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:
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00822029
First received: January 13, 2009
Last updated: March 23, 2012
Last verified: November 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 13, 2009
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Cerebral Palsy
Osteoporosis
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms
Diphosphonates
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014