Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 6:45 AM
Study NCT ID:
NCT00409032
Status:
COMPLETED
Last Update Posted:
2009-10-23
First Post:
2006-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-response Study With Strontium Malonate in Postmenopausal Women
Sponsor:
Osteologix
Organization:
Study Overview
Official Title:
A Dose-response Study With Strontium Malonate in Postmenopausal Women. A 12 Week, Multi National, Double Blind, Randomized, 5 Arms, Parallel Group Placebo Controlled Open Label Active Controlled, Phase II Study With 3 Dose Levels of Strontium Malonate and Protelos Within Post Menopausal Women With a BMDT-score Below -1
Status:
COMPLETED
Status Verified Date:
2009-10
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 compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.
Detailed Description:
275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g Protelos® or placebo.
Patients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.
Apart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.
Patients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.
Apart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: