The effect of pamidronate treatment on bone health in patients with neuromuscular disease undergoing hip surgery. - Using pamidronate in patients with CP undergoing hip surgery.
Phase 1
- Conditions
- Children with neuromuscular conditions undergoing hip surgery. Aiming to identify whether pamidronate a licenced medicine mainatins bone mineral density in patients with neuromuscular conditions undergoing hip surgery.
- Registration Number
- EUCTR2009-013777-17-GB
- Lead Sponsor
- Central Manchester and Manchester University Children's Hospital NHS Trust.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
All children with neuromuscular conditions between ages 6 and 16 undergoing hip surgery and post-op immobilisation in a hip spica at Royal Manchester Children's Hospital.
Exclusion criteria: Failure at screening. Not willing to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To find out whether pre-operative pamidronate treatment in children with neuromuscular disorders undergoing hip surgery improves their bone strength as compared with a controlled group. ;Secondary Objective: ;Primary end point(s): Bone Mineral Content (BMC) and Bone Mineral Density (BMD) three months following surgery.
- Secondary Outcome Measures
Name Time Method