Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-08 @ 4:44 AM
Study NCT ID:
NCT00583518
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2007-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)
Sponsor:
Nycomed
Organization:
Study Overview
Official Title:
Open Label, Multi-centre, Longitudinal, Prospective, Phase IV Clinical Trial to Compare Two Image Technologies (ImaTx and DXA) Assessing the Anabolic Effects of PTH(1-84) in Postmenopausal Women With Primary Osteoporosis
Status:
COMPLETED
Status Verified Date:
2012-05
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:
The primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH (1-84).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: