Status:
COMPLETED
A Dose-response Study With Strontium Malonate in Postmenopausal Women
Lead Sponsor:
Osteologix
Conditions:
Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
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 fol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00409032
Start Date
December 1 2006
End Date
September 1 2007
Last Update
October 23 2009
Active Locations (9)
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1
PhaseOneTrials
Hvidovre, Denmark, 2650
2
Odense University Hospital
Odense, Denmark, 5000
3
Medinova Clinic
Northwood, Middlesex, United Kingdom
4
Synexus Wales Clinical Research Centre
Cardiff, United Kingdom, CF14 5GJ