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A Dose-response Study With Strontium Malonate in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00409032
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : October 23, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Strontium malonate Phase 2

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 : Interventional  (Clinical Trial)
Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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 Start Date : December 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. CTX-1

Secondary Outcome Measures :
  1. Other bio markers, BMD

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00409032

Hvidovre, Denmark, 2650
Odense University Hospital
Odense, Denmark, 5000
United Kingdom
Medinova Clinic
Northwood, Middlesex, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, United Kingdom, CF14 5GJ
Synexus Scotland Clinical Research Centre
Glasgow, United Kingdom, G81 2DR
Synexus Limited Reading Clinical Research Centre
Reading, United Kingdom, RG2 7AG
University of Sheffield
Sheffield, United Kingdom, S5 7AU
Synexus Crosby Clinical Research Centre
Waterloo, United Kingdom, L22 0LG
Synexus Wigan Clinical Research Centre
Wigan, United Kingdom, WN1 1XX
Sponsors and Collaborators
Principal Investigator: Richard Eastell, Professor, M.D. University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom

Additional Information: Identifier: NCT00409032     History of Changes
Other Study ID Numbers: NBS-C03-OP
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: October 23, 2009
Last Verified: October 2009

Keywords provided by Osteologix:
Post menopausal
bone turnover
clinical development

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases