A Dose-response Study With Strontium Malonate in Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Strontium malonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women (at least 12 months since last menstruation). BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5). 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. 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, phosphorus). 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Strontium malonate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTX-1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other bio markers, BMD |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, BMD, CTX, Post menopausal, strontium, bone turnover, clinical development