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Completed

NCT Number: NCT01882400

Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Risedronate, Alendronate

Primary outcomes

  1. Increase in bone density according to osteodensitometry

    Time frame: Over 2 years of treatment

    comparing successive bone densitometry

Secondary outcomes

  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 outcomes

  1. Side effects of treatment

    Time frame: Over 2 years

    Look for increases in kidney stones or hypercalciuria

Sponsors and collaborators

Lead sponsor

Gilles Boire

Other

Collaborators

  • Procter and Gamble

Registry information

Official study 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.

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Jun 20, 2013
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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