Condition category
Musculoskeletal Diseases
Date applied
28/08/2007
Date assigned
17/09/2007
Last edited
08/11/2013
Prospective/Retrospective
Prospectively 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 Dieter Felsenberg

ORCID ID

Contact details

Charité Campus Benjamin Franklin
Klinik und Poliklinik für Radiologie und Nuklearmedizin
Berlin
D-12203
Belgium

Additional identifiers

EudraCT number

2007-001509-11

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-030

Study information

Scientific title

Acronym

Study hypothesis

Current hypothesis as of 03/03/2011:
To assess the effects of strontium ranelate in comparison with bisphophonate on cortical thickness, the bone geometrical parameters and bone strength in patients with postmenopausal osteoporosis

Previous hypothesis:
To assess the effects of strontium ranelate in comparison with bisphosphonate on the bone geometry and bone strength in patients with postmenopausal osteoporosis.

Please note, as of 01/03/2011 the following updates have been made to this record:
- The anticipated end date has been updated from 30/09/2010 to 30/03/2011.
- The target number of participants has been increased from 80 to 148.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Randomised double-blind double-dummy trial

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

2 g strontium ranelate versus bisphosphonate for two years.

Intervention type

Drug

Phase

Not Specified

Drug names

Strontium ranelate, bisphosphonate

Primary outcome measures

Current primary outcome measure(s) as of 01/03/2011:
Cortical thickness measured every 6 months from baseline to M024

Previous primary outcomes measure(s):
Geometrical and bone strength parameters, measured at baseline and 2 years.

Secondary outcome measures

Current secondary outcome measure(s) as of 01/03/2011:
1. Geometrical and bone strength parameters
2. Bone Mineral Density (BMD)
3. Bone markers

Main secondary outcome measure timepoints are at baseline, M012, M024


Previous secondary outcome measures(s):
1. Bone content
2. Bone density
3. Bone Mineral Density (BMD)
4. Bone markers

Main secondary outcome measure timepoints are at baseline and 2 years.

Overall trial start date

30/09/2007

Overall trial end date

30/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women of at least 50 years old
2. Post-menopausal for at least 5 years
3. Osteoporosis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Added 01/03/2011: 148 (80 at time of registration)

Participant exclusion criteria

1. Evolutive cancer during the past 5 years with a risk of bone metastases
2. Body Mass Index less than 18 or greater than 30 kg/m^2
3. Severe malabsorption

Recruitment start date

30/09/2007

Recruitment end date

30/03/2011

Locations

Countries of recruitment

Germany, Greece, Italy, Sweden

Trial participating centre

Charité Campus Benjamin Franklin
Berlin
D-12203
Belgium

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

Publication citations

Additional files

Editorial Notes