Condition category
Musculoskeletal Diseases
Date applied
28/05/2010
Date assigned
05/07/2010
Last edited
05/11/2013
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 Maria Brandi

ORCID ID

Contact details

University of Florence
Department of Internal Medicine
Division of Rheumatology and Metabolic bone Disease
Viale Pieraccini
18
Florence
50139
Italy

Additional identifiers

EudraCT number

2009-014271-41

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-035

Study information

Scientific title

A multicentre, prospective, randomised, double-blind, placebo-controlled, international study to assess the effects of 2 g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women

Acronym

The “Fracture healing” study

Study hypothesis

To demonstrate the efficacy of strontium ranelate 2 g versus placebo in accelerating radiological healing of distal radius fractures.

Please note that as of 27/11/2012, Belgium, Russian Federation and Ukraine were added to the countries of recruitment.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Radius fracture, Osteoporosis

Intervention

One daily administration of strontium ranelate 2 g or placebo during 24 weeks. There is no visit after the last intake at week-24.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Time to radiological healing. Radiological evaluation will be performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit.

Secondary outcome measures

1. Other radiological evaluations, performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit.
2. Clinical evaluation (including mobility, quality of life, etc), performed at least once every 4 weeks from baseline to week 18 and at the last study visit
3. Safety evaluation, performed at least once every 4 weeks from baseline to week 18 and at the last study visit

Overall trial start date

01/05/2010

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Osteoporotic men and osteoporotic post-menopausal women
2. Aged superior or equal to 50 years
3. Patient with a fracture of the distal radius (Colles' fracture)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Fractures not meeting inclusion criteria (including displaced radius fractures)
2. Concomitant treatments likely to interfere with bone metabolism

Recruitment start date

01/05/2010

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Belgium, Brazil, Czech Republic, France, Germany, Hungary, Italy, Russian Federation, Ukraine, United Kingdom

Trial participating centre

University of Florence
Florence
50139
Italy

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