatment of osteoporosis. Also vitamin D

Topics: Animals; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Disease Models, Animal; Female; Humans; Mice; Osteoporosis, Postmenopausal; Risedronic Acid; Vitamins

Elevations in serum Parathyroid Hormone (PTH) levels after denosumab administration have been described in medical literature among patients with renal impairment or intestinal malabsortion syndromes.. To present a case of denosumab-induced normocalcemic hyperparathyroidism in a woman with postmenopausal osteoporosis without renal impairment or malabsorption syndrome.. A 62-year-old woman was diagnosed with postmenopausal osteoporosis (serum iPTH: 61pg/mL) and received anti-osteoporotic medication (70mg alendronate sodium once weekly and 1g/800IU calcium carbonate/cholecalciferol daily). Because of severe gastrointestinal symptoms, the alendronate sodium was discontinued and replaced it with denosumab 60mg/mL subcutaneously. Three months after first receiving denosumab, the serum iPTH, 25[OH]D and calcium levels were 1350pg/mL, 24.8ng/ml and 8.4mg/dL, respectively. This dramatic elevation of serum iPTH was attributed to receiving denosumab, as other causes of normocalcemic hyperparathyroidism were excluded. So, an interruption of denosumab for the second semester and reception only 2g/1600IU calcium carbonate/cholecalciferol daily was decided. Twelve months later the serum iPTH, 25[OH]D and calcium levels were 71pg/mL, 33.2ng/ml and 9.4mg/dL, respectively.. A close monitoring of all patients prior to and during treatment with denosumab is suggested.

Topics: Bone Density Conservation Agents; Calcium; Calcium Carbonate; Cholecalciferol; Denosumab; Female; Humans; Hyperparathyroidism; Kidney Function Tests; Middle Aged; Osteoporosis, Postmenopausal; Parathyroid Hormone

Recent pooled analyses have shown that strontium ranelate increases the incidence of venous thromboembolism and non-fatal myocardial infarction, but no explanations were given. The aim of our study was to assess the effects a 12-month treatment with strontium ranelate on hemostasis factors and markers of cardiovascular risk in postmenopausal osteoporotic women. Forty osteoporotic postmenopausal women received orally strontium ranelate 2 g daily, plus calcium and colecalcipherol for 12 months. Forty postmenopausal osteopenic women matched for age, menopausal age, and body mass index served as controls and received orally calcium and colecalcipherol for 12 months. Biochemical cardiovascular risk factors and hemostatic indices were assayed prior to treatment, and after 3, 6, and 12 months of therapy. These indices included fibrinogen, fasting glucose, total serum cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, plasma levels of D-dimer, homocysteine, partial thromboplastin time, and prothrombin time. In addition, we evaluated possible changes in blood pressure and occurrence of venous thromboembolic events. At baseline, no statistically significance was observed between the two groups except for bone mineral density at lumbar spine, femoral neck, and total femur, which was lower in strontium ranelate group. After 12 months of treatment, there was no statistically significant change in cardiovascular risk factors and hemostatic parameters. None of the 40 women developed any clinical venous thromboembolic event. A 12-month treatment with strontium ranelate did not alter hemostasis factors or markers of cardiovascular risk, suggesting that reported increased risk of venous thromboembolism and myocardial infarction with strontium is mediated by other factors.

Topics: Aged; Blood Pressure; Bone Density; Bone Density Conservation Agents; Calcium; Cardiovascular Diseases; Cholecalciferol; Cholesterol; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Postmenopause; Prothrombin Time; Risk Factors; Thiophenes; Treatment Outcome

To assess the effect of active vitamin D3 on quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis.. This is a post hoc analysis of a previous prospective postmarketing observational study conducted without a comparator group. This study was conducted in 60 Japanese hospitals from September 2007 to February 2009. We compared changes from baseline in QOL and pain in patients receiving raloxifene plus active vitamin D3 with those in patients receiving raloxifene monotherapy at 8 and 24 weeks after treatment.. Japan Pharmaceutical Information Center (JapicCTI-070465).. QOL and pain were assessed using Short Form-8 (SF-8), European Quality of Life Instrument 5 Dimensions (EQ-5D), Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), visual analogue pain scales (VAS pain), and pain frequency scores.. A total of 506 patients were included in the post hoc analysis. Both raloxifene monotherapy (RLX, n = 354) and active vitamin D3 cotreatment (COMBI, n = 152) significantly improved QOL and reduced pain from the baseline at Week 8 and Week 24. The COMBI group had significantly greater improvements in JOQOL total score and activity of daily living (total) domain at Week 24 and last observation carried forward (LOCF) than the RLX group. The COMBI group also had significantly greater improvements in SF-8 domains of general health (at Week 8, Week 24, and LOCF), role physical (at Week 24 and LOCF), and mental health (at LOCF) than the RLX group. The COMBI group also had significantly greater reduction in VAS pain at LOCF than the RLX group (mean [SD]: RLX = -0.99 [2.72], COMBI = -1.54 [2.21], P = 0.042).. Active vitamin D3 supplementation to raloxifene treatment for 24 weeks may have additional benefits in improving QOL and relieving pain in Japanese women with postmenopausal osteoporosis.

Topics: Aged; Bone Density Conservation Agents; Cholecalciferol; Drug Therapy, Combination; Female; Humans; Japan; Middle Aged; Osteoporosis, Postmenopausal; Pain; Pain Measurement; Product Surveillance, Postmarketing; Prospective Studies; Quality of Life; Raloxifene Hydrochloride; Surveys and Questionnaires

Substantial variability exists in the serum 25(OH)D increase observed in response to vitamin D supplementation. Measurement of circulating cholecalciferol and 24,25(OH)₂D, as indicators of vitamin D absorption and degradation, respectively, account for approximately half of the variation in serum 25(OH)D observed following supplementation.. Vitamin D supplementation produces a variable response in serum 25(OH)D. This variability likely reflects, in part, differences in vitamin D absorption and/or degradation. Despite this variation in response, virtually all expert recommendations endorse a fixed vitamin D supplementation dose, an approach also used in most prospective studies. Such utilization of a single vitamin D dose does not assure attaining any pre-specified target 25(OH)D level, thereby compromising clinical care and prospective supplementation trials. This study begins addressing this weakness by exploring the feasibility of vitamin D metabolite measurements to predict serum 25(OH)D level attained following supplementation.. Ninety-one community-dwelling postmenopausal women with baseline 25(OH)D of 10-30 ng/mL received oral vitamin D₃, 2300 or 2500 IU, daily for 4-6 months. Serum 25(OH)D, cholecalciferol (D₃), and 24,25(OH)₂D were measured before and at the end of supplementation to determine if metabolite concentrations allow prediction of the 25(OH)D level attained.. From baseline and follow-up data, we derived a multiple linear regression model predicting posttreatment 25(OH)D as follows: final 25(OH)D = 8.3 + (1.05*initial 25(OH)D) - (7.7*initial 24,25(OH)₂D) + (0.53*final D₃) + (4.2*final 24,25(OH)₂D). This model has an adjusted R(2) = 0.55, thus accounting for approximately half of the observed variance in the final 25(OH)D level.. The contributions of circulating cholecalciferol and 24,25(OH)₂D to this predictive model can be considered as indicators of intestinal absorption and clearance, respectively. This paradigm requires further study; it may allow efficient "treat-to-25(OH)D-target" strategies useful in optimizing prospective studies and clinical practice.

Topics: 24,25-Dihydroxyvitamin D 3; Aged; Bone Density Conservation Agents; Cholecalciferol; Dietary Supplements; Drug Monitoring; Female; Follow-Up Studies; Humans; Middle Aged; Osteoporosis, Postmenopausal; Vitamin D

Secondary osteoporosis occurs in many diseases. Celiac disease-induced osteoporosis is the consequence of secondary hyperparathyroidism. Biochemical bone markers show predominance of bone resorption, thus making the bisphosphonates the first line therapy option. Intestinal mucosal changes are reversible on gluten-free diet. Osteoporosis reversibility is also possible, provided postmenopausal osteoporosis risk factors independent from celiac disease are not present.. We presented a postmenopausal woman with at least a 10-year history of celiac disease prior to diagnosis, which had overt secondary hyperparathyroidism with insufficient status of vitamin D and a significant bone mass reduction. At the time of diagnosis of celiac disease the patient was receiving 250 μg of levothyroxine daily without achieving optimal substitution. Three years after the initiation of gluten-free diet the patient was without any signs and symptoms of the disease. All laboratory findings were within normal range. It was decided to treat the underlying disease and to supplement calcium and vitamin D without the initiation of bisphosponate therapy.. Osteoporosis regression justified this therapeutic approach. The presence of primary autoimmune hypothyroidism makes this case specific, since the inability for optimal substitution therapy with a high daily dose of levothyroxine provoked the suspicion of celiac disease.

Topics: Calcium; Celiac Disease; Cholecalciferol; Diet, Gluten-Free; Female; Humans; Hyperparathyroidism, Secondary; Middle Aged; Osteoporosis, Postmenopausal; Thyroxine; Vitamin D; Vitamin D Deficiency

Fragility fractures are a major burden for health and social care in elderly people. In order to identify earlier the "frail elders", new concepts of "dysmobility syndrome" and skeletal muscle function deficit (SMFD), including sarcopenia, osteoporosis, obesity, and mobility limitation, leading to a higher risk of fractures, have been recently introduced. There are very few studies investigating the association between fragility fractures and both the dysmobility syndrome and the SMFD.. The objective of our study is to investigate the role of previous fragility fractures as a risk factor in determining the dysmobility syndrome and/or the SMFD in post-menopausal women.. In this case-control study, we retrospectively examined data from the medical records of post-menopausal women aged 50 or older. We divided the study population in two groups. The first group includes women with a previous fragility fracture (cases) and the other group includes women without any previous osteoporotic fracture (controls). We identified the subjects with "dysmobility syndrome", "dynapenic SMFD", "sarcopenic SMFD", and "mixed SMFD" in both groups. Data collected refer to a 6-month period.. We retrieved data of 121 post-menopausal women, 77 (63.64%) had already sustained a fragility fracture at any site (cases). The risk for dysmobility syndrome was significantly higher (adjusted OR for age and serum 25-OH vitamin D3 of 2.46) in the cases compared with the controls.. An early diagnosis of conditions limiting mobility, including dysmobility syndrome, might be useful to identify, among patients with osteoporotic fractures, those who might have a higher risk of a new fragility fracture.

Topics: Aged; Aged, 80 and over; Bone Density; Case-Control Studies; Cholecalciferol; Female; Frail Elderly; Humans; Italy; Mobility Limitation; Muscle Weakness; Muscle, Skeletal; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Prevalence; Risk Assessment; Risk Factors; Sarcopenia; Syndrome

Strontium ranelate is used to treat osteoporosis. Calcium (Ca) and strontium (Sr) have common chemical features and are absorbed by the same pathways. Vitamin D has a main role in calcium intestinal absorption. The aim of this study was to investigate whether vitamin D status is a determinant of strontium ranelate absorption.. Twenty-five patients with vitamin D deficiency (25(OH)D<50 nmol/l) and 25 with vitamin D sufficiency (25(OH)D>75 nmol/l) underwent a 4-h oral Sr overload test. Sr absorption was evaluated as the fraction of absorbed dose and the area under the curve. After the baseline overload test, the deficient patients were treated until reaching sufficient vitamin D levels (25(OH)D>75 nmol/l) and the test was repeated.. Changing vitamin D status from deficient to sufficient resulted in a significant increase in 1,25(OH)2D (24.97±4.64×34.62±9.14 pg/ml, P<0.001) and a reduction in parathyroid hormone (73.87±37.50×58.24±20.13 pg/ml, P=0.006). Nevertheless, no differences were found in the parameters used to evaluate Sr absorption between the vitamin D deficient and sufficient groups. In addition, vitamin D3 replacement in the deficient group did not result in enhanced Sr absorption.. Vitamin D status did not interfere with strontium ranelate absorption. Taking into account the benefits of adequate vitamin D status in osteoporotic patients, we strongly recommend the treatment of vitamin D deficiency. However, the data demonstrate that such treatment does not enhance strontium ranelate absorption in patients with mild deficiency.

Topics: Aged; Area Under Curve; Bone Density Conservation Agents; Calcium; Case-Control Studies; Cholecalciferol; Female; Humans; Intestinal Absorption; Middle Aged; Osteoporosis, Postmenopausal; Prospective Studies; Thiophenes; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Humans; Intestinal Absorption; Nutritional Requirements; Osteoporosis, Postmenopausal

Topics: Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Humans; Intestinal Absorption; Nutritional Requirements; Osteoporosis, Postmenopausal

Topics: Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Humans; Intestinal Absorption; Nutritional Requirements; Osteoporosis, Postmenopausal

The mechanisms regulating the anabolic response of the skeleton for recombinant human PTH (1- 34) [rhPTH (1-34)] administration has not been fully elucidated.. The aim of this study was to evaluate the effect of rhPTH (1-34) on serum levels of runt-related transcription factor 2 (Runx2) in women with osteoporosis.. Sixty post-menopausal women with osteoporosis (EO group) and 45 control subjects (NC group) were enrolled in this study. The EO group received daily injection of 20 μg rhPTH (1-34) plus oral 500 mg elemental calcium and 400 IU vitamin D3 for 6 months. Runx2 and Matrix metalloproteinase 13 (MMP-13) were measured with commercially available enzyme-linked immunosorbent assay kits. Bone mineral density (BMD) was also measured before and 6 months after rhPTH (1-34) treatment.. Serum total Ca2+, phosphate, and bone-specific alkaline phosphatase were significantly increased (p<0.05 or p<0.01), and the lumbar spine BMD (LS-BMD) was also increased by 4% in patients with osteoporosis after treatment with rhPTH (1-34) (p<0.05). On the contrary, serum Runx2 and MMP-13 were significantly decreased at post treatment (13.1% and 36.6%, respectively, p<0.05 and p<0.01). At baseline, serum Runx2 positively correlated with MMP-13 (r=0.74, p<0.01), the correction remained after adjusting for age and body mass index.. The daily injection of rhPTH (1-34) was able to stimulate bone formation. The therapy of 20 μg rhPTH (1- 34) for 6 months resulted in decrease of serum Runx2 and MMP-13. These changes might reflect the increase of active osteoblasts and the better bone homeostasis.

Topics: Alkaline Phosphatase; Biomarkers; Bone Density; Case-Control Studies; Cholecalciferol; Core Binding Factor Alpha 1 Subunit; Enzyme-Linked Immunosorbent Assay; Female; Humans; Matrix Metalloproteinase 13; Middle Aged; Osteogenesis; Osteoporosis, Postmenopausal; Parathyroid Hormone; Postmenopause; Recombinant Proteins; Time Factors

Topics: Bone Density; Cholecalciferol; Dietary Supplements; Female; Humans; Osteoporosis, Postmenopausal

Lifetime supplementation with vitamin K, vitamin D(3), and calcium is likely to reduce fractures and increase survival in postmenopausal women. It would be a cost-effective intervention at commonly used thresholds, but high uncertainty around the cost-effectiveness estimates persists. Further research on the effect of vitamin K on fractures is warranted.. Vitamin K might have a role in the primary prevention of fractures, but uncertainties about its effectiveness and cost-effectiveness persist.. We developed a state-transition probabilistic microsimulation model to quantify the cost-effectiveness of various interventions to prevent fractures in 50-year-old postmenopausal women without osteoporosis. We compared no supplementation, vitamin D(3) (800 IU/day) with calcium (1,200 mg/day), and vitamin K(2) (45 mg/day) with vitamin D(3) and calcium (at the same doses). An additional analysis explored replacing vitamin K(2) with vitamin K(1) (5 mg/day).. Adding vitamin K(2) to vitamin D(3) with calcium reduced the lifetime probability of at least one fracture by 25%, increased discounted survival by 0.7 quality-adjusted life-years (QALYs) (95% credible interval (CrI) 0.2; 1.3) and discounted costs by $8,956, yielding an incremental cost-effectiveness ratio (ICER) of $12,268/QALY. At a $50,000/QALY threshold, the probability of cost-effectiveness was 95% and the population expected value of perfect information (EVPI) was $28.9 billion. Adding vitamin K(1) to vitamin D and calcium reduced the lifetime probability of at least one fracture by 20%, increased discounted survival by 0.4 QALYs (95% CrI -1.9; 1.4) and discounted costs by $4,014, yielding an ICER of $9,557/QALY. At a $50,000/QALY threshold, the probability of cost-effectiveness was 80% while the EVPI was $414.9 billion. The efficacy of vitamin K was the most important parameter in sensitivity analyses.. Lifetime supplementation with vitamin K, vitamin D(3), and calcium is likely to reduce fractures and increase survival in postmenopausal women. Given high uncertainty around the cost-effectiveness estimates, further research on the efficacy of vitamin K on fractures is warranted.

Topics: Bone Density Conservation Agents; Calcium; Canada; Cholecalciferol; Cost-Benefit Analysis; Dietary Supplements; Drug Costs; Drug Therapy, Combination; Female; Health Care Costs; Humans; Middle Aged; Models, Econometric; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Quality of Life; Quality-Adjusted Life Years; Treatment Outcome; Vitamin K 1; Vitamin K 2

Chronic alcohol abuse results in decreased bone mineral density (BMD), which can lead to increased fracture risk. In contrast, low levels of alcohol have been associated with increased BMD in epidemiological studies. Alcohol's toxic skeletal effects have been suggested to involve impaired vitamin D/calcium homeostasis. Therefore, dietary vitamin D supplementation may be beneficial in reducing bone loss associated with chronic alcohol consumption. Six-week-old female C57BL/6J mice were pair-fed ethanol (EtOH)-containing liquid diets (10 or 36% total calories) for 78 days. EtOH exposure at 10% calories had no effects on any measured bone or serum parameter. EtOH consumption at 36% of calories reduced BMD and bone strength (P<0.05), decreased osteoblastogenesis, increased osteoclastogenesis, suppressed 1,25-hydroxyvitamin D3 [1,25(OH)2D3] serum concentrations (P<0.05), and increased apoptosis in bone cells compared with pair-fed controls. In a second study, female mice were pair-fed 30% EtOH diets with or without dietary supplementation with vitamin D3 (cholecalciferol; VitD) for 40 days. VitD supplementation in the EtOH diet protected against cortical bone loss, normalized alcohol-induced hypocalcaemia, and suppressed EtOH-induced expression of receptor of nuclear factor-κB ligand mRNA in bone. In vitro, pretreatment of 1,25(OH)2D3 in osteoblastic cells inhibited EtOH-induced apoptosis. In EtOH/VitD mice circulating 1,25(OH)2D3 was lower compared with mice receiving EtOH alone (P<0.05), suggesting increased sensitivity to feedback control of VitD metabolism in the kidney. These findings suggest dietary VitD supplementation may prevent skeletal toxicity in chronic drinkers by normalizing calcium homeostasis, preventing apoptosis, and suppressing EtOH-induced increases in bone resorption.

Topics: Animals; Apoptosis; Biomechanical Phenomena; Body Composition; Body Weight; Bone Density; Bone Marrow; Bone Remodeling; Cells, Cultured; Central Nervous System Depressants; Cholecalciferol; Ethanol; Female; Femur; Gene Expression; Humans; Mice; Mice, Inbred C57BL; Osteoblasts; Osteoclasts; Osteoporosis, Postmenopausal; RNA; Tomography, X-Ray Computed; Vitamin D; Vitamins; Weight Gain

Bisphosphonates increase bone mineral density (BMD) and also increase parathyroid hormone (PTH): the rule of increased PTH on BMD is not well known. The aim of our study was to assess the relationship between endogenous PTH levels and BMD after 18 months of antiresorptive therapy in a group of post-menopausal women with normal baseline PTH levels.. A retrospective study was conducted on 62 women with normal baseline PTH levels (mean age 62.7 ± 8.6 years) who underwent dual-energy X-ray absorptiometry, thoracic-lumbar radiography, and blood and urine sampling at the baseline and after 18 months. All patients were treated with bisphosphonates and received calcium and vitamin D3 supplementation.. In the whole group, after 18 months, mean BMD improved both at lumbar spine (0.53 ± 0.09 vs. 0.49 ± 0.09 g/cm2; P<0.05) and at femur (0.66 ± 0.08 vs. 0.65 ± 0.09 g/cm2; P<0.05); PTH levels (56.80 ± 19.07 vs. 48.74 ± 14.99 pg/mL; P<0.001) and serum 25-hydroxyvitamin D (60.73 ± 29.87 vs. 49.81 ± 26.56 ng/mL; P<0.05) increased. Dividing the patients according PTH variation (>0 or ≤ 0), the group with ΔPTH>0 had higher percentage increase of BMD at spine (8.0 ± 9% vs. 4 ± 7.5%; P<0.001) and at total hip (3 ± 9% vs. 0.49 ± 8.9%; P<0.001) while the bone alkaline phosphatase significantly decreased (-11.80 ± 2.19 vs. -4.05 ± 3.08 ug/L; P<0.001) than the other group.. Increased endogenous PTH levels seems to be associated with a higher BMD increase in patients treated with bisphosphonates for postmenopausal osteoporosis. The increase of PTH must be clarified by further investigations.

