An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

Phase 3 Completed 200 enrolled Amgen

Non-randomizedSingle-groupOpen-labelTreatment

Summary

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Timeline

Start: 2006-05-01
Primary completion: 2011-03-28
Completion: 2012-08-02

Publications

Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Denosumab	Monoclonal antibody	60 mg	Subcutaneous

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

Summary

Timeline

Publications

Drugs

Indications