Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-01 @ 1:36 PM
Study NCT ID:
NCT00365456
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2006-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Parathyroid Hormone (PTH 1-84) Followed by 12 Months of Treatment With Risedronate Followed by Either 12 Months Treatment With PTH (1-84) or Risedronate.
Status:
COMPLETED
Status Verified Date:
2012-08
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:
PEAK
Brief Summary:
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.
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?: