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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00822029
• Other study ID #: 2006-005678-36
• Status: Terminated
• Phase: Phase 3
• First received: January 13, 2009
• Last updated: March 23, 2012
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Osteoporosis

Intervention

Drug:
• FOSAMAX
patient receiving one tablet (oral use) 70 mg Fosamax by week

Other:
• PLACEBO
patient receiving one tablet (oral use) placebo by week

Locations

Country	Name	City	State
France	Chirurgie Infantile - Hôpital ARCHET	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Department of Clinical Research and Innovation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry.		one year	No
Secondary	To estimate the improvement of the biological and clinical consequences (bone pains and fractures) of osteoporosis. To estimate the improvement of the quality of life To estimate the tolerance of oral bisphosphonates.		one year	Yes