calcitonin and Spinal-Fractures

Salmon calcitonin, available as a therapeutic agent for more than 30 years, demonstrates clinical utility in the treatment of such metabolic bone diseases as osteoporosis and Paget's disease, and potentially in the treatment of osteoarthritis. This review considers the physiology and pharmacology of salmon calcitonin, the evidence based research demonstrating efficacy and safety of this medication in postmenopausal osteoporosis with potentially an effect on bone quality to explain its abilities to reduce the risk of spine fracture, the development of an oral salmon calcitonin preparation, and the therapeutic rationale for this preparation's chondroprotective effect in osteoarthritis.

Topics: Adult; Aged; Bone Density; Bone Density Conservation Agents; Bone Resorption; Calcitonin; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Middle Aged; Osteitis Deformans; Osteoporosis, Postmenopausal; Parathyroid Hormone; Spinal Fractures; Treatment Outcome

Topics: Animals; Bone and Bones; Bone Density; Calcitonin; Disease Models, Animal; Female; Fractures, Spontaneous; Humans; Male; Osteoblasts; Osteoporosis; Spinal Fractures

Synthetic calcitonin-salmon is a treatment option for older patients with postmenopausal osteoporotic syndromes. Some clinical trials reveal a simple suppression of annual bone-loss rates with calcitonin therapy, whereas others show significant dose-related increases in vertebral and long-bone mass. Response is greater in patients with high-turnover (type I) osteoporosis than in those with the low/normal (type II) form. Candidates for calcitonin-salmon therapy include older women with established vertebral fractures, those who are osteopenic by bone mass analysis, and those in need of preventive therapy because of an accumulation of risk factors.

Topics: Aged; Calcitonin; Estrogen Replacement Therapy; Female; Humans; Osteoporosis, Postmenopausal; Spinal Fractures; Syndrome

We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.. A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily. All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily. Vertebral fractures were assessed with lateral radiographs of the spine. The primary efficacy endpoint was the risk of new vertebral fractures in the salmon calcitonin nasal spray 200-IU group compared with the placebo group.. During 5 years, 1,108 participants had at least one follow-up radiograph. A total of 783 women completed 3 years of treatment, and 511 completed 5 years. The 200-IU dose of salmon calcitonin nasal spray significantly reduced the risk of new vertebral fractures by 33% compared with placebo [200 IU: 51 of 287, placebo: 70 of 270, relative risk (RR) = 0.67, 95% confidence interval (CI): 0.47- to 0.97, P = 0.03]. In the 817 women with one to five prevalent vertebral fractures at enrollment, the risk was reduced by 36% (RR = 0.64, 95% CI: 0.43- to 0.96, P = 0.03). The reductions in vertebral fractures in the 100-IU (RR = 0.85, 95% CI: 0.60- to 1.21) and the 400-IU (RR = 0.84, 95% CI: 0.59- to 1.18) groups were not significantly different from placebo. Lumbar spine bone mineral density increased significantly from baseline (1% to 1. 5%, P<0.01) in all active treatment groups. Bone turnover was inhibited, as shown by suppression of serum type-I collagen cross-linked telopeptide (C-telopeptide) by 12% in the 200-IU group (P <0.01) and by 14% in the 400-IU group (P<0.01) as compared with placebo.. Salmon calcitonin nasal spray at a dose of 200 IU daily significantly reduces the risk of new vertebral fractures in postmenopausal women with osteoporosis.

Topics: Aged; Analysis of Variance; Bone Density; Calcitonin; Chi-Square Distribution; Double-Blind Method; Female; Fractures, Spontaneous; Humans; Middle Aged; Nasal Cavity; Osteoporosis, Postmenopausal; Reference Values; Secondary Prevention; Spinal Fractures; Treatment Outcome

The aim of this study was to examine the effect of intranasal administration of salmon calcitonin to a group of 24 postmenopausal women with severe, established osteoporosis (t score < -2.5 SD) and more than one vertebral fracture. The patients were treated with 200 IU of nasal salmon calcitonin daily for 2 months with a subsequent pause of 2 months (3 cycles) and 500 mg calcium daily over a total of 12 months in an open randomized study. The patients were compared with an age matched control group of 18 women of a similar clinical status who were treated with calcium and vitamin D only. In the nasal calcitonin treatment group an increase in the trabecular axial bone density of 2.8% was achieved, as well as increase in trabecular appendicular (forearm) bone density of 1.6%, together with a cortical bone density increase of 1.8% axial and 1% appendicular. Initially, elevated values of urinary deoxypyridinoline were found in 12 women in the nasal calcitonin treatment group; these levels returned to normal under salmon calcitonin nasal therapy and documented the inhibition of increased osteoclastic activity. Cyclic intermittent calcitonin nasal therapy led to a general increase in trabecular and cortical axial and appendicular bone density, marked alleviation of the subjective sensation of pain, and a reduction in the daily dose of accompanying nonsteroidal anti-inflammatory drugs by 50%.

Topics: Administration, Intranasal; Amino Acids; Analgesics; Animals; Anti-Inflammatory Agents, Non-Steroidal; Arm; Biomarkers; Bone Density; Bone Resorption; Calcitonin; Calcium; Female; Humans; Immunoenzyme Techniques; Middle Aged; Osteoporosis; Pain Measurement; Pilot Projects; Salmon; Spinal Fractures; Spine; Tomography, X-Ray Computed; Vitamin D

To evaluate the analgesic efficacy of calcitonin suppositories (200 IU) in comparison with bed rest and paracetamol tablets, as a rescue analgesic.. A prospective, double-blind, randomized, placebo-controlled, clinical trial.. Forty patients (8 men and 32 postmenopausal women), who had recently (within the last 5 days) suffered a nontraumatic osteoporotic vertebral fracture.. All patients were admitted to the hospital, divided randomly into two groups and received either one calcitonin or placebo suppository once a day, respectively, for 28 days. All patients were allowed to take paracetamol tablets (500 mg), with a maximum dose of six tablets daily.. Spinal pain evaluation was performed at the beginning of the study (before the initiation of treatment) and then daily until the end of the study (day 28) using the Huskinsson's visual analog scale (VAS) and a painmeter device, by direct pressure on the fractured vertebra. Pain was evaluated with the patients attempting or performing four different locomotor functions, e.g., bed rest, sitting, standing, and walking functions. Biochemical urine and plasma measurements were carried out before the initiation of treatment and on days 14 and 28.. All calcitonin-treated patients experienced an overall statistically significant (all p values < 0.001) decrease of spinal pain as assessed by the VAS and the painmeter device. Pain relief allowed for early mobilization and the gradual restoration of the locomotive functions in the calcitonin-treated group. Placebo-treated patients remained in bed for almost the whole of the observation period. At the end of the study (28th day), fasting osteocalcin, hydroxyproline/creatinine, and calcium/creatinine ratio values were statistically significantly (all p values < 0.001), lower in the calcitonin-treated than in the placebo-treated patients. In the placebo group these values showed a gradual increase. In the calcitonin-treated group side effects mainly included dizziness and enteric irritation caused by the suppositories. Enteric irritation was also present in the placebo-treated group.. Salmon calcitonin suppositories (200 IU daily) caused a dramatic decrease in spinal pain in patients with recent osteoporotic vertebral fractures and influenced the early mobilization and the gradual restoration of their locomotor functions.

Topics: Acute Disease; Aged; Aged, 80 and over; Analgesics; Calcitonin; Female; Humans; Male; Middle Aged; Osteoporosis; Pain; Pain Measurement; Placebos; Prospective Studies; Spinal Fractures; Suppositories; Walking

The aim of this study was to assess the efficacy and safety of nasal spray and subcutaneous formulations of salmon calcitonin. Two-hundred-four patients, 27 males and 177 females, aged 72 years on average, with a recent, painful, vertebral crush fracture were given either 50 IU/day of subcutaneous salmon calcitonin (SCSCT, 102 patients) or 200 IU/day of intranasal salmon calcitonin (INSCT, 102 patients) for 30 consecutive days, according to a double-blind, double-placebo design. The two-sided 95% confidence interval of the difference between the two formulations for the pain on D30 assessed by Huskisson's Visual Analogue Scale (VAS) [-5.3 mm, 7.9 mm] was included in the [-10 mm, 10 mm] reference interval. Equivalence of the two formulations, was demonstrated. At the end of the study, the 95% confidence intervals of VAS of both treatment groups were included in the [0 mm, 30 mm] interval, which is considered to be clinically pertinent. Relief was obtained in less than 10 days for more than 50% of patients. The urinary hydroxyproline/creatinine and calcium/creatinine ratios remained constant between D1 and D30 with both formulations. General safety was comparable between the two formulations. Local safety of INSCT was similar to that of its placebo.

Topics: Administration, Intranasal; Adult; Aerosols; Aged; Aged, 80 and over; Analgesics; Calcitonin; Calcium; Creatinine; Double-Blind Method; Female; France; Humans; Hydroxyproline; Injections, Subcutaneous; Longitudinal Studies; Male; Middle Aged; Pain; Spinal Fractures; Therapeutic Equivalency; Treatment Outcome

Seventy-two postmenopausal osteoporotic women having more than one nontraumatic vertebral crush fracture were studied. Thirty-six of them, aged 68.8 +/- 1.2 years (18 +/- 4 YSM-years since menopause), were treated with 100 IU/day of salmon calcitonin i.m. plus 500 mg of elemental calcium for 10 days each month. The remaining 36 patients, aged 69.6 +/- 1.4 years (19 +/- 3 YSM), were given only 500 mg of elemental calcium for 10 days each month. All patients underwent clinical and analytical evaluation every 3 months. Radiological evaluation, assessment of vertebral deformities, and metacarpal radiogrammetry were done every 6 months. Densitometric measurements of total and regional bone mass were made every 12 months. At 24 months, the calcitonin group showed a 60% reduction in the number of new fractures and the group receiving only calcium had a 45% increase (P < 0.001). The incidence of vertebral fractures was 0.07 per patient-year in the group treated with calcitonin and 0.45 per patient-year in the group treated with calcium (P < 0.001). At 2 years, the calcitonin group showed a 12% increase in cortical bone mass on metacarpal radiogrammetry, a 16% increase in the axial skeleton on trunk densitometry, a 3.5% increase in total body bone mineral content, a 30.7% increase in pelvic bone mineral content, and a 6.2% increase in arm bone mineral content (all P < 0.001). In the group treated with calcium alone there was a loss of bone mass in every region. These findings suggest that salmon calcitonin is effective in the treatment of osteoporosis and show that it acts on cortical and trabecular bone.

Topics: Absorptiometry, Photon; Aged; Arm; Biomarkers; Bone Density; Calcitonin; Calcium; Chi-Square Distribution; Female; Follow-Up Studies; Humans; Injections, Intramuscular; Metacarpus; Osteoporosis, Postmenopausal; Pelvic Bones; Prospective Studies; Risk Factors; Spinal Fractures; Spine

To study the dose related response of salmon calcitonin (salcatonin) given intranasally on bone mass and bone turnover and the effect of salcatonin on rates of fracture in elderly women with moderate osteoporosis.. Double blind, placebo controlled, randomised group comparison.. Outpatient clinic for research into osteoporosis.. 208 healthy women aged 68-72 years who had a bone mineral content of the distal forearm on average 30% below the mean value for healthy premenopausal women.. The 208 women were allocated randomly in blocks of four to two years of treatment with either salcatonin 50 IU, 100 IU, or 200 IU given intranasally or placebo. All groups received a calcium supplement of 500 mg. 32 of the women left the study before its end and 164 women complied with the study criteria throughout.. Bone mineral content of the distal forearm and lumbar spine and rates of vertebral and peripheral fractures after two years of treatment.. The average changes in bone mineral content of the spine showed positive outcomes of 1% (95% confidence interval -0.1% to 1.5%) in the group treated with calcium (placebo) and 3% (1.8% to 4.2%) in the group treated with salcatonin 200 IU. There was a significant dose related response to salcatonin, manifested by an increase of 1.0%/100 IU (0.2% to 1.7%, p = 0.008). The rate of patients with new fractures was reduced significantly in the women treated with salcatonin to about one third of that in the non-salcatonin treated women (relative risk 0.23 (0.07 to 0.77)).. The results suggest that, compared with calcium alone, salcatonin given intranasally reduces the rates of fracture by two thirds in elderly women with moderate osteoporosis. Furthermore, it increases spinal bone mass in a dose dependent manner.

Topics: Administration, Intranasal; Aged; Bone and Bones; Bone Density; Calcitonin; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fractures, Bone; Humans; Osteoporosis, Postmenopausal; Prospective Studies; Spinal Fractures; Treatment Outcome

The effectiveness of calcitonin on the vertebral fracture rate in postmenopausal osteoporosis was assessed through the skeletal deformity index (SDI) and the new vertebral fracture rate per 100 patient-years in a group of 32 women with postmenopausal osteoporosis treated by us with 100 IU of salmon calcitonin and 500 mg of elemental calcium for 10 consecutive days each month, and in another group of 28 women with postmenopausal osteoporosis treated with 500 mg of elemental calcium only for 10 consecutive days each month. Both groups were age-matched. The follow-up was a retrospective randomized study over 24 months. Thirty of the 32 women of the calcitonin group and 27 of 28 women of the calcium group finished treatment. The SDI was stabilized after six months in the calcitonin group (0.57 +/- 0.13, 0.62 +/- 0.18, 0.63 +/- 0.16 and 0.64 +/- 0.17, at base line, 6, 12 and 24 months respectively). The calcium group showed a significant increase only at 12 months (P less than 0.01) and 24 months (P less than 0.05) (0.61 +/- 0.16, 0.63 +/- 0.16, 0.69 +/- 0.16, and 0.73 +/- 0.15, at base line, 6, 12 and 24 months respectively). At 24 months, the new vertebral fracture rate decreased by 60% (20%, 14% and 8% at 6, 12 and 24 months respectively) in the calcitonin group and increased by 35% (31%, 33% and 42%, at 6, 12 and 24 months respectively) in the calcium group (P less than 0.025). These results show that calcitonin induced a significant reduction in postmenopausal osteoporotic vertebral fractures.

Topics: Aged; Calcitonin; Female; Follow-Up Studies; Humans; Osteoporosis, Postmenopausal; Retrospective Studies; Spinal Fractures; Syndrome

Back pain due to vertebral collapse is the main symptom of postmenopausal osteoporosis. The clinical picture in these crush fractures varies, depending on the type and the location of fracture, but in general, a new vertebral crush fracture gives rise to severe pain that immobilizes the patient and necessitates bedrest. In this double-blind controlled clinical trial, 56 patients who had recently (within the last 3 days) suffered an osteoporotic vertebral fracture were hospitalized for a period of 14 days. Salmon calcitonin (100 IU) or placebo injections were given daily. Pain was rated daily on a 10-point scale by the same observers. Blood and urinary parameters were also evaluated. The results showed a significant (P less than 0.001) difference in pain intensity between the calcitonin group and the placebo group. This beneficial effect was generally apparent from the second day of treatment onward, and over the following 2 weeks, the patients were able to sit and stand, and gradually started to walk again. A significant decrease in urinary hydroxyproline and urinary calcium was also noted in the calcitonin group. It is concluded that calcitonin exerts a beneficial effect on back pain following a vertebral crush fracture.

Topics: Aged; Analgesics; Calcitonin; Calcium; Double-Blind Method; Female; Humans; Hydroxyproline; Osteoporosis, Postmenopausal; Pain; Spinal Fractures

Topics: Alendronate; Bone and Bones; Bone Density; Bone Density Conservation Agents; Calcitonin; Dietary Supplements; Female; Fractures, Bone; Hip Fractures; Humans; Male; Osteoporosis; Osteoporosis, Postmenopausal; Spinal Fractures; Teriparatide; Vitamin D; Vitamin D Deficiency

Menopausal osteoporotic women (age: 49-69, mean: 59.5 years) with crush fractures of the spine were treated with low doses of calcitonin (Miacalcic, 350 U/month), or with calcitonin + anabolic steroid (Retabolil, 50 mg/month). Efficacy of the therapy was controlled by single foton absorptiometry of midshaft and distal radius, by X-ray morphometry and by registering new crush fractures of the spine. Calcitonin monotherapy stopped further bone loss for two years, but at the end of the third year both absorptiometric values, as well as the radiomorphometrical index of the lumbar spine decreased significantly. In patients on calcitonin+anabolic steroid the decrease was just significant and only at radius midshaft, while at the other measured sites it was not. Two new crush fractures per 1396 patient-months occurred. Intermittent administration of low-dose calcitonin, especially together with an anabolic steroid seems to be a safe and effective therapy in established osteoporosis.

Topics: Aged; Calcitonin; Drug Therapy, Combination; Female; Fractures, Spontaneous; Humans; Middle Aged; Nandrolone; Nandrolone Decanoate; Osteoporosis, Postmenopausal; Spinal Fractures

Calcitonin has been observed to have an analgesic effect on painful bone conditions. A case illustrating the antinociceptive effect of calcitonin on bone pain caused by osteoporotic vertebral compression fracture is presented. There is increasing clinical evidence supporting this phenomenon, though few rigorously controlled studies exist. Calcitonin may have an advantage over other analgesics in the treatment of bone pain resulting from an osteoporotic compression fracture, because, in addition to the observed analgesic effect, it is useful in treating the underlying disorder.

Topics: Aged; Analgesics; Calcitonin; Female; Humans; Osteoporosis, Postmenopausal; Pain; Spinal Fractures; Thoracic Vertebrae