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

NCT00822029 | Terminated Phase 3

• 1 other identifier: 2006-005678-36
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoporosis; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

FOSAMAX (oral bisphosphonate)

Drug: FOSAMAX

2

PLACEBO COMPARATOR

PLACEBO

Other: PLACEBO

Interventions

FOSAMAX DRUG

patient receiving one tablet (oral use) 70 mg Fosamax by week

1

PLACEBO OTHER

patient receiving one tablet (oral use) placebo by week

2

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Clinical Research and Innovation: lead

Study Sites (1)

Chirurgie Infantile - Hôpital ARCHET

Nice, 06003, France

Location

MeSH Terms

Conditions

Osteoporosis; Cerebral Palsy

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Jacques GRIFFET, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Departement of clinical research and innovation (drc)

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 26, 2012

Record last verified: 2011-11

Locations

FR (1)