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

ISRCTN	ISRCTN47943635
DOI	https://doi.org/10.1186/ISRCTN47943635
EudraCT/CTIS number	2009-014270-18
Secondary identifying numbers	CL3-06911-003

Submission date: 20/05/2010
Registration date: 15/06/2010
Last edited: 20/04/2020

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

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

Contact information

Prof Rene Rizzoli
Scientific

Département de réhabilitation et gériatrie
Hôpital Cantonal
Genève 14
1211
Switzerland

Study information

Study design	Prospective open-labelled phase III study
Primary study design	Interventional
Secondary study design	Non 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 deficiency in the treatment of osteoporotic postmenopausal women and men. A 12 month, prospective, open labelled, one treatment group international phase III study.
Study hypothesis	To demonstrate the efficacy and the safety of S06911 in patients with vitamin D deficiency. Please note that as of 27/11/2012, the following changes were made to the record: 1. Denmark was removed from the countries of recruitment 2. The anticipated end date was updated from 27/07/2011 to 30/06/2011
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Condition	Osteoporosis, vitamin D deficiency
Intervention	One sachet per day of strontium ranelate/vitamin D3 fixed combination during 12 months.
Intervention type	Supplement
Primary outcome measure	Evaluate the efficacy over 12 months of treatment on the correction of vitamin D insufficiency in patients with deficient vitamin D serum levels
Secondary outcome measures	1. Evaluate the efficacy over 12 months of treatment on the correction of vitamin D deficiency 2. Safety evaluation each 3 months
Overall study start date	27/01/2010
Overall study end date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Total final enrolment	19
Participant inclusion criteria	1. Osteoporotic men and osteoporotic post-menopausal women 2. Age superior or equal 50 years 3. Caucasian 4. 25-OH vitamin D3 serum concentration inferior or equal to 22.5 nmol/L
Participant exclusion criteria	1. Progressive major illness 2. Uncontrolled active disease 3. Skeletal disease 4. History or increased risk of deep venous thrombosis or pulmonary embolism 5. History of intolerance, allergy or severe hypersensitivity with study drugs
Recruitment start date	27/01/2010
Recruitment end date	30/06/2011

Locations

Countries of recruitment

Belgium
Poland
Russian Federation
Slovakia
Spain
Switzerland

Study participating centre

Département de réhabilitation et gériatrie

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
Basic results			20/04/2020	No	No

Editorial Notes

20/04/2020: 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.
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.
20/12/2017: results summary added.