Condition category
Musculoskeletal Diseases
Date applied
03/03/2006
Date assigned
31/03/2006
Last edited
13/08/2014
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 René Rizzoli

ORCID ID

Contact details

Hôpital Cantonal de Genève
Département de Réhabilitation et Gériatrie
Service des Maladies Osseuses
24
Rue Micheli–du-Crest
Geneve 14
1211
Switzerland

Additional identifiers

EudraCT number

2006-002732-22

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-019

Study information

Scientific title

Acronym

Study hypothesis

To demonstrate the effects of strontium ranelate on bone microarchitecture in women with postmenopausal osteoporosis in comparison with marketed bisphosphonates.

On 27/11/2012 the anticipated end date for this trial was updated from 31/10/2007 to 28/02/2008.

Ethics approval

First Ethics Committee approval obtained on 21/09/2005 in France, ref: 2005-064-2

Study design

Double-blind 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

Post-menopausal osteoporosis

Intervention

Strontium ranelate (S12911) versus marketed bisphosphonates.

Intervention type

Drug

Phase

Not Specified

Drug names

Bisphosphonates, strontium ranelate

Primary outcome measures

Assessment of trabecular bone volume to tissue volume

Secondary outcome measures

Assessment of bone density, bone structure and bone markers

Overall trial start date

31/10/2005

Overall trial end date

28/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women of at least 50 years old
2. Postmenopausal for at least five years
3. Osteoporosis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

72

Participant exclusion criteria

1. Body mass index (BMI) <18 or >30 kg/m^2
2. Skeletal disease
3. Severe malabsorption
4. Significant and evolutive hyperthyroidism

Recruitment start date

31/10/2005

Recruitment end date

28/02/2008

Locations

Countries of recruitment

Australia, France, Germany, Switzerland

Trial participating centre

Hôpital Cantonal de Genève
Geneve 14
1211
Switzerland

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20512336

Publication citations

  1. Results

    Rizzoli R, Laroche M, Krieg MA, Frieling I, Thomas T, Delmas P, Felsenberg D, Strontium ranelate and alendronate have differing effects on distal tibia bone microstructure in women with osteoporosis., Rheumatol. Int., 2010, 30, 10, 1341-1348, doi: 10.1007/s00296-010-1542-y.

Additional files

Editorial Notes