Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345644
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2006-03-20
Brief Title:
Risedronate in Osteopenic Postmenopausal Women
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography A 24 Month Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo
Status:
COMPLETED
Status Verified Date:
2009-12
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:
OSMAUSE
Brief Summary:
The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume BVTV in osteopenic postmenopausal women as measured by three-dimensional peripheral quantitative computed tomography 3D pQCT
The secondary objectives are to compare the percent change from ScreeningBaseline between the 2 treatment groups for the following measurements
Bone mineral density of the lumbar spine femoral neck femoral trochanter and total proximal femur using a dual energy X-ray absorptiometry DXA scan at 12 and 24 months
3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6 12 and 24 months and
Bone turnover markers BTMs of
fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen CTX 1
serum aminoterminal propeptide of type 1 procollagen PINP and
urine N-telopeptide cross-links NTX at 3 6 12 and 24 months
The secondary objectives are to compare the percent change from ScreeningBaseline between the 2 treatment groups for the following measurements
Bone mineral density of the lumbar spine femoral neck femoral trochanter and total proximal femur using a dual energy X-ray absorptiometry DXA scan at 12 and 24 months
3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6 12 and 24 months and
Bone turnover markers BTMs of
fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen CTX 1
serum aminoterminal propeptide of type 1 procollagen PINP and
urine N-telopeptide cross-links NTX at 3 6 12 and 24 months
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 |
|---|---|---|---|
| EudraCT 2005-005598-30 | None | None | None |