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
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Strontium malonate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Osteologix:

Primary Outcome Measures:
  • CTX-1

Secondary Outcome Measures:
  • Other bio markers, BMD

Estimated Enrollment: 275
Study Start Date: December 2006
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409032

Locations
Denmark
PhaseOneTrials
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
Osteologix
Investigators
Principal Investigator: Richard Eastell, Professor, M.D. University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00409032     History of Changes
Other Study ID Numbers: NBS-C03-OP
Study First Received: December 7, 2006
Last Updated: October 22, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency

Keywords provided by Osteologix:
osteoporosis
BMD
CTX
Post menopausal
strontium
bone turnover
clinical development

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

ClinicalTrials.gov processed this record on April 17, 2014