Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191321
Status:
COMPLETED
Last Update Posted:
2007-01-26
First Post:
2005-09-12
Brief Title:
Teriparatide Use in Hip Replaced Subjects
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
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 Replacement
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mcgday 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
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 mcgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B3D-IT-GHCU | None | None | None |