Topics: Absorptiometry, Photon; Aged; Alkaline Phosphatase; Bone and Bones; Bone Density; Bone Density Conservation Agents; Calcium; Cholecalciferol; Dietary Supplements; Diphosphonates; Female; Hip Joint; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis, Postmenopausal; Parathyroid Hormone; Retrospective Studies; Thoracic Vertebrae; Time Factors; Treatment Outcome; Up-Regulation; Vitamin D

Suboptimal vitamin D status is common in elderly individuals. However, the extent of vitamin D inadequacy in men and women being treated for osteoporosis in a family practice setting has not been well characterized.. To describe the distribution of serum 25-hydroxyvitamin D (25-[OH] D) in Canadian men and postmenopausal women with osteoporosis taking 400 IU or less of vitamin D daily and to evaluate the safety, tolerability, and impact of vitamin D(3) supplementation 400 IU daily taken concurrently with alendronate sodium 70 mg weekly.. This was a prospective, single-cohort, open-label, multicenter study. Community-dwelling men and postmenopausal women with osteoporosis were recruited at 197 sites across Canada. Patients received vitamin D(3) 400 IU/day supplementation coadministered with alendronate 70 mg/wk for 16 weeks. The primary outcome was the distribution of serum 25-(OH) D at baseline. Secondary outcome measures included changes from baseline in serum 25-(OH) D levels, adherence to study treatments, and incidence of treatment-related adverse events (AEs).. Of the 681 patients included in the analysis, 485 (71.2%) completed the study. Patients were predominantly female (83.1%) with a mean (SD) age of 67.6 (10.7) years. At baseline, mean (SD) serum 25-(OH) D concentration was 25.4 (9.9) ng/mL and 68.0% of the patients had inadequate (less than 30 ng/mL) vitamin D status. At week 16, concentrations increased by 35.1% to 31.2 (9.2) ng/mL (p < 0.001) and the proportion of patients with inadequate 25-(OH) D levels was reduced to 47.0%. Adherence to the treatment regimen was high (greater than 95%). Gastrointestinal disorders were the most frequently reported (6.9%) treatment-related AEs.. About two thirds of patients previously diagnosed with osteoporosis have inadequate vitamin D status. A treatment regimen consisting of alendronate 70 mg/wk administered with daily vitamin D(3) 400 IU supplementation significantly increased patients' serum 25-(OH) D levels, but 47% did not achieve optimal levels. These results support both the National Osteoporosis Foundation and Osteoporosis Canada recommendations for higher vitamin D supplement doses (at least 800 IU daily) in osteoporotic patients receiving pharmacologic therapy for osteoporosis and for monitoring their serum 25-(OH) D response.

Topics: Aged; Alendronate; Bone Density Conservation Agents; Canada; Cholecalciferol; Cohort Studies; Dietary Supplements; Female; Humans; Male; Osteoporosis; Osteoporosis, Postmenopausal; Prospective Studies; Treatment Outcome; Vitamin D

In patients with primary hyperparathyroidism (PHPT) not suitable for surgical correction, a skeletal protection with bisphosphonates is considered a reasonable option, but the long-term effects after treatment discontinuation are not well known. Sixty postmenopausal women with PHPT were given 400-600 IU vitamin D(3) daily and 100 mg neridronate IV every 2 months for 2 years with 2 additional years of follow-up without antiresorptive therapies. Bone mineral density (BMD) progressively rose by 6.7 ± 7.6% (SD) and by 2.9 ± 4.5% at the spine and femoral neck, respectively. During follow-up, mean BMD progressively fell, but after 2 years it was still 3.9 ± 5.5% higher than baseline values at the spine. Bone alkaline phosphatase and serum C-telopeptide of type I collagen decreased significantly within 6 months (28 and 49% versus baseline, respectively) and rose to baseline values within 6-12 months during follow-up. Serum PTH significantly rose from baseline during treatment, but it remained significantly higher than baseline during follow-up. The PTH changes were significantly correlated with serum 25-hydroxyvitamin D (25OHD) levels. In conclusion, in this study we observed that in patients with mild PHPT treatment with bisphosphonates is associated with the expected changes in bone-turnover markers and that the significant increases of both hip and spine BMD are partially maintained for at least 2 years after treatment discontinuation at the vertebral site. The marked increases in serum PTH levels, particularly in subjects with low 25OHD levels, persist after treatment discontinuation and this raises the suspicion that this might reflect a worsening of PHPT.

Topics: Aged; Alkaline Phosphatase; Bone Density Conservation Agents; Cholecalciferol; Collagen Type I; Diphosphonates; Female; Femur Neck; Humans; Hyperparathyroidism, Primary; Middle Aged; Osteoporosis, Postmenopausal; Parathyroid Hormone; Peptides; Time

Topics: Bone Density; Bone Diseases, Metabolic; Cholecalciferol; Cohort Studies; Comorbidity; Dietary Supplements; Disease Progression; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Postmenopause; Prevalence; Scleroderma, Systemic; Spain; Vitamin D; Vitamin D Deficiency

Hip fracture occurrences in nursing homes are associated with high morbidity, mortality, and high health care costs in elderly people. In the United States, approximately 340,000 hip fractures occur each year, while more then 90% are associated with falls. Osteoporosis is a skeletal disorder causing impaired bone strength that increases the risk of fracture. In the United States alone, osteoporosis affects < 10 million individuals aged > or =50. The American Association of Clinical Endocrinologists (AACE), North American Menopause Society (NAMS), and National Osteoporosis Foundation (NOF) have developed recommendations for the identification of patients with osteoporosis who need therapy. Good nutrition with adequate supplements of calcium and vitamin D3 is considered one of the most important lifestyle factors for maintaining adequate bone mineral density. Only a combination of calcium and vitamin D therapy has been shown to increase the bone mineral density as well as a reduction in the nonvertebral fractures.

