Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Phase 3 Completed 650 enrolled Ono Pharmaceutical Co., Ltd. Astellas Pharma Inc · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

Timeline

Start: 2002-08
Primary completion: 2006-09
Completion: —

Outcome

Met primary endpoint

paper Daily 1 mg minodronate for 24 months reduced the risk of vertebral fractures by 59% (95% CI, 36.6-73.3%). PMID 19101754 ↗

paper CONCLUSIONS: Daily oral minodronate is safe, well-tolerated, and is effective in reducing vertebral fracture risk in postmenopausal women with established osteoporosis. PMID 19101754 ↗

Publications

Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009 Aug;20(8):1429-37. doi: 10.1007/s00198-008-0816-7. Epub 2008 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Minodronic acid	Small molecule	1 mg	Oral