drugset / Trial / NCT00191321

Teriparatide Use in Hip Replaced Subjects

NCT00191321

Phase 3 Completed 60 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and submitted to hip replacement The primary objective of this study is to obtain preliminary data, in a pilot group of postmenopausal women with established osteoporosis and a recent hip fracture, who underwent hip replacement 3-6 months before screening phase, about the effect of teriparatide on: * bone turnover markers: CTx, PINP and BSAP when given at the dose of 20 mcg/day by subcutaneous route for 18 months. The secondary objectives of the study are as follows: * Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as assessed by BMD measurement with dual energy x-ray absorptiometry (DXA) * Effects of teriparatide on quality of life and back pain during treatment.

Timeline

Start
2004-07
Primary completion
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriparatide Protein / enzyme biologic 20 ug Subcutaneous

Indications