Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy
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|ClinicalTrials.gov Identifier: NCT01882400|
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : January 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Muscular Dystrophy Cystic Fibrosis||Drug: Bisphosphonate treatment||Phase 4|
Children with muscular dystrophy, as well as children with other chronic diseases (e.g. cystic fibrosis, chronic inflammatory arthritis) are at risk to develop fragility fractures both due to the disease itself and to drugs (mostly corticosteroids) used to treat the diseases.
In addition, children with muscular dystrophy frequently complain of diffuse pain making daily care more difficult and almost always develop structural scoliosis.
The objective of the present protocol is to offer these children a preventive treatment aimed at maintaining or increasing their bone mass. We also propose that maintaining bone mass will decrease fracture rates, as well as pain and the rate of progression of scoliosis.
Rigorous care to ensure adequate intake of calcium and vitamin D, as well as addition of a weekly bisphosphonate, are the central aspect of the project. In addition, we will monitor to avoid possible side-effects such as hypercalciuria and kidney stones.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2001|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
Experimental: Bisphosphonate treatment
Add a weekly bisphosphonate to adequate doses of calcium and vitamin D supplements
Drug: Bisphosphonate treatment
Treatment with Calcium, vitamin D and a weekly bisphosphonate. Comparison of bone mass, fracture rate, pain intensity and scoliosis progression before and after treatment
- Increase in bone density according to osteodensitometry [ Time Frame: Over 2 years of treatment ]comparing successive bone densitometry
- Decrease in bone pain [ Time Frame: Over the first 2 years of treatment ]comparing reports of bone pain
- Retardation of scoliosis development [ Time Frame: Over the first 2 years of treatment ]computing how many patients had to have scoliosis surgery
- Side effects of treatment [ Time Frame: Over 2 years ]Look for increases in kidney stones or hypercalciuria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882400
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Gilles Boire, MD, MSc||CHUS and Université de Sherbrooke|