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| ID | Type | Description | Link |
|---|---|---|---|
| Unrestricted grant | Other Grant/Funding Number | Procter&Gamble |
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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisphosphonate treatment | Experimental | Add a weekly bisphosphonate to adequate doses of calcium and vitamin D supplements |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisphosphonate treatment | Drug | Treatment with Calcium, vitamin D and a weekly bisphosphonate. Comparison of bone mass, fracture rate, pain intensity and scoliosis progression before and after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in bone density according to osteodensitometry | comparing successive bone densitometry | Over 2 years of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in bone pain | comparing reports of bone pain | Over the first 2 years of treatment |
| Retardation of scoliosis development | computing how many patients had to have scoliosis surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects of treatment | Look for increases in kidney stones or hypercalciuria | Over 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Boire, MD, MSc | CHUS and Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36625789 | Derived | 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. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D009136 | Muscular Dystrophies |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| Over the first 2 years of treatment |
| D009750 |
| Nutritional and Metabolic Diseases |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |