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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822029
First Posted: January 14, 2009
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
  Purpose
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
Osteoporosis Cerebral Palsy Drug: FOSAMAX Other: PLACEBO Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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 Department of Clinical Research and Innovation, 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)
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

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.

  Eligibility

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822029


Locations
France
Chirurgie Infantile - Hôpital ARCHET
Nice, France, 06003
Sponsors and Collaborators
Department of Clinical Research and Innovation
Investigators
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
ClinicalTrials.gov Identifier: NCT00822029     History of Changes
Other Study ID Numbers: 2006-005678-36
First Submitted: January 13, 2009
First Posted: January 14, 2009
Last Update Posted: March 26, 2012
Last Verified: November 2011

Additional relevant MeSH terms:
Osteoporosis
Paralysis
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
Diphosphonates
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs