Open Label Extension

Phase 3 Completed 91 enrolled Shire

Non-randomizedSingle-groupOpen-labelTreatment

Summary

TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in OLES and TRES combined.

Timeline

Start: 2005-01-10
Primary completion: 2006-10-27
Completion: 2006-10-27

Publications

Zanchetta JR, Bogado CE, Cisari C, Aslanidis S, Greisen H, Fox J, Lems W. Treatment of postmenopausal women with osteoporosis with PTH(1-84) for 36 months: treatment extension study. Curr Med Res Opin. 2010 Nov;26(11):2627-33. doi: 10.1185/03007995.2010.524121. Epub 2010 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Parathyroid Hormone	Protein / enzyme biologic	100 ug	—

Open Label Extension

Summary

Timeline

Publications

Drugs

Indications