Prospective clinical study of once monthly ibandronate in the treatment of osteoporosis and prevention of fractures in postmenopausal women: ORPHEUM Study.

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.