Topics: Accidental Falls; Aged; Aged, 80 and over; Bone Density; Bone Density Conservation Agents; Calcium; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Drug Therapy, Combination; Female; Health Care Costs; Hip Fractures; Homes for the Aged; Hospitalization; Humans; Male; Nursing Homes; Osteoporosis, Postmenopausal; Vitamin D Deficiency

Topics: Alendronate; Bone Density Conservation Agents; Calcium; Cholecalciferol; Clinical Trials as Topic; Drug Therapy, Combination; Etidronic Acid; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Patient Compliance; Risedronic Acid; Time Factors

In patients with monoclonal gammopathy of undetermined significance (MGUS) the increase of bone turnover rate can increase the risk of fracture. Thus, a treatment normalizing this negative balance could be of benefit in these patients. We studied 100 patients affected by MGUS, grouped according to the presence (group A, 50 patients) or absence (group B) of vertebral fractures and/or osteoporosis. Group A was treated with alendronate (70 mg/weekly) plus calcium and cholecalciferol for 18 months, and group B was treated with calcium and cholecalciferol. After 18 months, the mean bone mineral density (BMD) of the lumbar spine and total femur had increased by 6.1% and 1.5%, respectively, in group A. In the nine patients of this group not taking alendronate, BMD values of the lumbar spine and total femur decreased by 1.6% (P < or = 0.001 ) and 1.3% (P < or = 0.01), respectively. In patients of group B, BMD increased by 1.2% at the lumbar spine and decreased by 1.2% at the total femur. Corresponding figures of those patients in the same group not taking calcium and vitamin D supplementation were -0.1% and -1.2%, respectively. At 18 months we observed significant decreases of serum bone markers: the difference between the groups was -23.2 (P < or = 0.01) for bone alkaline phosphatase, -23.6 for osteocalcin (P < or = 0.01), -35.1 for C-terminal telopeptides of collagen type I (P < or = 0.001), and -0.47 for bone sialoprotein (P = nonsignificant). Treatment with alendronate could lead to a significant reduction in fracture risk in MGUS patients with skeletal fragility.

Topics: Alendronate; Alkaline Phosphatase; Biomarkers; Bone Density; Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Collagen Type I; Drug Therapy, Combination; Female; Femur; Humans; Lumbar Vertebrae; Male; Middle Aged; Monoclonal Gammopathy of Undetermined Significance; Osteocalcin; Osteopontin; Osteoporosis, Postmenopausal; Peptides; Radiography; Spinal Fractures

The purpose of the study was to determine the effect of long-term exercise on coronary heart disease, osteoporotic risk factors, and physical fitness parameters in postmenopausal women. Forty early postmenopausal women (age 55.1 +/- 3.3 years) with no medication or illness affecting bone metabolism exercised (high impact aerobic, multilateral jumps, multi-set resistance exercise) for 50 months (EG), while 28 women (age 55.5 +/- 3.0 years) served as a nontraining control (CG). Both groups were supplemented with calcium and cholecalciferol. Bone mineral density (BMD) was measured at the lumbar spine, hip, and forearm by dual energy x-ray absorptiometry. Blood lipids were determined using serum samples, and body composition was determined using the bioimpedance technique. Further, maximum isometric strength was determined (Schnell M3, Schnell Trainer). The BMD at the lumbar spine (+1.0%, p = 0.037) and the total hip (-0.3%, p = 0.194) were maintained in the EG, while significant (p < 0.001) decreases were observed in the CG (lumbar spine -3.2; total hip -2.3%). Differences between both groups were significant (p < 0.001). Significant differences between EG and CG were also observed, respectively, for total cholesterol (-6.1 vs. +3.5%, p = 0.008), HDL-cholesterol (+14.1 vs. -7.1%, p = 0.007), triglycerides (-10.2 vs. +27.5%, p = 0.002), body fat (-3.3 vs. +1.3%, p = 0.041), and waist-hip-ratio (-3.5 vs. +0.2%, p > 0.001). Maximum isometric strength significantly (p < 0.001) increased in the EG, while strength parameters decreased in the CG (-0.5 to -6.4%). Thus, the study demonstrated that multipurpose high-intensity exercise programs significantly affect relevant menopausal risk factors and, therefore, may be individually considered as an alternative to hormone replacement therapy.

Topics: Absorptiometry, Photon; Body Composition; Bone Density; Calcium; Cholecalciferol; Exercise; Female; Germany; Humans; Lipids; Menopause; Middle Aged; Osteoporosis, Postmenopausal; Physical Fitness; Risk Factors

Vitamin D is essential for intestinal calcium absorption, bone mineralisation and plays an important role in neuromuscular functions. Vitamin D insufficiency is highly prevalent among postmenopausal women with osteoporosis and in the elderly. In turn, supplements of vitamin D3 (cholecalciferol), and to a lesser extent vitamin D2 (ergocalciferol), may decrease falls and fracture risk by 25%. Despite some recent negative studies, the actual question is not to know whether vitamin D is necessary, but rather how much vitamin D is sufficient to prevent secondary hyperparathyroidism, falls and fractures. Moreover, the risk of osteoporosis and of fragility fractures may be influenced by genetic variation in the vitamin D receptor (VDR).

Topics: Accidental Falls; Aged; Bone Density Conservation Agents; Calcification, Physiologic; Calcium; Cholecalciferol; Ergocalciferols; Female; Fractures, Bone; Humans; Hyperparathyroidism, Secondary; Intestinal Absorption; Neuromuscular Junction; Osteoporosis; Osteoporosis, Postmenopausal; Receptors, Calcitriol; Vitamin D; Vitamins

Topics: Aged; Aged, 80 and over; Back Pain; Calcium; Cholecalciferol; Diagnosis, Differential; Diphosphonates; Dose-Response Relationship, Drug; Female; Fractures, Compression; Fractures, Spontaneous; Humans; Lumbar Vertebrae; Osteomalacia; Osteoporosis, Postmenopausal; Radiography

Vitamin D (colecalciferol) is critically important for the development, growth, and maintenance of a healthy skeleton from birth until death. Vitamin D is metabolized in the liver to 25-hydroxy-colecalciferol and then in the kidney to 1 alpha,25-dihydroxy-colecalciferol (calcitriol). Calcitriol is the dominant D(3)-hormone and produces a wide array of bio-logical responses via interacting both with the classical vitamin D nuclear receptor (VDR(nuc)) that regulates gene transcription in over 30 target organs and with a putative cell membrane receptor (VDR(mem1,25)) that mediates rapid biological responses. 24R,25-Dihydroxy-colecalciferol has been shown to be an essential D(3)-hormone for the process of bone fracture healing. It initiates its biological responses via stereospecific binding to a second cell membrane receptor, the VDR(mem24,25). The key D(3)-hormone involved in the regulation of cell proliferation in the prostate is 25-hydroxy-colecalciferol. It is mainly acting directly through the nuclear vitamin D receptor but partially also through its 1 alpha-hydroxylation in the prostate. Elderly subjects often have mean 25-hydroxy-colecalciferol levels in the insufficiency range throughout the year. The oral dose necessary to achieve adequate serum 25-hydroxy-colecalciferol levels is a daily dose of 400 IU.

