Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Summary

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption To confirm general safety of 5 mg daily risedronate as compared to placebo

Timeline

Start

2002-12

Primary completion

2005-04

Completion

2005-04

Outcome

Met primary endpoint

paper At study end point, LS BMD had significantly increased from baseline in the risedronate group (P < 0.05) PMID 18035193 ↗

paper mean [SE] %Delta, +4.49% [0.38%] and +0.05% [0.54%], respectively; P < 0.001. PMID 18035193 ↗

Publications

• Results Valimaki MJ, Farrerons-Minguella J, Halse J, Kroger H, Maroni M, Mulder H, Munoz-Torres M, Saaf M, Snorre Ofjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49. doi: 10.1016/j.clinthera.2007.09.017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risedronate	Small molecule	5 mg	—

Indications