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