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A Dose-response Study With Strontium Malonate in Postmenopausal Women

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Strontium malonate
Sponsored by
Osteologix
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, BMD, CTX, Post menopausal, strontium, bone turnover, clinical development

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • PhaseOneTrials
  • Odense University Hospital
  • Medinova Clinic
  • Synexus Wales Clinical Research Centre
  • Synexus Scotland Clinical Research Centre
  • Synexus Limited Reading Clinical Research Centre
  • University of Sheffield
  • Synexus Crosby Clinical Research Centre
  • Synexus Wigan Clinical Research Centre

Outcomes

Primary Outcome Measures

CTX-1

Secondary Outcome Measures

Other bio markers, BMD

Full Information

First Posted
December 7, 2006
Last Updated
October 22, 2009
Sponsor
Osteologix
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1. Study Identification

Unique Protocol Identification Number
NCT00409032
Brief Title
A Dose-response Study With Strontium Malonate in Postmenopausal Women
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 Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Osteologix

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, BMD, CTX, Post menopausal, strontium, bone turnover, clinical development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
275 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Strontium malonate
Primary Outcome Measure Information:
Title
CTX-1
Secondary Outcome Measure Information:
Title
Other bio markers, BMD

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Eastell, Professor, M.D.
Organizational Affiliation
University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
PhaseOneTrials
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Medinova Clinic
City
Northwood
State/Province
Middlesex
Country
United Kingdom
Facility Name
Synexus Wales Clinical Research Centre
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Centre
City
Glasgow
ZIP/Postal Code
G81 2DR
Country
United Kingdom
Facility Name
Synexus Limited Reading Clinical Research Centre
City
Reading
ZIP/Postal Code
RG2 7AG
Country
United Kingdom
Facility Name
University of Sheffield
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Synexus Crosby Clinical Research Centre
City
Waterloo
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Synexus Wigan Clinical Research Centre
City
Wigan
ZIP/Postal Code
WN1 1XX
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.osteologix.com
Description
Related Info

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A Dose-response Study With Strontium Malonate in Postmenopausal Women

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