Condition category
Musculoskeletal Diseases
Date applied
04/06/2007
Date assigned
12/07/2007
Last edited
28/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pierre D. Delmas

ORCID ID

Contact details

INSERM Unité 831
Service de Rhumatologie et de Pathologie Osseuse Pavillon F
Hôpital E. Herriot
Lyon
69437
France

Additional identifiers

EudraCT number

2006-005581-39

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-025

Study information

Scientific title

A double-blind, multicentre, international randomised study to assess the effects of 6 months or 12 months administration of strontium ranelate versus biphosphonates on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis

Acronym

Study hypothesis

To assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with biphosphonates on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for one year.

Ethics approval

First Ethics Committee approval obtained on 01/03/2007 in Milan, Italy (ref: 148)

Study design

Double-blind double-dummy randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Postmenopausal osteoporosis in women

Intervention

Intervention group: 2 g (one sachet) orally per day of strontium ranelate and one capsule of placebo for 6 or 12 months
Control group: one capsule of bisphosphonates and one sachet of placebo for 6 or 12 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measure

Histomorphometry on paired transiliac biopsies performed at baseline and after treatment (cancellous mineralising surfaces).

Secondary outcome measures

1. Other histomorphometric parameters
2. Bone markers

Overall trial start date

01/06/2007

Overall trial end date

31/12/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women of at least 50 years of age
2. Postmenopausal for at least three years
3. Osteoporosis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

285

Participant exclusion criteria

1. Any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure or that potentially could lead to an impossibility to perform a transiliac bone biopsy on each side
2. Previous and concomitant treatments interfering with bone metabolism

Recruitment start date

01/06/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Estonia, Hungary, Italy, Mexico, Poland, United Kingdom

Trial participating centre

INSERM Unité 831
Lyon
69437
France

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication plan:
Summary results are published on https://clinicaltrials.servier.com/.

IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 1st January 2014.


Intention to publish date

Participant level data

Available on request

Basic results (scientific)

http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-025_synopsis_report.pdf

Publication list

Publication citations

Additional files

Editorial Notes

28/03/2018: Publication plan and IPD sharing statement amended. 24/01/2018: Publication plan and IPD sharing statement added. 04/12/2017: results summary added.