OsteopeniaNCT00396994
"VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density
A study testing Low magnitude mechanical stimulation in people with Osteopenia, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Low magnitude mechanical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2012
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 60 years and over of all ethnic groups
- Weight less than 250 pounds
- Absence of terminal cancer or other illness necessitating hospice level services
- Capable of following the protocol and of understanding and providing informed consent
- Scoring less than 12 on the Short Blessed Test
Who cannot join
- Immobilization of the axial or lower appendicular skeleton within the last year
- Nonambulatory (ambulation with an assistive device will be permitted)
- Malignancy other than cured thyroid cancer or skin cancer
- Hip replacement or internal fixation, total knee replacement, or lower limb fracture within the past year, or bilateral hip replacement
- Medications: glucocorticoids, suppressive doses of thyroid hormone as determined by screening TSH, anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), estrogen/testosterone replacement, selective estrogen receptor modulators (SERMs), PTH, or bisphosphonates more than 1 month in past year, calcitonin therapy within the preceding month, fluoride therapy at any time
- Paget's disease of bone, rheumatoid arthritis or other connective tissue disorders requiring systemic treatment with disease modifying drugs, or a history of Cushing's syndrome
- Fragility fracture within the past five years unless pharmacologic therapy not to be prescribed
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew SeniorLife, Institute for Aging Research
Boston, Massachusetts, 02131
About this study
Official title: Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.
Read the detailed description
The treatment options for osteoporosis, a major health complication in the aged population, are limited to pharmacologic interventions, the majority of which are antiresorptive. Preliminary data demonstrate that high frequency, low magnitude mechanical stimulation (LMMS) can preserve bone mineral density (BMD) by preventing bone resorption due to disuse and aging, and can stimulate new bone formation.
To confirm and extend these observations, this study is a three-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (60 years of age and older). A clinical center located in Boston, MA has recruited participants from multiple independent living facilities in close geographic proximity. Participants meeting the inclusion/exclusion criteria have been randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a three year period. All participants receive 1000 mg of elemental calcium and 800 IU of vitamin D per day.
This study will provide new and important information about the role of low magnitude high frequency mechanical stimulation on the skeleton.
- Conditions
- Osteopenia
- Being tested
- Low magnitude mechanical stimulation, Sham low magnitude mechanical stimulation
- Keywords
- biomechanics, osteogenesis, osteoporosis, bone regeneration
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low magnitude mechanical stimulationDevice
10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz
Sham low magnitude mechanical stimulationDevice
10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform
| Study group | Role | What they receive |
|---|---|---|
| Low magnitude mechanical stimulation | Experimental | 10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz Receives: Device: Low magnitude mechanical stimulation |
| 2 | Placebo comparator | 10 minutes per day standing on sham low mechanical stimulation platform Receives: Device: Sham low magnitude mechanical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)
Measured: 2 - 3 years
Secondary outcomes (4)
Changes in biochemical markers of bone formation (Procollagen type 1 N-terminal peptide and Bone Specific Alkaline Phosphatase) and resorption (C-terminal Telopeptide of type I collagen)
Measured: 2 - 3 years
Changes in postural stability
Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform
Measured: 2 - 3 years
Changes in isometric leg extension strength
Isometric knee extension strength of the right leg measured with a handheld dynamometer
Measured: 2 - 3 years
Change in hip muscle area and density
Muscle area and density surrounding the hips measured by quantitative computed tomography
Measured: 2 - 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startFeb 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Douglas Kiel, Hebrew SeniorLife
- Investigators
- Douglas P. Kiel, MD, MPH, Principal investigator, Institute for Aging Research, Hebrew SeniorLifeMarian T. Hannan, DSc, MPH, Principal investigator, Institute for Aging Research, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396994
- Sponsor's protocol ID
- AG0071
- Other IDs
- R01AG025489
- Status last verified
- Mar 2013
- First submitted
- 7 Nov 2006
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ward K, Alsop C, Caulton J, Rubin C, Adams J, Mughal Z. Low magnitude mechanical loading is osteogenic in children with disabling conditions. J Bone Miner Res. 2004 Mar;19(3):360-9. doi: 10.1359/JBMR.040129. Epub 2004 Jan 27.
PubMed 15040823Rubin C, Recker R, Cullen D, Ryaby J, McCabe J, McLeod K. Prevention of postmenopausal bone loss by a low-magnitude, high-frequency mechanical stimuli: a clinical trial assessing compliance, efficacy, and safety. J Bone Miner Res. 2004 Mar;19(3):343-51. doi: 10.1359/JBMR.0301251. Epub 2003 Dec 22.
PubMed 15040821Gilsanz V, Wren TA, Sanchez M, Dorey F, Judex S, Rubin C. Low-level, high-frequency mechanical signals enhance musculoskeletal development of young women with low BMD. J Bone Miner Res. 2006 Sep;21(9):1464-74. doi: 10.1359/jbmr.060612.
PubMed 16939405Kiel DP, Hannan MT, Barton BA, Bouxsein ML, Lang TF, Brown KM, Shane E, Magaziner J, Zimmerman S, Rubin CT. Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health. Clin Trials. 2010 Aug;7(4):354-67. doi: 10.1177/1740774510371014. Epub 2010 Jun 22.
PubMed 20571129Muir JW, Kiel DP, Hannan M, Magaziner J, Rubin CT. Dynamic parameters of balance which correlate to elderly persons with a history of falls. PLoS One. 2013 Aug 5;8(8):e70566. doi: 10.1371/journal.pone.0070566. Print 2013.
PubMed 23940592Jeffrey BA, Hannan MT, Quinn EK, Zimmerman S, Barton BA, Rubin CT, Kiel DP. Self-reported adherence with the use of a device in a clinical trial as validated by electronic monitors: the VIBES study. BMC Med Res Methodol. 2012 Nov 14;12:171. doi: 10.1186/1471-2288-12-171.
PubMed 23150931
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
- ClinicalTrials.gov ID
- NCT00396994
- Acronym / sponsor ID
- AG0071
- Conditions
- Osteopenia
- Keywords
- biomechanics, osteogenesis, osteoporosis, bone regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Nov 2006 (estimated)
- 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.
The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.
Detailed description
The treatment options for osteoporosis, a major health complication in the aged population, are limited to pharmacologic interventions, the majority of which are antiresorptive. Preliminary data demonstrate that high frequency, low magnitude mechanical stimulation (LMMS) can preserve bone mineral density (BMD) by preventing bone resorption due to disuse and aging, and can stimulate new bone formation.
To confirm and extend these observations, this study is a three-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (60 years of age and older). A clinical center located in Boston, MA has recruited participants from multiple independent living facilities in close geographic proximity. Participants meeting the inclusion/exclusion criteria have been randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a three year period. All participants receive 1000 mg of elemental calcium and 800 IU of vitamin D per day.
This study will provide new and important information about the role of low magnitude high frequency mechanical stimulation on the skeleton.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low magnitude mechanical stimulation | Experimental | Device: Low magnitude mechanical stimulation10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz |
| 2 | Placebo comparator | Device: Sham low magnitude mechanical stimulation10 minutes per day standing on sham low mechanical stimulation platform |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 60 years and over of all ethnic groups
- Weight less than 250 pounds
- Absence of terminal cancer or other illness necessitating hospice level services
- Capable of following the protocol and of understanding and providing informed consent
- Scoring less than 12 on the Short Blessed Test
Key exclusion criteria (7 listed)
- Immobilization of the axial or lower appendicular skeleton within the last year
- Nonambulatory (ambulation with an assistive device will be permitted)
- Malignancy other than cured thyroid cancer or skin cancer
- Hip replacement or internal fixation, total knee replacement, or lower limb fracture within the past year, or bilateral hip replacement
- Medications: glucocorticoids, suppressive doses of thyroid hormone as determined by screening TSH, anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), estrogen/testosterone replacement, selective estrogen receptor modulators (SERMs), PTH, or bisphosphonates more than 1 month in past year, calcitonin therapy within the preceding month, fluoride therapy at any time
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 magnitude mechanical stimulation10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz | Device | Low magnitude mechanical stimulation |
| Sham low magnitude mechanical stimulation10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform | Device | 2 |
Primary outcome
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)
Time frame: 2 - 3 years
4 secondary outcomes
Changes in biochemical markers of bone formation (Procollagen type 1 N-terminal peptide and Bone Specific Alkaline Phosphatase) and resorption (C-terminal Telopeptide of type I collagen)
Time frame: 2 - 3 years
Changes in postural stability
Time frame: 2 - 3 years
Changes in isometric leg extension strength
Time frame: 2 - 3 years
Change in hip muscle area and density
Time frame: 2 - 3 years
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 20 Mar 2013.
- Background: PubMed 15040823Ward K, Alsop C, Caulton J, Rubin C, Adams J, Mughal Z. Low magnitude mechanical loading is osteogenic in children with disabling conditions. J Bone Miner Res. 2004 Mar;19(3):360-9. doi: 10.1359/JBMR.040129. Epub 2004 Jan 27.
- Background: PubMed 15040821Rubin C, Recker R, Cullen D, Ryaby J, McCabe J, McLeod K. Prevention of postmenopausal bone loss by a low-magnitude, high-frequency mechanical stimuli: a clinical trial assessing compliance, efficacy, and safety. J Bone Miner Res. 2004 Mar;19(3):343-51. doi: 10.1359/JBMR.0301251. Epub 2003 Dec 22.
- Background: PubMed 16939405Gilsanz V, Wren TA, Sanchez M, Dorey F, Judex S, Rubin C. Low-level, high-frequency mechanical signals enhance musculoskeletal development of young women with low BMD. J Bone Miner Res. 2006 Sep;21(9):1464-74. doi: 10.1359/jbmr.060612.
- Background: PubMed 20571129Kiel DP, Hannan MT, Barton BA, Bouxsein ML, Lang TF, Brown KM, Shane E, Magaziner J, Zimmerman S, Rubin CT. Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health. Clin Trials. 2010 Aug;7(4):354-67. doi: 10.1177/1740774510371014. Epub 2010 Jun 22.
- Derived from this study: PubMed 23940592Muir JW, Kiel DP, Hannan M, Magaziner J, Rubin CT. Dynamic parameters of balance which correlate to elderly persons with a history of falls. PLoS One. 2013 Aug 5;8(8):e70566. doi: 10.1371/journal.pone.0070566. Print 2013.
- Derived from this study: PubMed 23150931Jeffrey BA, Hannan MT, Quinn EK, Zimmerman S, Barton BA, Rubin CT, Kiel DP. Self-reported adherence with the use of a device in a clinical trial as validated by electronic monitors: the VIBES study. BMC Med Res Methodol. 2012 Nov 14;12:171. doi: 10.1186/1471-2288-12-171.
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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.
Douglas P. Kiel, MD, MPH principal investigator
Institute for Aging Research, Hebrew SeniorLife
Marian T. Hannan, DSc, MPH principal investigator
Institute for Aging Research, Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low magnitude mechanical stimulation in people with Osteopenia, run by Hebrew SeniorLife at 1 site in United States.
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 5 inclusion and 7 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 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan) (time frame: 2 - 3 years). 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 NCT00396994, which also lists 6 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 20 Mar 2013.