Trial | NCT00822029  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    2
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).
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.
Study Started
Feb 28
2009
Primary Completion
Feb 28
2011
Study Completion
Feb 28
2011
Last Update
Mar 26
2012
Estimate

Drug FOSAMAX

patient receiving one tablet (oral use) 70 mg Fosamax by week

Other PLACEBO

patient receiving one tablet (oral use) placebo by week

1 Experimental

FOSAMAX (oral bisphosphonate)

2 Placebo Comparator

PLACEBO

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
No Results Posted