Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy
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.
2 other identifiers
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2001
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedJanuary 9, 2018
January 1, 2018
6.3 years
June 17, 2013
January 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase in bone density according to osteodensitometry
comparing successive bone densitometry
Over 2 years of treatment
Secondary Outcomes (2)
Decrease in bone pain
Over the first 2 years of treatment
Retardation of scoliosis development
Over the first 2 years of treatment
Other Outcomes (1)
Side effects of treatment
Over 2 years
Study Arms (1)
Bisphosphonate treatment
EXPERIMENTALAdd a weekly bisphosphonate to adequate doses of calcium and vitamin D supplements
Interventions
Treatment with Calcium, vitamin D and a weekly bisphosphonate. Comparison of bone mass, fracture rate, pain intensity and scoliosis progression before and after treatment
Eligibility Criteria
You may qualify if:
- Osteoporosis or osteopenia
- Severe muscular dystrophy or cystic fibrosis
- May use corticosteroids
You may not qualify if:
- Inability to consent or to take drugs by mouth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilles Boirelead
- Procter and Gamblecollaborator
Study Sites (1)
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (1)
Jeffery TC, Chang AB, Conwell LS. Bisphosphonates for osteoporosis in people with cystic fibrosis. Cochrane Database Syst Rev. 2023 Jan 10;1(1):CD002010. doi: 10.1002/14651858.CD002010.pub5.
PMID: 36625789DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilles Boire, MD, MSc
CHUS and Université de Sherbrooke
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor Gilles Boire
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 20, 2013
Study Start
May 1, 2001
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
January 9, 2018
Record last verified: 2018-01