Study Into the Effect of Pamidronate for the Prevention of Heterotopic Ossification in High-Risk Patients: A Randomized Controlled Trial

ISRCTN ISRCTN01332857
DOI https://doi.org/10.1186/ISRCTN01332857
ClinicalTrials.gov number NCT00262392
Secondary identifying numbers N/A
Submission date
26/01/2006
Registration date
06/03/2006
Last edited
01/02/2019
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Philipp Schuetz
Scientific

Petersgraben 4
Basel
4031
Switzerland

Email Schuetzp@uhbs.ch

Study information

Study designProspective, active-controlled, intervention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleStudy Into the Effect of Pamidronate for the Prevention of Heterotopic Ossification in High-Risk Patients: A Randomized Controlled Trial
Study objectivesThe 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(s)The trial was approved by the Ethics Committee of Basel (EKBB), reference number: 129/05
Health condition(s) or problem(s) studiedEstablished heterotopic ossification
InterventionPamidronate (Aredia) versus radiation therapy
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Pamidronate
Primary outcome measurePrimary endpoint is the radiological HO recurrence rate
Secondary outcome measuresSecondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers)
Overall study start date01/06/2005
Completion date01/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteriaConsecutive patients with established HO (Brooker grade III-IV), hospitalized for resection of HO lesions
Key exclusion criteria1. 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
Date of first enrolment01/06/2005
Date of final enrolment01/06/2008

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Petersgraben 4
Basel
4031
Switzerland

Sponsor information

University Hospital of Basel (Switzerland)
University/education

Departement of Internal Medicine
Petersgraben 4
Basel
4031
Switzerland

Email Muellerb@uhbs.ch
ROR logo "ROR" https://ror.org/04k51q396

Funders

Funder type

University/education

University Hospital Basel, Switzerland

No information available

Freie Medizinische Gesellschaft (FAG)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

01/02/2019: Clinicaltrials.gov states that this trial was withdrawn by September 2008