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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
275
PhaseOneTrials
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
Medinova Clinic
Northwood, Middlesex, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, United Kingdom
CTX-1
Other bio markers, BMD
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