NCT00822029

Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Department of Clinical Research and Innovation · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

It is a double blind randomized study aiming at estimating the efficiency of oral bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric values between two groups of children (treatment versus placebo).

Detailed description

In non walking children with cerebral palsy, osteoporosis is responsible for bone pains and iterative fractures. Classical treatments include physiotherapy, assisted verticalisation by orthesis and correct feeding with vitamin D and calcium supplementation. Yet this isn't always sufficient and isn't always possible. Bisphosphonates, which have been used for years in the treatment of post-menopausic osteoporosis or of osteogenesis imperfecta in children, can turn out to be very useful for non-walking children with cerebral palsy. Studies have been published since 1994 in this indication with encouraging results. Cyclic intravenous administration of bisphosphonates every 3 months showed an objective increase in bone density and a decrease in pains and fractures after one year of treatment. Cyclic intravenous administration nevertheless requires the use of an implanted chamber and iterative hospitalizations. Oral administration should allow to treat these children, who already have many treatments, in a simpler way. The study will concern 40 non-walking children with cerebral palsy aged over 10 years.

Conditions

• Osteoporosis
• Cerebral Palsy

Interventions

Type	Name	Description
DRUG	FOSAMAX	patient receiving one tablet (oral use) 70 mg Fosamax by week
OTHER	PLACEBO	patient receiving one tablet (oral use) placebo by week

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-01-14
• Last updated: 2012-03-26

Locations

1 site across 1 country: France