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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281120
• Other study ID #: 02C701
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2022
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Osteoporosis

Intervention

Device:
• Low-level mechanical vibrations WITH vertical sinusoidal acceleration
Small platform designed to induce vertical, sinusoidal acceleration.
• Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration
Small platform designed to NOT induce vertical, sinusoidal acceleration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral density at lumbar spine.	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.	baseline and 12th month
Secondary	Calcium	changes in serum calcium (mg/dL)	baseline and 12th month
Secondary	Phosphate	changes in serum phosphate (mg/dL)	baseline and 12th month
Secondary	Magnesium	changes in serum magnesium (mg/dL)	baseline and 12th month
Secondary	Creatinine	changes in serum creatinine (mg/dL)	baseline and 12th month
Secondary	Bone Alkaline Phosphatase	changes in serum bone alkaline phosphatase (µg/L)	baseline and 12th month
Secondary	Osteocalcin	changes in serum osteocalcin (µg/L)	baseline and 12th month
Secondary	Parathyroid Hormone	changes in serum parathyroid hormone (ng/L)	baseline and 12th month
Secondary	25-OH vitamin D	changes in serum 25-OH vitamin D (µg/L)	baseline and 12th month
Secondary	1,25(OH)2 vitamin D	changes in serum 1,25(OH)2 vitamin D (ng/L)	baseline and 12th month