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

NCT ID: NCT00822029

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

FOSAMAX (oral bisphosphonate)

Group Type: EXPERIMENTAL

FOSAMAX

Intervention Type: DRUG

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

2

PLACEBO

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: OTHER

patient receiving one tablet (oral use) placebo by week

Interventions

FOSAMAX

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

Intervention Type: DRUG

PLACEBO

patient receiving one tablet (oral use) placebo by week

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Clinical Research and Innovation

OTHER

Sponsor Role: lead

Responsible Party

Department of Clinical Research and Innovation

Departement of clinical research and innovation (drc)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jacques GRIFFET, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

Chirurgie Infantile - Hôpital ARCHET

Nice, , France

Countries

France

Other Identifiers

2006-005678-36

Identifier Type: -

Identifier Source: org_study_id