Efficacy of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal women

ISRCTN	ISRCTN51868986
DOI	https://doi.org/10.1186/ISRCTN51868986
Clinical Trials Information System (CTIS)	2009-014271-41
Protocol serial number	CL3-12911-035
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 28/05/2010
Registration date: 05/07/2010
Last edited: 21/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Maria Brandi
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	The Fracture healing study
Study objectives	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(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	200
Total final enrolment	217
Key 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)
Key exclusion criteria	1. Fractures not meeting inclusion criteria (including displaced radius fractures) 2. Concomitant treatments likely to interfere with bone metabolism
Date of first enrolment	01/05/2010
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

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

Study participating centre

University of Florence

Florence
50139
Italy

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Basic results			21/04/2020	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.
11/12/2017: results summary added.