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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00822029
• Date of registration: 13/01/2009
• Prospective Registration: Yes
• Primary sponsor: Department of Clinical Research and Innovation
• Public title: Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
• Scientific title: Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
• Date of first enrolment: February 2009
• Target sample size: 2
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00822029
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Jacques GRIFFET, PhD
• Affiliation: CHU de Nice

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoporosis

Cerebral Palsy

Intervention(s)

Drug: FOSAMAX

Other: PLACEBO

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

2006-005678-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors