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 (NCT) | NCT00262392 |
| Protocol serial number | N/A |
| Sponsor | University Hospital of Basel (Switzerland) |
| Funders | University Hospital Basel, Switzerland, Freie Medizinische Gesellschaft (FAG) |
- 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
Scientific
Petersgraben 4
Basel
4031
Switzerland
| Schuetzp@uhbs.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, active-controlled, intervention trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Study Into the Effect of Pamidronate for the Prevention of Heterotopic Ossification in High-Risk Patients: A Randomized Controlled Trial |
| Study objectives | 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(s) | The trial was approved by the Ethics Committee of Basel (EKBB), reference number: 129/05 |
| Health condition(s) or problem(s) studied | Established heterotopic ossification |
| Intervention | Pamidronate (Aredia) versus radiation therapy |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pamidronate |
| Primary outcome measure(s) |
Primary endpoint is the radiological HO recurrence rate |
| Key secondary outcome measure(s) |
Secondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers) |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | Consecutive patients with established HO (Brooker grade III-IV), hospitalized for resection of HO lesions |
| Key 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 |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Petersgraben 4
Basel
4031
Switzerland
4031
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
01/02/2019: Clinicaltrials.gov states that this trial was withdrawn by September 2008
