Condition category
Musculoskeletal Diseases
Date applied
21/06/2010
Date assigned
09/07/2010
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 Jean-Marc Feron

ORCID ID

Contact details

Hôpital Saint Antoine
Service d’orthopédie et de traumatologie
184 rue du Faubourg St Antoine
Paris Cedex 12
F 75571
France

Additional identifiers

EudraCT number

2009-017039-16

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-036

Study information

Scientific title

Effect of strontium ranelate (2 g per day) in the management of long bone fractures with delayed-union or non union: an international open label study in patients with osteoporosis

Acronym

Study hypothesis

Current study hypothesis as of 30/11/2012:
To assess the effects of strontium ranelate 2 g/day in the management of aseptic fractures of long bones with delayed union or non-union

As of 27/07/11:
To assess the effects of strontium ranelate 2 g/day in the management of aseptic fractures of limbs with delayed union or non-union

As of 09/07/10:
To assess the effects of strontium ranelate 2 g/day in the management of aseptic fractures of the lower limbs with delayed union or non-union.

Please note that as of 30/11/2012, the following changes were made to the record:
1. The anticipated end date was updated from 31/12/2011 to 30/04/2013
2. France and Germany were removed from the countries of recruitment, and Romania was added
3. The public title was previously "Efficacy of strontium ranelate in the management of limb fractures in osteoporotic patients"
4. The scientific title was previously "Effect of strontium ranelate (2 g per day) in the management of limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis"

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Open labelled treatment period of 12 months

Primary study design

Interventional

Secondary study design

Non 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

Lower long bone fracture

Intervention

One sachet of strontium ranelate (2 g per day) during 12 months.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

1. Radiological union of the fracture, performed every 2 or 3 months during the study
2. Clinical assessments (including pain, quality of life, mobility, etc.), performed every 2 or 3 months during the study (mobility test performed every 6 months)
3. Safety evaluations, performed every 2 or 3 months during the study

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/06/2010

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

30/11/2012: Current inclusion criteria as of 01/09/2011:
1. Men aged > 18 years and postmenopausal women menopause >2 years
2. Patient with long bone fracture with a delayed union or a non-union

As of 27/07/11:
1. Osteoporotic men and osteoporotic postmenopausal women.
2. Patient with a fracture of limb with a delayed union or a non-union

As of 09/07/10:
1. Osteoporotic men and osteoporotic postmenopausal women
2. Patient with a fracture of the lower limbs with a delayed union or a non-union

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Fractures not meeting inclusion criteria (including pathological fractures)
2. Bone-related disease other than osteoporosis
3. Concomittant treatments interfering with bone metabolism

Recruitment start date

15/06/2010

Recruitment end date

30/04/2013

Locations

Countries of recruitment

Brazil, Czech Republic, Hungary, Italy, Portugal, Romania

Trial participating centre

Hôpital Saint Antoine
Paris Cedex 12
F 75571
France

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