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

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ClinicalTrials.gov Identifier: NCT00822029
Recruitment Status : Terminated (only 2 patients inclued and Study Principal Investigator has left the hospital)
First Posted : January 14, 2009
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE January 13, 2009
First Posted Date  ICMJE January 14, 2009
Last Update Posted Date March 26, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry. [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
Official Title  ICMJE Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Cerebral Palsy
Intervention  ICMJE
  • Drug: FOSAMAX
    patient receiving one tablet (oral use) 70 mg Fosamax by week
  • Other: PLACEBO
    patient receiving one tablet (oral use) placebo by week
Study Arms  ICMJE
  • Experimental: 1
    FOSAMAX (oral bisphosphonate)
    Intervention: Drug: FOSAMAX
  • Placebo Comparator: 2
    PLACEBO
    Intervention: Other: PLACEBO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 27, 2011)
2
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2009)
40
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00822029
Other Study ID Numbers  ICMJE 2006-005678-36
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Department of Clinical Research and Innovation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques GRIFFET, PhD Centre Hospitalier Universitaire de Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP