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

This study has been terminated.
(only 2 patients inclued and Study Principal Investigator has left the hospital)
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice Identifier:
First received: January 13, 2009
Last updated: March 23, 2012
Last verified: November 2011
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).

Condition Intervention Phase
Cerebral Palsy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry. [ Time Frame: one year ]

Secondary Outcome Measures:
  • 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. [ Time Frame: one year ]

Enrollment: 2
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FOSAMAX (oral bisphosphonate)
patient receiving one tablet (oral use) 70 mg Fosamax by week
Placebo Comparator: 2
patient receiving one tablet (oral use) placebo by week

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.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00822029

Chirurgie Infantile - Hôpital ARCHET
Nice, France, 06003
Sponsors and Collaborators
Department of Clinical Research and Innovation
Principal Investigator: Jacques GRIFFET, PhD CHU de Nice
  More Information

Responsible Party: Department of Clinical Research and Innovation, Departement of clinical research and innovation (drc), Centre Hospitalier Universitaire de Nice Identifier: NCT00822029     History of Changes
Other Study ID Numbers: 2006-005678-36
Study First Received: January 13, 2009
Last Updated: March 23, 2012

Additional relevant MeSH terms:
Cerebral Palsy
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 27, 2017