Cystic Fibrosis Clinical Trial
Official title:
Évaluation Multidimensionnelle de la réponse au Traitement de l'ostéoporose spontanée et Induite Par Les corticostéroïdes à l'Aide d'un Bisphosphonate à Administration Orale Chez Des Malades Porteurs d'Une Dystrophie Musculaire sévère.
Verified date | January 2018 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
By supplying an adequate amount of calcium and vitamin D with the addition of weekly
bisphosphonate, the investigators will be able to increase bone mass and decrease the
incidence of fragility fractures in these children with muscular dystrophy.
The investigators think this treatment will also decrease the intensity of pain frequently
present in these patients and slow the progression of scoliosis.
Status | Completed |
Enrollment | 11 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Osteoporosis or osteopenia - Severe muscular dystrophy or cystic fibrosis - May use corticosteroids Exclusion Criteria: - Inability to consent or to take drugs by mouth |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Gilles Boire | Procter and Gamble |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Side effects of treatment | Look for increases in kidney stones or hypercalciuria | Over 2 years | |
Primary | Increase in bone density according to osteodensitometry | comparing successive bone densitometry | Over 2 years of treatment | |
Secondary | Decrease in bone pain | comparing reports of bone pain | Over the first 2 years of treatment | |
Secondary | Retardation of scoliosis development | computing how many patients had to have scoliosis surgery | Over the first 2 years of treatment |
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