Topics: Aged; Aged, 80 and over; Bone Density Conservation Agents; Calcitriol; Cholecalciferol; Female; Food Analysis; Humans; Male; Middle Aged; Osteoporosis, Postmenopausal; Prodrugs; Receptors, Calcitriol; Vitamin D; Vitamin D Deficiency

Although alendronate treatment for the prevention of osteoporotic fracture has been considered to be first line treatment, there is little knowledge whether very old osteoporosis should be treated with alendronate or not. To elucidate this question, we investigated the effectiveness of osteoporotic drugs in terms of effects of treatment on bone mineral density (BMD), bone resorption markers and fracture prevention in osteoporosis aged over 75 years old or less. A total of 1,041 postmenopausal osteoporosis cases were classified into 4 categories, Young controls (n = 165) and Old controls (n = 95) (Control group), Young (n = 309) and Old osteoporosis (n = 110) treated with alendronate (ALN group), and Young (n = 238) and Old osteoporosis (n = 124) treated with vitamins D3 or K2 (VDK group). We followed their lumbar BMD, urinary excretion of NTX and incident vertebral fracture rate for three years. The effects of the ALN treatment on lumbar BMD and on urinary NTX were not different between the two age-categorized osteoporosis groups, namely, the lumbar BMD increased by around 6-7% after ALN treatment in both Old and Young groups. The urinary excretion of NTX was decreased by 50% from baseline in both Old and Young ALN treated groups. Those effects of ALN were significantly superior to those in the controls and VDK-treated groups of both age categories. Therefore, ALN biological effects on bone were not age-dependent and the effects of ALN were strongest than the other treatments. The effects on fracture prevention in the Old ALN-treated group showed a 66.7% risk reduction rate (RRR) (p< 0.05) when the fracture incidence rate in the control group (50%) was taken as 100%, while it was 18.8% RRR (ns) in VDK-treated Old group. The Young group treated with ALN showed a 35.6% RRR from the Young control group (25% as 100%) (p<0.05). The VDK treated group did not show a significant RRR of incident fracture (24.4%). Thus, alendronate was the only effective modality to prevent fractures in both young and old osteoporosis. These results clearly indicated that very old osteoporotics should be treated with alendronate at this moment.

Topics: Age Factors; Aged; Aged, 80 and over; Alendronate; Bone Density; Bone Density Conservation Agents; Bone Resorption; Cholecalciferol; Cohort Studies; Female; Follow-Up Studies; Humans; Osteoporosis, Postmenopausal; Retrospective Studies; Spinal Fractures; Vitamin K 2

In postmenopausal osteoporosis, the administration of alfacalcidol to women resulted in an increase in trabecular bone mineral density (BMD), prevention of cortical bone loss, and a significant reduction in the incidence of further vertebral fractures. There is now robust evidence that alfacalcidol may be particularly active in conditions characterized by an increased rate of bone loss. Alfacalcidol 1 microg/day fully prevented vertebral bone loss over 3 years in women after the first year of menopause. In a large cohort of individuals starting treatment with high dose corticosteroid (CS, 46.6 mg equivalent prednisolone per day), the spinal bone loss observed in untreated patients was fully prevented by administration of 1 microg/day alfacalcidol. In patients with established CS-induced osteoporosis, with or without prevalent vertebral fractures, 1 microg/day of alfacalcidol, given for 3 years, increased lumbar spine density, reduced back pain, and showed a significant reduction in the rate of new vertebral fractures, compared to native vitamin D. In cardiac transplant recipients, alfacalcidol and calcium reduced spinal and femoral bone loss, compared to a control group treated with etidronate and calcium. Alfacalcidol-treated patients experienced fewer new vertebral fractures over the 2-year followup. When alfacalcidol and vitamin D3 were compared in elderly women with radiologic evidence of vertebral fracture, fractional calcium absorption was increased after 3 months with alfacalcidol but was unchanged with vitamin D3. In a recent metaanalysis of 14 studies of native vitamin D and 19 studies of D-hormone analogs (alfacalcidol and calcitriol), the D-analogs exerted a higher preventive effect on bone loss and fracture rates in patients with no exposure to CS. In head-to-head studies comparing D-analogs and native vitamin D in patients receiving CS, this metaanalysis identified significant effects favoring D-analogs for femoral neck BMD and spinal fractures. In conclusion, improvement in bone turnover, increase in BMD, and reduction in fracture rates have been described during alfacalcidol treatment in situations characterized by a high rate of bone loss, including CS-induced osteoporosis, early postmenopausal bone loss, and organ transplant. Compared to plain vitamin D, alfacalcidol exerts higher bone-protective effects, thus allowing the doses to be minimized and lowering the risk of adverse effects, including hypercalcemia.

Topics: Adrenal Cortex Hormones; Animals; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Cholecalciferol; Clinical Trials as Topic; Female; Fractures, Bone; Humans; Hydroxycholecalciferols; Osteoporosis; Osteoporosis, Postmenopausal; Spinal Fractures; Transplantation

To assess the cost implications for a preventive treatment strategy for institutionalised elderly women with a combined 1200 mg/day calcium and 800 IU/day vitamin D(3) supplementation in seven European countries.. Retrospective cost effectiveness analysis based on a prospective placebo-controlled randomised clinical trial.. Recently published cost studies in seven European countries. Clinical results from Decalyos, a 3-year placebo-controlled study in elderly institutionalised women.. Decalyos study, with 36 months follow-up of 3270 mobile elderly women living in 180 nursing homes, allocated to two groups. One group received 1200 mg/day elemental calcium in the form of tricalcium phosphate together with 800 IU/day (20 microg) of cholecalciferol (vitamin D(3)), the other placebo.. In the 36 months analysis of the Decalyos study, 138 hip fractures occurred in the group of 1176 women, receiving supplementation and 184 hip fractures in the placebo group of 1127 women. The mean duration of treatment was 625.4 days. Adjusted to 1000 women, 46 hip fractures were avoided by the calcium and vitamin D(3) supplementation. For all countries, the total costs in the placebo group were higher than in the group receiving supplementation, resulting in a net benefit of 79000-711000 per 1000 women.. This analysis suggests that the supplementation strategy is cost saving. The results may underestimate the net benefits, as this treatment has also shown to be effective in decreasing the incidence of other non-vertebral fractures in elderly institutionalised women.

Topics: Aged; Calcium Phosphates; Cholecalciferol; Cost-Benefit Analysis; Drug Costs; Drug Therapy, Combination; Europe; Female; Health Care Costs; Hip Fractures; Humans; Osteoporosis, Postmenopausal

Topics: Age Factors; Aged; Alendronate; Calcium; Cholecalciferol; Diphosphonates; Drug Therapy, Combination; Evidence-Based Medicine; Female; Humans; Male; Meta-Analysis as Topic; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal; Practice Guidelines as Topic; Raloxifene Hydrochloride; Randomized Controlled Trials as Topic; Risk Factors; Selective Estrogen Receptor Modulators; Sex Factors

Topics: Aged; Aged, 80 and over; Calcium; Calcium, Dietary; Cholecalciferol; Female; Fractures, Spontaneous; Health Surveys; Humans; Middle Aged; Osteoporosis, Postmenopausal; Risk Factors; Vitamin D Deficiency

