A double-blind, multicentre, international randomised study to assess the effects of 6 months or 12 months administration of strontium ranelate versus biphosphonates on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis

ISRCTN ISRCTN50493318
DOI https://doi.org/10.1186/ISRCTN50493318
EudraCT/CTIS number 2006-005581-39
Secondary identifying numbers CL3-12911-025
Submission date
04/06/2007
Registration date
12/07/2007
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 of protocol

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

Contact information

Prof Pierre D. Delmas
Scientific

INSERM Unité 831
Service de Rhumatologie et de Pathologie Osseuse Pavillon F
Hôpital E. Herriot
Lyon
69437
France

Study information

Study designDouble-blind double-dummy randomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA double-blind, multicentre, international randomised study to assess the effects of 6 months or 12 months administration of strontium ranelate versus biphosphonates on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
Study objectivesTo assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with biphosphonates on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for one year.
Ethics approval(s)First Ethics Committee approval obtained on 01/03/2007 in Milan, Italy (ref: 148)
Health condition(s) or problem(s) studiedPostmenopausal osteoporosis in women
InterventionIntervention group: 2 g (one sachet) orally per day of strontium ranelate and one capsule of placebo for 6 or 12 months
Control group: one capsule of bisphosphonates and one sachet of placebo for 6 or 12 months
Intervention typeOther
Primary outcome measureHistomorphometry on paired transiliac biopsies performed at baseline and after treatment (cancellous mineralising surfaces).
Secondary outcome measures1. Other histomorphometric parameters
2. Bone markers
Overall study start date01/06/2007
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants285
Total final enrolment387
Key inclusion criteria1. Women of at least 50 years of age
2. Postmenopausal for at least three years
3. Osteoporosis
Key exclusion criteria1. Any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure or that potentially could lead to an impossibility to perform a transiliac bone biopsy on each side
2. Previous and concomitant treatments interfering with bone metabolism
Date of first enrolment01/06/2007
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czech Republic
  • Denmark
  • Estonia
  • France
  • Hungary
  • Italy
  • Mexico
  • Poland
  • United Kingdom

Study participating centre

INSERM Unité 831
Lyon
69437
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website http://www.servier.com/
ROR logo "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 shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication plan:
Summary results are published on https://clinicaltrials.servier.com/.
IPD sharing planThe 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?
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.
28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.
04/12/2017: results summary added.