Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/05/2010
Date assigned
28/05/2010
Last edited
05/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rene Rizzoli

ORCID ID

Contact details

Hôpital Cantonal
Département de réhabilitation et gériatrie
Genève 14
1211
Switzerland

Additional identifiers

EudraCT number

2009-013935-39

ClinicalTrials.gov number

Protocol/serial number

CL3-06911-002

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval was obtained before recruitment of the first participants

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Strontium ranelate, Vitamin D3

Primary outcome measures

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 trial start date

27/01/2010

Overall trial end date

22/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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

Recruitment start date

27/01/2010

Recruitment end date

22/07/2011

Locations

Countries of recruitment

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

Trial participating centre

Hôpital Cantonal
Genève 14
1211
Switzerland

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes