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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
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Gilles Boire, Université de Sherbrooke

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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
Other Names:
  • Risedronate
  • Alendronate




Primary Outcome Measures :
  1. Increase in bone density according to osteodensitometry [ Time Frame: Over 2 years of treatment ]
    comparing successive bone densitometry


Secondary Outcome Measures :
  1. Decrease in bone pain [ Time Frame: Over the first 2 years of treatment ]
    comparing reports of bone pain

  2. Retardation of scoliosis development [ Time Frame: Over the first 2 years of treatment ]
    computing how many patients had to have scoliosis surgery


Other Outcome Measures:
  1. Side effects of treatment [ Time Frame: Over 2 years ]
    Look for increases in kidney stones or hypercalciuria



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Gilles Boire
Procter and Gamble
Investigators
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Principal Investigator: Gilles Boire, MD, MSc CHUS and Université de Sherbrooke

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Responsible Party: Gilles Boire, Doctor Gilles Boire, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01882400     History of Changes
Other Study ID Numbers: 01-12
Unrestricted grant ( Other Grant/Funding Number: Procter&Gamble )
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Gilles Boire, Université de Sherbrooke:
Osteoporosis
Severe muscular dystrophy
Cystic fibrosis

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Osteoporosis
Muscular Dystrophies
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs