OsteoporosisNCT05281120
Effects of Low-level Mechanical Vibration on Bone Density in Ambulant Children Affected by Duchenne Muscular Dystrophy
A study testing Low-level mechanical vibrations WITH vertical sinusoidal acceleration and Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration in people with Osteoporosis and Duchenne Muscular Dystrophy, run by Istituto Auxologico Italiano.
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. Read more about this study
- Who is it for?
- Ages 7 to 10 years, men only
- Conditions the study is for
- Osteoporosis, Duchenne Muscular Dystrophy
- What is being tested?
- Low-level mechanical vibrations WITH vertical sinusoidal acceleration and Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Presence of other diseases interfering with bone density and bone turnover
- The inability to regularly use the vibratory platform.
About this study
Official title: Low-level Mechanical Vibration, Bone Density, Bone Resorption and Muscular Strength 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.
Read the detailed 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.
- Conditions
- Osteoporosis, Duchenne Muscular Dystrophy
- Being tested
- Low-level mechanical vibrations WITH vertical sinusoidal acceleration, Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration
- Keywords
- Duchenne Muscular Dystrophy, children, low bone mass, osteoporosis, low-level mechanical vibration, bone turnover markers
- Medical subject headings
- Osteoporosis, Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level mechanical vibrations WITH vertical sinusoidal accelerationDevice
Small platform designed to induce vertical, sinusoidal acceleration.
Low-level mechanical vibrations WITHOUT vertical sinusoidal accelerationDevice
Small platform designed to NOT induce vertical, sinusoidal acceleration
| Study group | Role | What they receive |
|---|---|---|
| mechanical intervention group | Active comparator | 20 subjects participated to the study (1 year double-blind, randomized, placebo controlled, parallel group study) and 10 subjects were randomized to this arm.
Intervention: to stand on the active platform (inducing vertical, sinusoidal acceleration) for 10 minutes each day for 12 months. Receives: Device: Low-level mechanical vibrations WITH vertical sinusoidal acceleration |
| mechanical placebo group | Placebo comparator | 20 subjects participated to the study (1 year double-blind, randomized, placebo controlled, parallel group study) and 10 subjects were randomized to this arm.
Intervention: to stand on the placebo platform (not inducing vertical, sinusoidal acceleration) for 10 minutes each day for 12 months. Receives: Device: Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12th month
Secondary outcomes (9)
Calcium
changes in serum calcium (mg/dL)
Measured: baseline and 12th month
Phosphate
changes in serum phosphate (mg/dL)
Measured: baseline and 12th month
Magnesium
changes in serum magnesium (mg/dL)
Measured: baseline and 12th month
Creatinine
changes in serum creatinine (mg/dL)
Measured: baseline and 12th month
Bone Alkaline Phosphatase
changes in serum bone alkaline phosphatase (µg/L)
Measured: baseline and 12th month
Osteocalcin
changes in serum osteocalcin (µg/L)
Measured: baseline and 12th month
Parathyroid Hormone
changes in serum parathyroid hormone (ng/L)
Measured: baseline and 12th month
25-OH vitamin D
changes in serum 25-OH vitamin D (µg/L)
Measured: baseline and 12th month
1,25(OH)2 vitamin D
changes in serum 1,25(OH)2 vitamin D (ng/L)
Measured: baseline and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study startNov 2006
- Primary completionMay 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Bianchi, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281120
- Sponsor's protocol ID
- 02C701
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Khan MA. Corticosteroid therapy in Duchenne muscular dystrophy. J Neurol Sci. 1993 Dec 1;120(1):8-14. doi: 10.1016/0022-510x(93)90017-s.
PubMed 8289083Mendell JR, Moxley RT, Griggs RC, Brooke MH, Fenichel GM, Miller JP, King W, Signore L, Pandya S, Florence J, et al. Randomized, double-blind six-month trial of prednisone in Duchenne's muscular dystrophy. N Engl J Med. 1989 Jun 15;320(24):1592-7. doi: 10.1056/NEJM198906153202405.
PubMed 2657428Bonifati MD, Ruzza G, Bonometto P, Berardinelli A, Gorni K, Orcesi S, Lanzi G, Angelini C. A multicenter, double-blind, randomized trial of deflazacort versus prednisone in Duchenne muscular dystrophy. Muscle Nerve. 2000 Sep;23(9):1344-7. doi: 10.1002/1097-4598(200009)23:93.0.co;2-f.
PubMed 10951436Biggar WD, Gingras M, Fehlings DL, Harris VA, Steele CA. Deflazacort treatment of Duchenne muscular dystrophy. J Pediatr. 2001 Jan;138(1):45-50. doi: 10.1067/mpd.2001.109601.
PubMed 11148511Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993 Jun;94(6):646-50. doi: 10.1016/0002-9343(93)90218-e. No abstract available.
PubMed 8506892Baylink DJ. Glucocorticoid-induced osteoporosis. N Engl J Med. 1983 Aug 4;309(5):306-8. doi: 10.1056/NEJM198308043090509. No abstract available.
PubMed 6866054Chesney RW, Mazess RB, Rose P, Jax DK. Effect of prednisone on growth and bone mineral content in childhood glomerular disease. Am J Dis Child. 1978 Aug;132(8):768-72. doi: 10.1001/archpedi.1978.02120330040010.
PubMed 685891Jones G, Ponsonby AL, Smith BJ, Carmichael A. Asthma, inhaled corticosteroid use, and bone mass in prepubertal children. J Asthma. 2000;37(7):603-11. doi: 10.3109/02770900009090816.
PubMed 11059528Naganathan V, Jones G, Nash P, Nicholson G, Eisman J, Sambrook PN. Vertebral fracture risk with long-term corticosteroid therapy: prevalence and relation to age, bone density, and corticosteroid use. Arch Intern Med. 2000 Oct 23;160(19):2917-22. doi: 10.1001/archinte.160.19.2917.
PubMed 11041898Whalen RT, Carter DR, Steele CR. Influence of physical activity on the regulation of bone density. J Biomech. 1988;21(10):825-37. doi: 10.1016/0021-9290(88)90015-2.
PubMed 3225269Slemenda CW, Miller JZ, Hui SL, Reister TK, Johnston CC Jr. Role of physical activity in the development of skeletal mass in children. J Bone Miner Res. 1991 Nov;6(11):1227-33. doi: 10.1002/jbmr.5650061113.
PubMed 1805545Slemenda CW, Reister TK, Hui SL, Miller JZ, Christian JC, Johnston CC Jr. Influences on skeletal mineralization in children and adolescents: evidence for varying effects of sexual maturation and physical activity. J Pediatr. 1994 Aug;125(2):201-7. doi: 10.1016/s0022-3476(94)70193-8.
PubMed 8040762Courteix D, Lespessailles E, Peres SL, Obert P, Germain P, Benhamou CL. Effect of physical training on bone mineral density in prepubertal girls: a comparative study between impact-loading and non-impact-loading sports. Osteoporos Int. 1998;8(2):152-8. doi: 10.1007/BF02672512.
PubMed 9666939Palmieri GM, Bertorini TE, Griffin JW, Igarashi M, Karas JG. Assessment of whole body composition with dual energy x-ray absorptiometry in Duchenne muscular dystrophy: correlation of lean body mass with muscle function. Muscle Nerve. 1996 Jun;19(6):777-9. doi: 10.1002/(SICI)1097-4598(199606)19:63.0.CO;2-I. No abstract available.
PubMed 8609931Larson CM, Henderson RC. Bone mineral density and fractures in boys with Duchenne muscular dystrophy. J Pediatr Orthop. 2000 Jan-Feb;20(1):71-4.
PubMed 10641693
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Mechanical Vibration, Bone Density, Bone Resorption and Muscular Strength in Ambulant Children Affected by Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05281120
- Acronym / sponsor ID
- 02C701
- Conditions
- Osteoporosis, Duchenne Muscular Dystrophy
- Keywords
- Duchenne Muscular Dystrophy, children, low bone mass, osteoporosis, low-level mechanical vibration, bone turnover markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mechanical intervention group | Active comparator | Device: Low-level mechanical vibrations WITH vertical sinusoidal acceleration20 subjects participated to the study (1 year double-blind, randomized, placebo controlled, parallel group study) and 10 subjects were randomized to this arm. Intervention: to stand on the active platform (inducing vertical, sinusoidal acceleration) for 10 minutes each day for 12 months. |
| mechanical placebo group | Placebo comparator | Device: Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration20 subjects participated to the study (1 year double-blind, randomized, placebo controlled, parallel group study) and 10 subjects were randomized to this arm. Intervention: to stand on the placebo platform (not inducing vertical, sinusoidal acceleration) for 10 minutes each day for 12 months. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of other diseases interfering with bone density and bone turnover
- The inability to regularly use the vibratory platform.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level mechanical vibrations WITH vertical sinusoidal accelerationSmall platform designed to induce vertical, sinusoidal acceleration. | Device | mechanical intervention group |
| Low-level mechanical vibrations WITHOUT vertical sinusoidal accelerationSmall platform designed to NOT induce vertical, sinusoidal acceleration | Device | mechanical placebo group |
Primary outcome
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.
9 secondary outcomes
Calcium
Time frame: baseline and 12th month
Phosphate
Time frame: baseline and 12th month
Magnesium
Time frame: baseline and 12th month
Creatinine
Time frame: baseline and 12th month
Bone Alkaline Phosphatase
Time frame: baseline and 12th month
Osteocalcin
Time frame: baseline and 12th month
Parathyroid Hormone
Time frame: baseline and 12th month
25-OH vitamin D
Time frame: baseline and 12th month
1,25(OH)2 vitamin D
Time frame: baseline and 12th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 8289083Khan MA. Corticosteroid therapy in Duchenne muscular dystrophy. J Neurol Sci. 1993 Dec 1;120(1):8-14. doi: 10.1016/0022-510x(93)90017-s.
- Background: PubMed 2657428Mendell JR, Moxley RT, Griggs RC, Brooke MH, Fenichel GM, Miller JP, King W, Signore L, Pandya S, Florence J, et al. Randomized, double-blind six-month trial of prednisone in Duchenne's muscular dystrophy. N Engl J Med. 1989 Jun 15;320(24):1592-7. doi: 10.1056/NEJM198906153202405.
- Background: PubMed 10951436Bonifati MD, Ruzza G, Bonometto P, Berardinelli A, Gorni K, Orcesi S, Lanzi G, Angelini C. A multicenter, double-blind, randomized trial of deflazacort versus prednisone in Duchenne muscular dystrophy. Muscle Nerve. 2000 Sep;23(9):1344-7. doi: 10.1002/1097-4598(200009)23:93.0.co;2-f.
- Background: PubMed 11148511Biggar WD, Gingras M, Fehlings DL, Harris VA, Steele CA. Deflazacort treatment of Duchenne muscular dystrophy. J Pediatr. 2001 Jan;138(1):45-50. doi: 10.1067/mpd.2001.109601.
- Background: PubMed 8506892Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993 Jun;94(6):646-50. doi: 10.1016/0002-9343(93)90218-e. No abstract available.
- Background: PubMed 6866054Baylink DJ. Glucocorticoid-induced osteoporosis. N Engl J Med. 1983 Aug 4;309(5):306-8. doi: 10.1056/NEJM198308043090509. No abstract available.
- Background: PubMed 685891Chesney RW, Mazess RB, Rose P, Jax DK. Effect of prednisone on growth and bone mineral content in childhood glomerular disease. Am J Dis Child. 1978 Aug;132(8):768-72. doi: 10.1001/archpedi.1978.02120330040010.
- Background: PubMed 11059528Jones G, Ponsonby AL, Smith BJ, Carmichael A. Asthma, inhaled corticosteroid use, and bone mass in prepubertal children. J Asthma. 2000;37(7):603-11. doi: 10.3109/02770900009090816.
- Background: PubMed 11041898Naganathan V, Jones G, Nash P, Nicholson G, Eisman J, Sambrook PN. Vertebral fracture risk with long-term corticosteroid therapy: prevalence and relation to age, bone density, and corticosteroid use. Arch Intern Med. 2000 Oct 23;160(19):2917-22. doi: 10.1001/archinte.160.19.2917.
- Background: PubMed 3225269Whalen RT, Carter DR, Steele CR. Influence of physical activity on the regulation of bone density. J Biomech. 1988;21(10):825-37. doi: 10.1016/0021-9290(88)90015-2.
- Background: PubMed 1805545Slemenda CW, Miller JZ, Hui SL, Reister TK, Johnston CC Jr. Role of physical activity in the development of skeletal mass in children. J Bone Miner Res. 1991 Nov;6(11):1227-33. doi: 10.1002/jbmr.5650061113.
- Background: PubMed 8040762Slemenda CW, Reister TK, Hui SL, Miller JZ, Christian JC, Johnston CC Jr. Influences on skeletal mineralization in children and adolescents: evidence for varying effects of sexual maturation and physical activity. J Pediatr. 1994 Aug;125(2):201-7. doi: 10.1016/s0022-3476(94)70193-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luisa Bianchi principal investigator
Istituto Auxologico Italiano
Questions about this trial
What is this clinical trial studying?
A study testing Low-level mechanical vibrations WITH vertical sinusoidal acceleration and Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration in people with Osteoporosis and Duchenne Muscular Dystrophy, run by Istituto Auxologico Italiano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density at lumbar spine. (time frame: baseline and 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281120, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.