Condition category
Musculoskeletal Diseases
Date applied
05/09/2007
Date assigned
16/05/2008
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 J Y Reginster

ORCID ID

Contact details

Unité d'Exploration du Métabolisme Osseux
CHU BRULL
45
Quai Godefroid Kurth
Liege
4020
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-012

Study information

Scientific title

Acronym

Study hypothesis

1. To assess the efficacy of an additional 5-year oral administration of strontium ranelate on bone mineral density (BMD), on the number of patients experiencing new osteoporotic fractures on body height and on bone markers in the SOTI and TROPOS patients having already received active treatment for 4 or 5 years
2. To allow patients treated with placebo in the main part of the SOTI study or for 5 years in the TROPOS study to receive active treatment for a duration known to be effective on vertebral fractures
3. To assess the safety of an additional 5-year oral administration of strontium ranelate in SOTI and TROPOS patients having already received active treatment for 4 or 5 years
4. To assess the safety of a 5-year oral administration of strontium ranelate in SOTI and TROPOS patients treated with placebo in the main part of the SOTI or TROPOS studies

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Open international multicentric study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

Postmenopausal osteoporosis

Intervention

All participants will take 2 g per day of strontium ranelate for five years.

Intervention type

Drug

Phase

Phase III

Drug names

Strontium ranelate

Primary outcome measures

The following will be assessed annually during the treatment:
1. Dual X-ray absorptiometry (DXA)
2. Vertebral fractures radiographs in patients having had vertebral radiographs in SOTI or TROPOS
3. Occurrence of peripheral fractures

Secondary outcome measures

Safety

Overall trial start date

09/09/2002

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Caucasian women
2. Postmenopausal
3. Osteoporosis
4. Having participated up to the SOTI or TROPOS M060 visit or withdrawn under study treatment from the SOTI or TROPOS study within a 6-month period preceding the theoretical M060 visit

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3,000

Participant exclusion criteria

1. Patients having attended the M060 or withdrawn SOTI-TROPOS visit at a time greater than one year prior to the inclusion visit of the CL3-12911-012 protocol
2. Significant concomitant disease (evolutive major illnesses)
3. Severe disease interfering with bone metabolism

Recruitment start date

09/09/2002

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Australia, Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom

Trial participating centre

Unité d'Exploration du Métabolisme Osseux
Liege
4020
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