NCT00409032

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 23, 2009

Status Verified

October 1, 2009

Enrollment Period

8 months

First QC Date

December 7, 2006

Last Update Submit

October 22, 2009

Conditions

Osteoporosis

Keywords

osteoporosisBMDCTXPost menopausalstrontiumbone turnoverclinical development

Outcome Measures

Primary Outcomes (1)

  • CTX-1

Secondary Outcomes (1)

  • Other bio markers, BMD

Interventions

Strontium malonateDRUG

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

PhaseOneTrials

Hvidovre, 2650, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Medinova Clinic

Northwood, Middlesex, United Kingdom

Location

Synexus Wales Clinical Research Centre

Cardiff, CF14 5GJ, United Kingdom

Location

Synexus Scotland Clinical Research Centre

Glasgow, G81 2DR, United Kingdom

Location

Synexus Limited Reading Clinical Research Centre

Reading, RG2 7AG, United Kingdom

Location

University of Sheffield

Sheffield, S5 7AU, United Kingdom

Location

Synexus Crosby Clinical Research Centre

Waterloo, L22 0LG, United Kingdom

Location

Synexus Wigan Clinical Research Centre

Wigan, WN1 1XX, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Richard Eastell, Professor, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

October 23, 2009

Record last verified: 2009-10

Locations

DK(2)GB(7)