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Completed

NCT Number: NCT05281120

Effects of Low-level Mechanical Vibration on Bone Density in Ambulant Children Affected by Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a X-linked recessive disorder due to a mutation of the dystrophin gene (Xp21). Dystrophin is a sarcolemmal protein of skeletal and cardiac muscle, and its absence causes progressive muscle degeneration and substitution with fat and connective tissue. The progressive muscle degeneration leads to loss of autonomous walking before the age of 15 years and death for cardiac and/or respiratory failure. There are no specific treatment for DMD, and the standard of care is now based on long-term corticosteroid (CS) use. The studies on bone mass in DMD are very few, but they agree in reporting the presence of a reduced bone mass and an increased rate of fractures probably due to long-term steroid therapy and disuse-osteopenia. The aim of this study, involving 20 ambulant DMD boys (age 7-10 years) has been the evaluation of the effects of low-level mechanical vibrations on bone in a group of ambulant DMD children for 1 year, with RDA-adjusted dietary calcium intake and 25OH vitamin D supplementation.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Duchenne Muscular Dystrophy Genetic Diseases, Inborn Genetic Diseases, X-Linked Metabolic Diseases Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases

Age range

7 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

All children were instructed to have a daily intake of calcium equal to the 100% of the RDA and were supplemented with calcifediol (0.7 mcg/kg/die).

The 20 boys were randomly assigned to two groups:

group 1 (mechanical intervention group) = a mechanical device (a small platform designed to induce vertical, sinusoidal acceleration) was installed in the home of each boy of group 1.

group 2 (placebo control group) = a placebo device was installed in the home of each boy of group 2

All boys were instructed to stand on the platform for 10 minutes each day for 12 months.

Compliance was followed and stimulated through weekly telephone contacts with parents and children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of DMD
  • Ability to stand up and walk (some balance assistance allowed, but full weight-bearing necessary)
  • All the children must already be on glucocorticoid therapy for at least 6 months before the start of the study.

Exclusion criteria

  • Presence of other diseases interfering with bone density and bone turnover
  • The inability to regularly use the vibratory platform.

Treatment and study plan

Low-level mechanical vibrations WITH vertical sinusoidal acceleration

Device

Small platform designed to induce vertical, sinusoidal acceleration.

Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration

Device

Small platform designed to NOT induce vertical, sinusoidal acceleration

Primary outcomes

  1. Change in bone mineral density at lumbar spine.

    Time frame: baseline and 12th month

    Bone mineral density evaluated by DXA. Bone mineral apparent density calculated to correct for bone size (growing subjects). Z-score calculated.

    Measurements: baseline and 12 months.

Secondary outcomes

  1. Calcium

    Time frame: baseline and 12th month

    changes in serum calcium (mg/dL)

  2. Phosphate

    Time frame: baseline and 12th month

    changes in serum phosphate (mg/dL)

  3. Magnesium

    Time frame: baseline and 12th month

    changes in serum magnesium (mg/dL)

  4. Creatinine

    Time frame: baseline and 12th month

    changes in serum creatinine (mg/dL)

  5. Bone Alkaline Phosphatase

    Time frame: baseline and 12th month

    changes in serum bone alkaline phosphatase (µg/L)

  6. Osteocalcin

    Time frame: baseline and 12th month

    changes in serum osteocalcin (µg/L)

  7. Parathyroid Hormone

    Time frame: baseline and 12th month

    changes in serum parathyroid hormone (ng/L)

  8. 25-OH vitamin D

    Time frame: baseline and 12th month

    changes in serum 25-OH vitamin D (µg/L)

  9. 1,25(OH)2 vitamin D

    Time frame: baseline and 12th month

    changes in serum 1,25(OH)2 vitamin D (ng/L)

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Low-level Mechanical Vibration, Bone Density, Bone Resorption and Muscular Strength in Ambulant Children Affected by Duchenne Muscular Dystrophy

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

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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