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

Primary Purpose

Osteoporosis, Cerebral Palsy

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
FOSAMAX
PLACEBO
Sponsored by
Department of Clinical Research and Innovation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chirurgie Infantile - Hôpital ARCHET

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

FOSAMAX (oral bisphosphonate)

PLACEBO

Outcomes

Primary Outcome Measures

To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry.

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.

Full Information

First Posted
January 13, 2009
Last Updated
March 23, 2012
Sponsor
Department of Clinical Research and Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT00822029
Brief Title
Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
Official Title
Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
only 2 patients inclued and Study Principal Investigator has left the hospital
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Department of Clinical Research and Innovation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
FOSAMAX (oral bisphosphonate)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
PLACEBO
Intervention Type
Drug
Intervention Name(s)
FOSAMAX
Intervention Description
patient receiving one tablet (oral use) 70 mg Fosamax by week
Intervention Type
Other
Intervention Name(s)
PLACEBO
Intervention Description
patient receiving one tablet (oral use) placebo by week
Primary Outcome Measure Information:
Title
To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry.
Time Frame
one year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques GRIFFET, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chirurgie Infantile - Hôpital ARCHET
City
Nice
ZIP/Postal Code
06003
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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