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Teriparatide Use in Hip Replaced Subjects

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Contents

clinicaltrials.gov/study/NCT00191321
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT001913210
Health Conditions in Trial
Osteoporosis
Osteoporosis
0
Trial Recruitment Size
600
Trial Sponsor
Eli Lilly
Eli Lilly
0
Clinical Trial Start Date
2004
0
Study Completion Date
2005
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 30
Official Name
TUHRS Study - Teriparatide Use in Hip Replaced Subjects A Pilot Study on the Use of Teriparatide in Severe Osteoporotic Women With Hip Fracture and Submitted to Hip Replacement0
Last Updated
January 26, 2007
0
Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.

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