A dose-response study with stronitum malonate in postmenopausal women. 12 week, multinational, double-blind, randomised, 5 arms, parallel group placebo controlled, open label active controlled, phaseII study with 3 dose levels of strontium malonate and Protelos within post menopausal women with a BMD T-score below -1.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 304

Inclusion Criteria

•Postmenopausal women (at least 12 months since last menstruation).
•BMD (L1-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).
•greater than or equal to 50 years of age.
•BMI<30 kg/m2.
•Total S-Ca level within normal range.
•Ability to read and understand the information given.
•The patient has signed an informed consent form according to ICH E6 and local requirements before any study specific procedure is carried out.
•Ability to comply with study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).
•History of alcohol or drug abuse.
•Metabolic bone disease (e.g. pagets disease, bone cancer).
•History of VTE/DVT.
•History of kidney transplant.
•Bilateral oophorectomy.
•Relevant and treated reduced kidney or liver function.
•Any malignancy within the last 5 years (except basal cell carcinoma)
•Any chronic condition likely to affect absorption (e.g. Crohns disease, gluten enteropathy).
•Known genetic pre-disposition to VTE/DVT
•Known hypersensitivity to any of the active substances or excipients.
•25-OH-vitamin D level below 25 nmol/L
•Any previous treatment with bisphosphonates, Strontium or fluoride.
•Treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, HRT, SERMs, PTH, phosphates).
•Treatment during the last week with tetracycline, ciprofloxacin or loop diuretics.
•PTH out of normal range
•Use of any drug known to influence the coagulation process (aspirin and other NSAID allowed)
•Prothrombin time out of normal range (sec or INR)
•Inclusion in another clinical study within 30 days before randomization or during this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare dose-response effect of three dose levels of strontium malonate to placebo on bone resportion quantified by S-CTX-1 following 12 weeks of treatment.;Secondary Objective: Secondary objectives of the study are listed on page 20 of the protocol. There is insufficient space to list all secondary objectives in this new version of EudraCT (maximum of 1000 characters only is permited in this field).;Primary end point(s): The primary endpoint is change in levels of the bone resorption marker S-CTX-1 from baseline to 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method

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