A double-blind, multicentric, multinational randomised study to assess the effects of one year administration of 2 g per day of strontium ranelate versus marketed bisphosphonates in women with postmenopausal osteoporosis on bone microarchitecture as measured by high-resolution peripheral-quantitative computed tomography (p-QCT)

ISRCTN	ISRCTN82719233
DOI	https://doi.org/10.1186/ISRCTN82719233
Clinical Trials Information System (CTIS)	2006-002732-22
Protocol serial number	CL3-12911-019
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 03/03/2006
Registration date: 31/03/2006
Last edited: 18/04/2018

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 René Rizzoli
Scientific

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

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A double-blind, multicentric, multinational randomised study to assess the effects of one year administration of 2 g per day of strontium ranelate versus marketed bisphosphonates in women with postmenopausal osteoporosis on bone microarchitecture as measured by high-resolution peripheral-quantitative computed tomography (p-QCT)
Study objectives	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(s)	First Ethics Committee approval obtained on 21/09/2005 in France, ref: 2005-064-2
Health condition(s) or problem(s) studied	Post-menopausal osteoporosis
Intervention	Strontium ranelate (S12911) versus marketed bisphosphonates.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bisphosphonates, strontium ranelate
Primary outcome measure(s)	Assessment of trabecular bone volume to tissue volume
Key secondary outcome measure(s)	Assessment of bone density, bone structure and bone markers
Completion date	28/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	72
Key inclusion criteria	1. Women of at least 50 years old 2. Postmenopausal for at least five years 3. Osteoporosis
Key exclusion criteria	1. Body mass index (BMI) <18 or >30 kg/m^2 2. Skeletal disease 3. Severe malabsorption 4. Significant and evolutive hyperthyroidism
Date of first enrolment	31/10/2005
Date of final enrolment	28/02/2008

Locations

Countries of recruitment

Australia
France
Germany
Switzerland

Study participating centre

Hôpital Cantonal de Genève

Geneve 14
1211
Switzerland

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 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2010		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
06/12/2017: results summary added.