cholecalciferol and tibolone

To assess the effects of tibolone on serum calcium and vitamin D3 levels, the effects on health-related quality of life (HRQOL), and the relationship between these variables.. An open-label, prospective, parallel-arm study was conducted at S.C. Das Memorial Medical and Research Center, Kolkata, India, between July 2012, and June 2013. Women aged 34-55 years were eligible when they were experiencing surgical menopause and were symptomatic. Group A comprised patients who chose to receive tibolone (2.5mg daily for 6 months) and group B comprised those who refused treatment. At baseline and 6 months, body mass index (BMI), serum calcium and vitamin D3 levels and HRQOL were assessed.. Of 79 participants, 53 were in group A and 26 in group B. After 6 months, BMI had increased significantly in both groups. The vitamin D3 level had increased significantly from baseline in group A (P=0.02), and was higher than that in group B (P=0.01). HRQOL had also improved significantly from baseline in group A (P=0.001), and was significantly better than that in group B (P<0.001). In group A, a significant correlation was found between HRQOL improvement and vitamin D3 levels (P<0.001).. Tibolone significantly increases the serum vitamin D3 level and improves HRQOL in menopausal women. Clinical Trial Registry India: CTRI/2012/06/002752.

Topics: Adult; Calcium; Cholecalciferol; Estrogen Receptor Modulators; Female; Follow-Up Studies; Humans; India; Menopause; Middle Aged; Norpregnenes; Prospective Studies; Quality of Life

To evaluate the changes in the volume of rectovaginal endometriotic nodules infiltrating the rectum during 12-month treatment with hormonal therapies.. This prospective, non-randomized, self-controlled clinical trial included patients with rectovaginal endometriotic nodules infiltrating at least the muscularis propria of the rectum, who received one of the following therapies: norethisterone acetate, triptorelin and tibolone, norethisterone acetate and letrozole, desogestrel, sequential oral contraceptive pill. The volume of the nodules was determined by virtual organ computer-aided analysis (VOCAL, GE Healthcare, USA) at baseline and after 6 and 12 months of treatment.. Eighty-three women (90.2 %) completed the 12-month treatment. When compared with baseline values, the volume of the nodules decreased at 6-month (p < 0.001) and 12-month treatment (p < 0.001). After 12-month treatment, the volume of the nodules decreased in all study groups. The volume of the nodules decreased during therapy in 68 women (73.9 %) and increased in 11 women (12.0 %).. 12-month administration of hormonal therapies reduces the volume of rectovaginal endometriotic nodules infiltrating the rectum in the majority of cases.

Topics: Adult; Aromatase Inhibitors; Calcium; Cholecalciferol; Contraceptives, Oral, Sequential; Contraceptives, Oral, Synthetic; Desogestrel; Endometriosis; Estrogen Receptor Modulators; Female; Humans; Image Processing, Computer-Assisted; Letrozole; Nitriles; Norethindrone; Norethindrone Acetate; Norpregnenes; Prospective Studies; Rectal Diseases; Treatment Outcome; Triazoles; Triptorelin Pamoate; Ultrasonography; Vaginal Diseases; Vitamins

This study compared the effects of a continuous-combined regimen of low-dose hormone therapy (LD-HT) versus tibolone and supplemental calcium/vitamin D3 (control) on quality of life (QoL) in symptomatic postmenopausal women.. This study was a prospective, randomised, double-blind, comparative trial with a control group.. The study was conducted in a climacteric outpatient clinic in the University Hospital of Federal University of Juiz de Fora, Brazil.. A total of 174 postmenopausal women under 60 years of age who attended the climacteric outpatient clinic between June 2009 and June 2011 were recruited. These women complained of moderate or intense vasomotor symptoms and exhibited no contraindications for the use of hormone therapy.. The patients were randomised into three groups: (1) daily treatment with 2.5mg tibolone (n=64), (2) 50mg calcium carbonate+200 IU vitamin D3 (Ca/Vit D3, n=54) or (3) 1mg oestradiol+0.5mg norethindrone acetate (E2/NETA, n=56) for 12 weeks.. The primary outcome was the evaluation of QoL using the Women's Health Questionnaire (WHQ) in all subjects at baseline and after 4, 8 and 12 weeks of treatment.. A total of 130 women in the following groups completed the study: tibolone (n=42), Ca/Vit D3 (n=44) and E2/NETA (n=44). An improved QoL based on the WHQ was observed at T0 (80.12±14.04, 77.73±15.3, 77.45±15.4) and T12 (57.0±15.5, 55.7±16.7, 58.4±12.6) for the tibolone, E2+NETA and Ca/Vit D3 groups, respectively (p values <0.05). The three groups exhibited significantly different scores at T12 for sexual behaviour and vasomotor symptoms. The tibolone group exhibited better sexual function compared with the E2/NETA and Ca/Vit D3 groups (4.2±26, 5.6±2.8, 5.4±2.8, respectively, p values <0.05). LD-HT was superior to tibolone and Ca/Vit D3 treatment for improvements in vasomotor symptoms (3.2±1.5, 4.0±1.8, 4.3±2.0, respectively, p values <0.05). Adverse effects were few and mild.. An improved QoL was observed in the three study groups. Tibolone primarily improved sexual function, and E2/NETA exhibited a superior response for vasomotor symptoms.

Topics: Affect; Calcium Carbonate; Cholecalciferol; Contraceptives, Oral, Synthetic; Dietary Supplements; Double-Blind Method; Drug Therapy, Combination; Estradiol; Estrogen Receptor Modulators; Estrogen Replacement Therapy; Estrogens; Female; Humans; Middle Aged; Norethindrone; Norethindrone Acetate; Norpregnenes; Postmenopause; Quality of Life; Sexual Behavior; Statistics, Nonparametric; Surveys and Questionnaires; Vitamins

Tibolone is a synthetic steroid with tissue-specific estrogenic, progestogenic, and androgenic properties. The therapeutic effects of tibolone on bone mass and strength, bone metabolic markers, and indices of histomorphometry were investigated in ovariectomized (ovx) rats on a low (0.1%)-calcium diet in comparison with 17alpha-ethynylestradiol (EE) or 1alpha-hydroxyvitamin D3 [1alpha(OH)D3]. Tibolone (0.1-3 mg/kg/day), EE (0.1 mg/kg/day), or 1alpha(OH)D3 (0.5 microg/kg/day) was administered orally once a day for 16 weeks, starting 12 weeks after ovariectomy, when the bone mineral density (BMD) of lumbar vertebrae (L4-5) and femur (global, proximal, and distal regions) had already been decreased by the combination of ovariectomy and low dietary calcium. The BMD of the lumbar vertebrae and the femur were higher in the groups treated with tibolone, EE, or 1alpha(OH)D3 than in the ovx control group. The BMD of the mid-diaphysial regions of femur and tibia, which consist mainly of cortical bone, were decreased 28 weeks after ovariectomy in the ovx control group. The BMD of the mid-diaphysial femur was higher in the groups treated with 1alpha-(OH)D3, and the BMD of mid-diaphysial tibia was higher in the groups treated with tibolone or 1alpha(OH)D3 than in the ovx control group. Like BMD, the compressive strength of the vertebral body of L2, corrected for the volume of each individual vertebra tested, was higher in the groups treated with tibolone, EE, or 1alpha(OH)D3 than in the ovx control group. Trabecular bone volume and trabecular number were reduced 12 and 28 weeks after ovariectomy but there was no change in trabecular thickness. These reduced indices were increased in the groups treated with tibolone, EE, or 1alpha(OH)D3 when compared with the ovx control group. Tibolone or EE decreased serum levels of osteocalcin and bone alkaline phosphatase and urinary levels of deoxypyridinoline and pyridinoline compared with the ovx control group. Furthermore, tibolone or EE decreased the mineralizing surface and bone formation rate as well as the osteoclast surface and osteoclast numbers. 1Alpha(OH)D3, however, did not affect these serum and urinary parameters. These data suggest that tibolone suppresses the accelerated bone turnover induced by a combination of ovariectomy and low dietary calcium, and indicate that tibolone may be a potentially useful drug for the treatment of postmenopausal osteoporosis.

Topics: Absorptiometry, Photon; Alkaline Phosphatase; Amino Acids; Anabolic Agents; Animals; Bone and Bones; Bone Density; Bone Diseases, Metabolic; Calcium; Calcium, Dietary; Cholecalciferol; Ethinyl Estradiol; Female; Norpregnenes; Osteocalcin; Ovariectomy; Rats; Rats, Sprague-Dawley; Weight-Bearing