Study Into the Effect of Pamidronate for the Prevention of Heterotopic Ossification in High-Risk Patients: A Randomized Controlled Trial
Not Applicable
Completed
- Conditions
- Established heterotopic ossificationMusculoskeletal DiseasesHeterotopic ossification
- Registration Number
- ISRCTN01332857
- Lead Sponsor
- niversity Hospital of Basel (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Consecutive patients with established HO (Brooker grade III-IV), hospitalized for resection of HO lesions
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the radiological HO recurrence rate
- Secondary Outcome Measures
Name Time Method Secondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers)