Condition category
Musculoskeletal Diseases
Date applied
31/05/2011
Date assigned
04/08/2011
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 Maria Luisa Brandi

ORCID ID

Contact details

AOUC-D.A.I Ortopedia S.O.D
Malattie del Metabolismo Minerale ed Osseo CTO
Azienda Ospedaliero
Universitaria CareggiLargo Pelagi 1
Firenze
50139
Italy

Additional identifiers

EudraCT number

2010-020215-36

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-037

Study information

Scientific title

A prospective, controlled, double blind, international study to assess the effects of strontium ranelate vs placebo on the reduction of periprosthetic bone loss in patients with total hip arthroplasty

Acronym

Study hypothesis

To demonstrate the efficacy of strontium ranelate in the reduction of bone loss in patients with total hip arthroplasty

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Prospective placebo-controlled randomised double-blind 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

Periprosthetic bone loss / total hip arthroplasty

Intervention

Intervention (63 paticipants) - One sachet of 2g of strontium ranelate daily
Placebo (63 paticipants)
Total duration of intervention is 12 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Strontium ranelate

Primary outcome measures

The relative change of periprosthetic bone mineral density (BMD) in region 7 of Gruen after total hip arthroplasty over 12 months

Secondary outcome measures

1. The relative change of other regions of Gruen over 12 months
2. Safety over 12 months

Overall trial start date

01/05/2011

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Caucasian male or postmenopausal women
2. Age less than or equal to 50 years
3. Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication for total hip arthroplasty

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

126

Participant exclusion criteria

1. Short femoral stem
2. Any perioperative complication
3. Patient with inflammatory arthropathy
4. Impossibility to perform Dual-emission X-ray absorptiometry (DXA)
5. Increase risk or history of venous thromboembolism (VTE)
6. Known hypersensitivity or contraindication to the study drug or Calperos D3®
7. Concomittant treatments likely to interfere with bone metabolism

Recruitment start date

01/05/2011

Recruitment end date

30/04/2013

Locations

Countries of recruitment

Belgium, Brazil, Germany, Italy, Spain

Trial participating centre

AOUC-D.A.I Ortopedia S.O.D
Firenze
50139
Italy

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