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A Dose-response Study With Strontium Malonate in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Osteologix
ClinicalTrials.gov Identifier:
NCT00409032
First received: December 7, 2006
Last updated: October 22, 2009
Last verified: October 2009

December 7, 2006
October 22, 2009
December 2006
August 2007   (final data collection date for primary outcome measure)
CTX-1
Same as current
Complete list of historical versions of study NCT00409032 on ClinicalTrials.gov Archive Site
Other bio markers, BMD
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoporosis
Drug: Strontium malonate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
September 2007
August 2007   (final data collection date for primary outcome measure)

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
Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   United Kingdom
 
NCT00409032
NBS-C03-OP
Not Provided
Not Provided
Osteologix
Not Provided
Principal Investigator: Richard Eastell, Professor, M.D. University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom
Osteologix
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP