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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2006

Last Updated Date

October 22, 2009

Start Date ^ICMJE

December 2006

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CTX-1

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00409032 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Other bio markers, BMD

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Dose-response Study With Strontium Malonate in Postmenopausal Women

Official Title ^ICMJE

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

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 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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: Strontium malonate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

275

Completion Date

September 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00409032

Other Study ID Numbers ^ICMJE

NBS-C03-OP

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Osteologix

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Richard Eastell, Professor, M.D.

University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom

Information Provided By

Osteologix

Verification Date

October 2009

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

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