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

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).

Study Overview

• Status: Terminated
• Conditions: Cerebral Palsy; Osteoporosis
• Intervention / Treatment: Drug: FOSAMAX; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Nice, France, 06003
    • Chirurgie Infantile - Hôpital ARCHET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; FOSAMAX (oral bisphosphonate)	Drug: FOSAMAX; patient receiving one tablet (oral use) 70 mg Fosamax by week
PLACEBO_COMPARATOR: 2; PLACEBO	Other: PLACEBO; patient receiving one tablet (oral use) placebo by week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry.	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Department of Clinical Research and Innovation
• Investigators: Principal Investigator: Jacques GRIFFET, PhD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (ESTIMATE): January 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Cerebral Palsy; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: 2006-005678-36