Efficacy and safety of strontium ranelate/vitamin D3 combination on vitamin D insufficiency in the treatment of osteoporotic patient

ISRCTN	ISRCTN59279012
DOI	https://doi.org/10.1186/ISRCTN59279012
EudraCT/CTIS number	2009-013935-39
Secondary identifying numbers	CL3-06911-002

Submission date: 03/05/2010
Registration date: 28/05/2010
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

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 Rene Rizzoli
Scientific

Hôpital Cantonal
Département de réhabilitation et gériatrie
Genève 14
1211
Switzerland

Study information

Study design	Randomised double-blind 2 parallel group trial followed by an open-labelled one treatment study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.
Study objectives	To demonstrate the efficacy of S06911 on the correction of vitamin D insufficiency. Please note that as of 19/11/2012, Denmark was removed from the countries of recruitment.
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Osteoporosis, vitamin D insufficiency
Intervention	First period: one sachet per day of strontium ranelate/vitamin D3 fixed combination versus strontium ranelate alone Second period: strontium ranelate/vitamin D3 fixed combination The total duration of treatment and the total duration of follow-up for our interventions is 6 or 12 months.
Intervention type	Supplement
Primary outcome measure	Evaluate the serum 25-OH vitamin D3 levels over 3 months of treatment
Secondary outcome measures	1. Evaluate the serum 25-OH vitamin D3 levels after 6 months 2. Bone mineral density (BMD) from baseline to 12 months 3. Evaluate the safety at M1 and each 3 months
Overall study start date	27/01/2010
Completion date	22/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	500
Key inclusion criteria	1. Osteoporotic men and osteoporotic post-menopausal women 2. Age superior or equal 50 years, either sex 3. Caucasian 4. 25-OH vitamin D3 serum concentration greater than 22.5 nmol/L
Key exclusion criteria	1. Progressive major illness, uncontrolled active disease, skeletal disease 2. History or increased risk of deep venous thrombosis or pulmonary embolism 3. History of intolerance, allergy or severe hypersensitivity with study drugs
Date of first enrolment	27/01/2010
Date of final enrolment	22/07/2011

Locations

Countries of recruitment

Austria
Belgium
Czech Republic
Finland
France
Germany
Hungary
Poland
Russian Federation
Slovakia
Spain
Switzerland
United Kingdom

Study participating centre

Hôpital Cantonal

Genève 14
1211
Switzerland

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Current version as of 28/03/2018: Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature. 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. Previous version as of 24/01/2018: Publication plan: All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
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?
Basic results				No	No
Results article	results	04/02/2014		Yes	No

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 and publication reference added.