A Dose-response Study With Strontium Malonate in Postmenopausal Women
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Other bio markers, BMD
|Study Start Date:||December 2006|
|Study Completion Date:||September 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
|Hvidovre, Denmark, 2650|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Northwood, Middlesex, United Kingdom|
|Synexus Wales Clinical Research Centre|
|Cardiff, United Kingdom, CF14 5GJ|
|Synexus Scotland Clinical Research Centre|
|Glasgow, United Kingdom, G81 2DR|
|Synexus Limited Reading Clinical Research Centre|
|Reading, United Kingdom, RG2 7AG|
|University of Sheffield|
|Sheffield, United Kingdom, S5 7AU|
|Synexus Crosby Clinical Research Centre|
|Waterloo, United Kingdom, L22 0LG|
|Synexus Wigan Clinical Research Centre|
|Wigan, United Kingdom, WN1 1XX|
|Principal Investigator:||Richard Eastell, Professor, M.D.||University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom|