Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

Summary

The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

Timeline

Start

2007-04

Primary completion

2009-06

Completion

2009-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs BA058 40 µg; p <0.001; ANOVA NCT00542425 ↗

registry analysis (superiority or other test); Placebo vs BA058 80 µg; p <0.001; ANOVA NCT00542425 ↗

Publications

• Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abaloparatide	Peptide	20 ug	Subcutaneous
Subject	Abaloparatide	Peptide	40 ug	Subcutaneous
Subject	Abaloparatide	Peptide	80 ug	Subcutaneous
Comparator	Teriparatide	Protein / enzyme biologic	20 ug	Subcutaneous

Indications