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

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Department of Clinical Research and Innovation
• Treatments: Alendronate; Diphosphonates

Criteria

Inclusion Criteria:

• non-walking children with cerebral palsy

• weight > to or = 20 kg

• aged between 10 to 18 years old

• with a Z-score (spinal and / or femoral) <-2 DS

• with a good dental status

• capable of holding the seated or half seated position for 30 minutes

• capable of filling the study questionary

• with negative blood pregnancy tests on inclusion for pubescent girls

• Using valid contraception means (condoms, oral contraception) for pubescent girls for the whole study duration and 6 months after the end of the study

• affiliated to the social security regimen

Exclusion Criteria:

• history of spine arthrodesis with osteosynthesis

• gastro-oesophageal reflux

• oesophagal disease or any factor leading to a delaying or slowing the oesophagal transit (such as stenosis or achalasy)

• severe difficulties in swallowing

• renal failure

• history of uveitis

• hypersensibility to alendronate or to one of its excipients (microcristalline cellulose, lactose anhydre, croscarmellose sodium, magnesium stearate)

• deficiency in calcium or in vitamine D

• calcium malabsorption

• hereditary galactose intolerance, congenital galactosemia, glucose and galactose malabsorption syndrome

• evolutive affection of the upper gastro-intestinal tract such as dysphagia (other than neurological), gastritis, duodenitis, gastro-duodenal ulcers (or with history of ulcers in the previous year), evolutive gastro-intestinal bleeding or history of surgery of the upper gastro-intestinal tract (gastrostomy in particular)

• history of necrosis of the maxillar bone or of uncovering of the bone or of cicatrisation delay after a dental surgery

• emancipated minor

• prior treatment with bisphosphonates

• inclusion in another clinical research study