Condition category
Musculoskeletal Diseases
Date applied
26/01/2006
Date assigned
06/03/2006
Last edited
06/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philipp Schuetz

ORCID ID

Contact details

Petersgraben 4
Basel
4031
Switzerland
Schuetzp@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00262392

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The purpose of this study is to determine whether bisphosphonates in comparison to radiation therapy are effective in the prophylaxis and treatment of Heterotopic Ossification (HO) in high-risk patients

Ethics approval

The trial was approved by the Ethics Committee of Basel (EKBB), reference number: 129/05

Study design

Prospective, active-controlled, intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Established heterotopic ossification

Intervention

Pamidronate (Aredia) versus radiation therapy

Intervention type

Drug

Phase

Not Specified

Drug names

Pamidronate

Primary outcome measures

Primary endpoint is the radiological HO recurrence rate

Secondary outcome measures

Secondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers)

Overall trial start date

01/06/2005

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive patients with established HO (Brooker grade III-IV), hospitalized for resection of HO lesions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Age <20 years
2. Vitamin D deficiency (25OH vitamin D <30 ng/ml)
3. Renal insufficiency (clearance <50 ml/min)
4. Intolerance of bisphosphonates
5. Unable to provide informed consent

Recruitment start date

01/06/2005

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Switzerland

Trial participating centre

Petersgraben 4
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital of Basel (Switzerland)

Sponsor details

Departement of Internal Medicine
Petersgraben 4
Basel
4031
Switzerland
Muellerb@uhbs.ch

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Hospital Basel, Switzerland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Freie Medizinische Gesellschaft (FAG)

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