A Dose-response Study With Strontium Malonate in Postmenopausal Women

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409032
• Other study ID #: NBS-C03-OP
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2006
• Last updated: October 22, 2009
• Start date: December 2006
• Est. completion date: September 2007

Study information

• Verified date: October 2009
• Source: Osteologix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Strontium malonate

Locations

Country	Name	City	State
Denmark	PhaseOneTrials	Hvidovre
Denmark	Odense University Hospital	Odense
United Kingdom	Synexus Wales Clinical Research Centre	Cardiff
United Kingdom	Synexus Scotland Clinical Research Centre	Glasgow
United Kingdom	Medinova Clinic	Northwood	Middlesex
United Kingdom	Synexus Limited Reading Clinical Research Centre	Reading
United Kingdom	University of Sheffield	Sheffield
United Kingdom	Synexus Crosby Clinical Research Centre	Waterloo
United Kingdom	Synexus Wigan Clinical Research Centre	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Osteologix

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTX-1
Secondary	Other bio markers, BMD

External Links

•   Link