Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Phase 3 Completed 1637 enrolled Eli Lilly and Company

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.

Timeline

Start: 1996-08
Primary completion: 1999-04
Completion: 1999-04

Publications

Prevrhal S, Krege JH, Chen P, Genant H, Black DM. Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin. 2009 Apr;25(4):921-8. doi: 10.1185/03007990902790993.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Teriparatide	Protein / enzyme biologic	20 ug	Subcutaneous
Subject	Teriparatide	Protein / enzyme biologic	40 ug	Subcutaneous
Background	Calcium lactate	Small molecule	1000 mg	Oral
Background	Vitamin D Supplement	Unknown	400 iu	Oral
Background	Vitamin D Supplement	Unknown	1200 iu	Oral

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Summary

Timeline

Publications

Drugs

Indications