INTRODUCTION: Osteoporosis is a serious problem, since about 50% of women over the age of 50 suffer at least one osteoporotic fracture. OBJECTIVE: The aim of this study was to evaluate compliance as well as the efficiency and safety of ibandronate treatment over a 6-month period in reducing the risk of subsequent fracture in women with postmenopausal osteoporosis. METHODS: A multicenter, prospective, observational study was conducted during one year in thirteen medical centres in Serbia. In the first part of the study the participants received ibandronate tablets (150 mg) once a month for six months. In the second part, the patients were under clinical follow-up. RESULTS: The mean age of the 184 menopausal women included in the study was 66.2 +/- 9.4 years. In 40.2% of the subjects the disease had been clinically manifest during the five preceding years. The mean T-score value at the onset of our investigation was -3.1 +/- 0.84 in 160 (87%) patients who were diagnosed osteoporosis. Compression vertebral fractures alone were noted in 24% of the women, spontaneous nonvertebral fractures in 49.4% and both in 4.9%. A history of osteoporotic fractures was much more common in patients with three or four risk factors (p = 0.001). Out of 39 adverse events during therapy with once monthly bisphosphonates only 2 (3.3%) were classified as severe. During the treatment, spontaneous fractures occurred in 13 (7.1%) patients. CONCLUSION: Ibadronate treatment once a month for 6 months was shown to be very safe, tolerated well and without more serious side effects.
INTRODUCTION:Osteoporosis is a serious problem, since about 50% of women over the age of 50 suffer at least one osteoporotic fracture. OBJECTIVE: The aim of this study was to evaluate compliance as well as the efficiency and safety of ibandronate treatment over a 6-month period in reducing the risk of subsequent fracture in women with postmenopausal osteoporosis. METHODS: A multicenter, prospective, observational study was conducted during one year in thirteen medical centres in Serbia. In the first part of the study the participants received ibandronate tablets (150 mg) once a month for six months. In the second part, the patients were under clinical follow-up. RESULTS: The mean age of the 184 menopausal women included in the study was 66.2 +/- 9.4 years. In 40.2% of the subjects the disease had been clinically manifest during the five preceding years. The mean T-score value at the onset of our investigation was -3.1 +/- 0.84 in 160 (87%) patients who were diagnosed osteoporosis. Compression vertebral fractures alone were noted in 24% of the women, spontaneous nonvertebral fractures in 49.4% and both in 4.9%. A history of osteoporotic fractures was much more common in patients with three or four risk factors (p = 0.001). Out of 39 adverse events during therapy with once monthly bisphosphonates only 2 (3.3%) were classified as severe. During the treatment, spontaneous fractures occurred in 13 (7.1%) patients. CONCLUSION:Ibadronate treatment once a month for 6 months was shown to be very safe, tolerated well and without more serious side effects.