Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078026
Status:
TERMINATED
Last Update Posted:
2014-02-05
First Post:
2004-02-16
Brief Title:
An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase III Randomized Study of the Short-Term Effects of APOMINE vs Placebo in Postmenopausal Women With Osteoporosis or Low Bone Mass
Status:
TERMINATED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoporosis affects millions of postmenopausal women in the USA The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass Another possible treatment consists of drugs that increase bone formation There are currently two drugs that stimulate bone formation sodium fluoride and human parathyroid hormone hPTH Neither of these two drugs has been approved by the FDA APOMINE has shown significant bone formation in animal studies In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass
Detailed Description:
This study is a randomized placebo-controlled double-blind parallel-group study to investigate the efficacy and safety of administering 3 dose levels of APOMINE at 25 50 or 100 mgday or placebo once a day as a capsule to postmenopausal women with low bone mass or osteoporosis Eligible patients must be women between 45 and 75 years of age have a diagnosed low bone mineral density or osteoporosis and be at least 3 years post menopause The primary endpoint of the study will be changes in bone formation markers bone alkaline phosphatase and osteocalcin The secondary endpoint of the study will be changes in bone formation markers bone alkaline phosphatase osteocalcin and P-ICP and bone resorption markers serum C-telopeptide urinary N-telopeptide Blood samples will be drawn at each study visit to determine these bone markers as well as for normal laboratory tests Bone mineral density measurements DEXA will be performed at the beginning and at the end of the study Up to 60 subjects will be randomized as a cohort for treatment and treated with 25 50 or 100 mgday or placebo 15 subjects per group All enrolled subjects will receive a daily calcium and Vitamin D supplement
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