Effect of twelve-month physical exercise program on patients with osteoporotic vertebral fractures: a randomized, controlled trial.

UNLABELLED: We performed a randomized clinical trial to evaluate the effect of a 12-month physical exercise program on quality of life, balance, and functional mobility in postmenopausal women with osteoporotic vertebral fractures. All three outcomes improved in the intervention group and were better than in the controls. INTRODUCTION: Th aim of this study was to evaluate the effectiveness of a structured physical exercise intervention on quality of life, functional mobility, and balance in patients with osteoporotic vertebral fractures and back pain. METHODS: Seventy-eight postmenopausal women with vertebral fractures were randomized into an exercise group (n = 40) and a control group (n = 38). The mean age was 69.2 ± 7.7 years. All women had at least one osteoporotic vertebral fracture and suffered from chronic back pain. Patients with a history of vertebral and non-vertebral fracture within the past 6 months were excluded. The 40-min exercise program was conducted twice weekly for 1 year. Participants in the control group were instructed to continue their usual daily activities. Participants were assessed at baseline and at 12 months using the Quality of Life Questionnaire (QUALEFFO-41). Balance was measured with the Balance Master® System NeuroCom® and functional mobility was measured with the "timed up and go" test and "sit-to-stand" test. RESULTS: Total QUALEFFO-41 score after 12 months was significantly better in the exercise group (44.2 ± 7.5) compared to the control group (56.6 ± 9.4), p < 0.0001. Quality of life improved in domains: "Pain", "Physical function: Jobs around the house", "Physical function: Mobility", "Social function", "General health perception" in the exercise group as compared to the control group. After 12 months, balance as assessed by "Tandem Walk and Sway" became significantly better in the exercise group as compared to the control group (p = 0.02). A significant improvement in the "timed up and go" test (p = 0.02) and the "sit-to-stand" test (p = 0.01) was shown in the exercise group compared to the control group. CONCLUSIONS: This is the first 12 month-randomized clinical trial of exercise in osteoporotic women with a vertebral fracture that demonstrates improvement of three key outcome measures: quality of life, functional mobility, and balance.

[Vitrum osteomag in prevention of osteoporosis in postmenopausal women: results of the comparative open multicenter trial]. / Vitrum osteomag v profilaktike osteoporoza u zhenshchin v postmenopauze: rezul'taty sravnitel'nogo otkrytogo mnogotsentrovogo issledovaniia.

AIM: 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. MATERIAL AND METHODS: 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). RESULTS: 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%). CONCLUSION: The results of the study allow to recommend vitrum osteomag for prophylaxis of a rapid loss of bone tissue mineral density.