Negative mineral balance in postmenopausal women appears to be an important risk factor for osteoporosis and subsequent bone fractures. Its pathogenesis has not been elucidated.. To elucidate the participation of the kidney and ageing on mineral balance in postmenopausal women.. 36 postmenopausal women with osteopenia or osteoporosis, aged 46-75 years were evaluated by determination of mineral balance, kidney functions, 25(OH)-cholecalciferol [25(OH)D], 1,25(OH)2-cholecalciferol [1,25(OH)2D] and intact parathormone plasma levels.. Plasma calcium (Ca) concentrations were low and they did not decrease further with ageing. Urinary Ca excretion decreased (r = -0.425, p < 0.01) with age without changes in the fractional excretion of Ca. A similar decrease of urinary excretion was found in the urinary excretion of phosphorus (Pi) (r = -0.335; p < 0.03) and magnesium (Mg) (r = -0.355; p < 0.03). All patients' kidney functions were in the age-related reference range. Plasma 25(OH)D concentrations were in the range of moderate to severe deficiency, related inversely to age (r = -0.357; p < 0.03) and Ca urinary excretion (r = 0.343; p < 0.04) and to plasma creatinine concentration (r = 0.381; p < 0.02). Plasma 1,25(OH)2D concentrations were also low, they did not change with age and were highly correlated with Ca urinary excretion (r = 0.458; p < 0.005). The intact parathormone (iPTH) plasma concentrations were in the reference range, without any changes during aging.. Pi, Mg and dominantly Ca imbalance in postmenopausal women with osteopenia or osteoporosis accentuates with age and besides their insufficient intake the vitamin D deficiency takes part. These data support the need for increased supplementation of Ca and vitamin D with increasing age. (Tab. 3, Fig. 4, Ref. 18.).

Topics: Aged; Aging; Bone Density; Bone Diseases, Metabolic; Calcium; Cholecalciferol; Creatinine; Female; Humans; Kidney; Magnesium; Middle Aged; Osteoporosis, Postmenopausal; Phosphorus

Radio-Frequency-Tissue-Ablation (RFTA) for the treatment of primary and secondary tumours of the liver has been used for several years, but this minimally invasive treatment is not limited to the liver. A patient suffering from symptomatic postmenopausal osteoporosis, additionally having primary hyperparathyroidism since 1995, refused a surgical resection of the adenoma of the parathyroid gland. Sonographically a 16 mm hypoechoic tumour dorsal of the right upper pole of the thyroid gland was detected. Osteodensitometry: severe osteoporosis of the lumbar spine (88 % of the norm for this age group). Blood check: Elevation of serum calcium level (3.1mmol/l) and serum parathormone level 274 pg/dl (N: 10-50). A percutaneous ultrasound guided RFTA of the adenoma of the thyroid gland was carried out. After RFTA the serum parathormone levels and the serum calcium levels dropped back to normal. The patient was followed-up for one year. For the first time a sufficient therapy for osteoporosis comprising calcium, etidronate and cholecalciferol could be carried out. The osteodensitometry carried out one year after treatment showed an increase in bone density. For the treatment of symptomatic primary hyperparathyroidism RFTA can be a therapeutic alternative for patients with contraindications for surgery.

Topics: Adenoma; Aged; Bone Density; Calcium; Catheter Ablation; Cholecalciferol; Etidronic Acid; Female; Follow-Up Studies; Humans; Osteoporosis, Postmenopausal; Parathyroid Neoplasms; Thyroid Neoplasms; Time Factors; Treatment Outcome; Ultrasonography

Women experience rapid bone loss following menopause. Currently available guidelines recommend lifestyle counseling and pharmacotherapy for osteoporosis prevention and treatment in postmenopausal women.. We analyzed 2 years of National Ambulatory Medical Care Survey data (1997-1998), a national representative survey evaluating recent national patterns of antiosteoporosis medication (AOM) use and lifestyle counseling among office visits made by nonpregnant women 40 years and older.. Women 40 years and older made an estimated 267 million office visits annually. Of those visits, about 10% were associated with AOM therapy. Estrogen replacement therapy was the most prevalent form of AOM therapy (80%) followed by therapy with calcium and/or cholecalciferol (vitamin D) supplements (15%). Visits for AOM were more likely to be associated with women in their 50s and 60s, white race, and having private insurance or Medicare. Women at AOM visits were twice as likely to receive concurrent lifestyle counseling than women at visits without AOM therapy.. Women are particularly at risk for osteoporosis as they experience menopause, with estimates of 20 million women with osteoporosis or osteopenia. Despite the high prevalence, our study showed that only 10% of all visits were associated with 1 or more AOM therapy prescribed, provided, or continued in 1997 and 1998. These data also suggest that women with Medicaid or self-pay status were less likely to receive AOMs than women with other forms of insurance. The status of AOM therapy and lifestyle counseling in ambulatory care practice in the United States during 1997 and 1998 was less than optimal.

Topics: Adult; Aged; Aged, 80 and over; Ambulatory Care; Calcium; Cholecalciferol; Counseling; Estrogen Replacement Therapy; Female; Humans; Life Style; Middle Aged; Office Visits; Osteoporosis, Postmenopausal; Practice Patterns, Physicians'; United States

Topics: Aged; Australia; Cholecalciferol; Ergocalciferols; Female; Humans; Osteoporosis, Postmenopausal; Therapeutic Equivalency; Vitamin D Deficiency

Topics: Absorptiometry, Photon; Aged; Calcium, Dietary; Cholecalciferol; Diphosphonates; Exercise; Female; Fluorides; Fractures, Spontaneous; Humans; Osteoporosis, Postmenopausal; Raloxifene Hydrochloride; Risk Assessment

Topics: Accidental Falls; Aged; Bone Density; Calcium Gluconate; Calcium Phosphates; Cholecalciferol; Drug Combinations; Female; Humans; Osteoporosis, Postmenopausal

Topics: Alendronate; Bone Density; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Fractures, Bone; Humans; Osteoporosis, Postmenopausal

Black women have lower levels of serum 25-hydroxyvitamin D (25OHD) with higher serum PTH levels than white women. Correction of these alterations in the vitamin D-endocrine system could lead to less bone loss in postmenopausal women and, consequently, preservation of bone mass. Ten healthy postmenopausal black women were given 20 microg vitamin D3 daily for 3 months. At the end of the study, mean serum 25OHD levels had increased from 24 to 63 nmol/L. Serum intact PTH and nephrogenous cAMP declined significantly, and there was a 21% drop in the fasting urinary N-telopeptide of type I collagen. Vitamin D3 supplementation raises serum 25OHD levels in postmenopausal black women, decreases secondary hyperparathyroidism, and reduces bone turnover. These findings should spur further investigation of the use of vitamin D supplementation in the prevention of osteoporosis in this population.

Topics: Aged; Aged, 80 and over; Body Mass Index; Calcifediol; Calcitriol; Calcium, Dietary; Cholecalciferol; Collagen; Collagen Type I; Cyclic AMP; Dietary Supplements; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Parathyroid Hormone; Peptides; Postmenopause

The aim of this study was to elucidate perimenopausal bone loss in relation to menstrual conditions and to investigate the long-term effect of menopause on bone loss in aged women. The rate of change in bone mineral density (BMD) was measured twice at an exact interval of 12 months by dual-energy X-ray absorptiometry (DXA) at the lumbar spine in 176 pre- and postmenopausal healthy women 41-65 years of age. Serum follicle-stimulating hormone, intact and N-fragment osteocalcin (OC), three types of vitamin D3, parathyroid hormone (PTH), and calcitonin were also determined. Women who exercised regularly or had anatomical changes at the lumbar spine were excluded from this study. The subjects were divided into eight groups based on their menstrual status and years since menopause. Annual bone loss at the lumbar spine of premenopausal women with regular menstruation was -0.2+/-1.9% (95% confidence interval, -0.9 approximately -0.4%) and was not statistically different from zero, while that of women with irregular menstruation or at menopausal transition was -2.1+/-3.4% (-3.4 approximately -0.8%), and -3.3+/-2.3% (-5.2 approximately -0.3%), respectively, and was significantly different from zero. Serum OC levels of women at menopausal transition were significantly higher than those of women with regular menstruation, suggesting that bone loss had commenced in these women. The rate of annual change in BMD of women who were menopausal for 1-3, 4-6, 10-12, and more than 13 years was -3.1+/-4.0% (-4.7 approximately -1.5%), -1.2+/-2.6% (-2.2 approximately -0.2%), -1.0+/-3.0% (-2.3 approximately -0.3%), and -2.3+/-2.1% (-3.7 approximately -1.0%), respectively, and was significantly less than zero. But the annual bone loss of women who were menopausal for 7-9 years was -1.5+/-2.6% (-3.0 approximately -0.1%) and was not statistically significant from zero. These results indicate that postmenopausal women lose BMD in two phases. The early bone loss is rapid and commences during irregular menstruation, then is attenuated within 6 years after the onset of menopause. The second bone loss commences after the attenuation of the first bone loss. Among bone metabolic hormones, intact PTH alone showed an age-related increase and was suggested as being a causal factor of bone loss in women who were menopausal for 13 years or more.

Topics: Absorptiometry, Photon; Adult; Age Factors; Aged; Bone Density; Calcitonin; Cholecalciferol; Female; Follicle Stimulating Hormone; Humans; Japan; Lumbar Vertebrae; Menopause; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Parathyroid Hormone; Premenopause; Prospective Studies

Topics: Aged; Apolipoprotein E4; Apolipoproteins E; Bone Density; Cholecalciferol; DNA; Estrogen Replacement Therapy; Female; Humans; Osteoporosis, Postmenopausal; Polymorphism, Genetic; Polymorphism, Restriction Fragment Length; Receptors, Estrogen

Analogs related to 1 alpha,25-dihydroxy-2 beta-(3-hydroxypropoxy)vitamin D3 (ED-71) (4), oxa-type and carba-type analogs of vitamin D3 bearing substituents at the 2 beta-position of 1 alpha,25-dihydroxyvitamin D3 (1), were synthesized from the alpha-epoxides (6 and 13). Three analogs, ED-71 (4) and two carba-type analogs (16 and 26), showed potent preventive effects on bone mineral loss in pre-osteoporosis model rats. ED-71 (4) was concluded to be an optimized analog and a promising candidate for the treatment of osteoporosis.

Topics: Absorptiometry, Photon; Animals; Bone Density; Calcitriol; Cholecalciferol; Disease Models, Animal; Drug Design; Female; Humans; Osteoporosis, Postmenopausal; Ovariectomy; Rats; Rats, Wistar; Receptors, Calcitriol; Vitamin D

Topics: Bone Density; Calcitriol; Cholecalciferol; Dose-Response Relationship, Drug; Ergocalciferols; Female; Fractures, Spontaneous; Humans; Hydroxycholecalciferols; Hypercalcemia; Osteoporosis, Postmenopausal; Spinal Fractures; Vitamin D

Postmenopausal osteoporosis is not a well-defined disease, but summarizes women with different severity of changes in bone metabolism and different clinical complaints. The only common feature in women with 'postmenopausal osteoporosis' is the deficiency of estrogen. Postmenopausal women can be subdivided into four groups, according to their risk for fractures: 1. women without evident increase of fracture risk (bone mineral content between 0 and 2 SD of age-related normal range, no known risk factors from history); 2. women with possible increase of fracture risk (bone mineral content between 0 and -2 SD of age-related normal range, with or without known risk factors from history); 3. women with clear increase of fracture risk (bone mineral content below age-related normal range, with or without known risk factors from history); 4. women with already occurred fracture (manifest osteoporosis). Therapeutic intervention in postmenopausal women should be adapted to the risk for fracture. In all four groups a secondary prevention or basic therapy should be performed, focusing on calcium intake, vitamin D supply and sufficient physical activity. Calcium intake should be 1500 mg/day in women without estrogen substitution and 1000 mg in women with estrogen substitution. In patients living mainly inside or with malnutrition, a daily substitution of 500 E. Vitamin D3 is recommended. In group 2, regular control of bone mass is recommended to start additional estrogen replacement therapy, if accelerated loss of bone mass occurs. In group 3, estrogen replacement therapy is recommended urgently and is the therapy of first choice to prevent development of fractures. In group 4 (manifest osteoporosis), therapy should aim on improvement of the patient's symptoms and on increase of bone stability to avoid further fractures. The symptomatic therapy includes pain medications and an intensive physical therapy adapted to the patient's needs. Physical therapy should be performed for long time to reduce complaints and to improve musculoskeletal function in order to prevent falls. Different agents influencing bone metabolism by inhibition of bone resorption (estrogens, calcitonin, bisphosphonates) or stimulation of bone formation (fluoride) are used in manifest osteoporosis to increase bone stability. But the present efficacy to avoid further fractures has not been shown sufficiently for all available agents, so that a final evaluation and recommendation can't be done. Therapy d

Topics: Aged; Calcium; Cholecalciferol; Diphosphonates; Estrogen Replacement Therapy; Female; Fluorides; Fractures, Spontaneous; Humans; Middle Aged; Osteoporosis, Postmenopausal

In order to evaluate the preventive effect of estrogen and vitamin D3 on postmenopausal bone loss, either estrogen (Premarin 0.625 mg/day) or vitamin D3 (Onealfa 1.0 micrograms/day) was administered to postmenopausal women. Changes in lumbar bone mineral density (BMD) were monitored by dual energy X-ray absorptiometry (DEXA). The lumbar BMD of women given estrogen showed a significant increase at 6 months after treatment. The highest response to estrogen was demonstrated within a year after treatment, and thereafter the effect was diminished but still prevented further bone loss. On the other hand, the effect of vitamin D was heterogeneous. Half of the women receiving vitamin D showed a remarkable increase at a year later, but in the remainder there was a decrease and the overall there was little change from the pretreatment value. These results indicate that estrogen can be used as a first choice for the prevention of postmenopausal bone loss, but further studies on the preventive effect of vitamin D are needed.

Topics: Absorptiometry, Photon; Adult; Aged; Bone Density; Cholecalciferol; Estrogens, Conjugated (USP); Female; Humans; Middle Aged; Osteoporosis, Postmenopausal