A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus bisphosphonate in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT)

ISRCTN	ISRCTN10335153
DOI	https://doi.org/10.1186/ISRCTN10335153
Clinical Trials Information System (CTIS)	2007-001509-11
Protocol serial number	CL3-12911-030
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 28/08/2007
Registration date: 17/09/2007
Last edited: 28/03/2018

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 Dieter Felsenberg
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised double-blind double-dummy trial
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 two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT).
Study objectives	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(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Post-menopausal osteoporosis
Intervention	2 g strontium ranelate versus bisphosphonate for two years.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Strontium ranelate, bisphosphonate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key inclusion criteria	1. Women of at least 50 years old 2. Post-menopausal for at least 5 years 3. Osteoporosis
Key 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
Date of first enrolment	30/09/2007
Date of final enrolment	30/03/2011

Locations

Countries of recruitment

Belgium
Germany
Greece
Italy
Sweden

Study participating centre

Charité Campus Benjamin Franklin

Berlin
D-12203
Belgium

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?
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

24/01/2018: Publication plan and IPD sharing statement amended.
11/12/2017: results summary and publication reference added.