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

Sponsor

Department of Clinical Research and Innovation (Other)

Overall Status

Terminated

CT.gov ID

NCT00822029

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Cerebral Palsy	Drug: FOSAMAX Other: PLACEBO	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

2 participants

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry. [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. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chirurgie Infantile - Hôpital ARCHET	Nice		France	06003

Sponsors and Collaborators

Department of Clinical Research and Innovation

Investigators

Principal Investigator: Jacques GRIFFET, PhD, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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

Other Study ID Numbers:

2006-005678-36

First Posted:

Jan 14, 2009

Last Update Posted:

Mar 26, 2012

Last Verified:

Nov 1, 2011

Additional relevant MeSH terms:

Osteoporosis

Cerebral Palsy

Alendronate

Study Results

No Results Posted as of Mar 26, 2012