- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00409032
A Dose-response Study With Strontium Malonate in Postmenopausal Women
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
Study Overview
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 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
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Hvidovre, Denmark, 2650
- PhaseOneTrials
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Odense, Denmark, 5000
- Odense University Hospital
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Cardiff, United Kingdom, CF14 5GJ
- Synexus Wales Clinical Research Centre
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Glasgow, United Kingdom, G81 2DR
- Synexus Scotland Clinical Research Centre
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Reading, United Kingdom, RG2 7AG
- Synexus Limited Reading Clinical Research Centre
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Sheffield, United Kingdom, S5 7AU
- University of Sheffield
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Waterloo, United Kingdom, L22 0LG
- Synexus Crosby Clinical Research Centre
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Wigan, United Kingdom, WN1 1XX
- Synexus Wigan Clinical Research Centre
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Middlesex
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Northwood, Middlesex, United Kingdom
- Medinova Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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CTX-1
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Secondary Outcome Measures
Outcome Measure |
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Other bio markers, BMD
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Eastell, Professor, M.D., University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBS-C03-OP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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