A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis.

INTRODUCTION: In a randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of minodronate were examined and compared to that of alendronate.

METHODS: A total of 270 postmenopausal osteoporotic women >or=45 years of age were randomized into the minodronate group (n=135) or alendronate group (n=135). Each subject received 1 mg minodronate or 5 mg alendronate once a day for 12 months.

RESULTS: Both treatment groups showed similar changes in BMD after 12 months. After 1 year of treatment, the lumbar spine BMD increased by 5.86% and 6.29% in the minodronate and alendronate groups, respectively, and the total hip BMD increased by 3.47% and 3.27%, respectively. Bone turnover markers were rapidly reduced within 1 month in both treatment groups. Urine DPD was significantly lower in the minodronate group than in the alendronate group at 6 months, and urine NTX was significantly lower in the minodronate group than in the alendronate group at 1 and 9 months. Both completion rates for the 12-month study and the overall incidence of clinical adverse events, including gastrointestinal events, were similar between the two groups.

CONCLUSIONS: The effects on lumbar and hip BMD and the safety profile of minodronate are comparable to those of alendronate. Minodronate is a promising new potent bisphosphonate for the treatment of osteoporosis.