Bone Mineral DensityNCT01010230

Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

A study testing LMHF mechanical stimulation active device in people with Bone Mineral Density and Bone Strength, run by St. Jude Children's Research Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Bone Mineral Density, Bone Strength
What is being tested?: LMHF mechanical stimulation active device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteUnited States
Study dates: May 2010to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Previously treated for childhood cancer at SJCRH
Greater than or equal to 5 years from childhood cancer diagnosis
Age and gender matched lumbar or whole body BMD z-score of <or equal -1.0
Not undergoing active treatment for cancer
≥ 7 and <18 years of age
Able to stand for 10 minutes (May hold on to a support while standing)
Able to tolerate Calcium and Vitamin D supplements

Who cannot join

Receiving pharmacologic interventions other than Calcium and Vitamin D supplements for reduced Bone Mineral density (e.g. bisphosphonates)
Pregnant female
Individuals with metal implants that prevent BMD analysis by Dual X-ray Absorptiometry (DXA) or Quantitative Computed Tomography (QTC)
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent.
Spinal deformity requiring bracing
Chronic oral glucocorticoid therapy
Diagnosis of hereditary retinoblastoma (bilateral disease, familial, or positive test), Li-Fraumeni syndrome (positive testing for p53 mutation), Gorlin syndrome/Basil Cell Nevus syndrome, Bloom syndrome, Fanconi anemia, Ataxia telangiectasia or xeroderma pigmentosa

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105

Other trials in United States

About this study

Treatment for childhood cancer interferes with normal bone maturation such that maximal peak bone mass may never be attained by some survivors of childhood cancer. In childhood cancer survivors, a randomized trial evaluating the effectiveness of vitamin D and calcium supplementation among ALL survivors is currently underway; however, few other interventions have been offered for this at risk population. Recent evidence demonstrates that low magnitude; high frequency mechanical stimulation can improve bone quantity and quality, perhaps providing an alternative or adjunct to pharmacologic intervention in populations where additional medications are either contraindicated or not acceptable to the individuals at risk. This application proposes a prospective double blind randomized clinical trial of low magnitude, high frequency mechanical (LMHF) stimulation for childhood cancer survivors whose bone mineral density is one or more standard deviations below the mean for their age and gender.

Read the detailed description

This study is a two arm parallel allocation of participants to either the intervention or control group will be utilized for a one year trial.

Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. Participants in the control arm will stand on a placebo device.

This study will evaluate the effects of low magnitude, high frequency stimulus on bone mineral content(BMC), bone mineral density (BMD), and bone strength in childhood cancer survivors who present with BMD values 1.0 or more standard deviations below the mean for their age and gender for the lumbar or whole body. This study will evaluate the effects of low magnitude, high frequency stimulus on markers of bone turnover in childhood cancer survivors who present with BMD values 1.0 or more standard deviations below the mean for their age and gender for the lumbar or whole body.

At baseline participants will have evaluations to determine bone mineral content and bone mineral density (Dual X-ray Absorptiometry and Qualitative Computed Tomography) and a blood sample collected to measure biomarkers of bone turnover, hormonal status and Vitamin D metabolism. Anthropometrics and tanner stage will be obtained at baseline, 3 months, 6 months, 9 and 12 months. A physical activity monitor will be worn for a 7 day period and a food frequency questionnaire will be completed. Tibial length will be measured. Participants have a blood sample collected either at home or at St. Jude Children's Research Hospital (SJCRH) every 3 months during the study to measure biomarkers of bone turnover, hormonal status and Vitamin D metabolism, anthropometrics and tanner stage, physical activity monitor and food frequency questionnaire. All measurements and evaluations required at baseline will be repeated at the completion of study visit.

Conditions: Bone Mineral Density, Bone Strength
Being tested: LMHF mechanical stimulation active device, LMHF mechanical stimulation placebo device
Keywords: Childhood cancer survivors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LMHF mechanical stimulation active deviceDevice
Also called Bone mineral density
Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention.
LMHF mechanical stimulation placebo deviceDevice
Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention.

Study groups in NCT01010230
Study group	Role	What they receive
LMHF mechanical stimulation placebo device	Placebo comparator	The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration. Receives: Device: LMHF mechanical stimulation placebo device
LMHF mechanical stimulation	Active comparator	Low magnitude, high frequency mechanical stimulation device ("vibrating") platform Receives: Device: LMHF mechanical stimulation active device

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Measured: Baseline and 12 months after start of intervention
Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Measured: Baseline and 12 months after start of intervention/
Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Measured: Baseline and 12 months after the intervention begins
Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Measured: Baseline and 12 months after the intervention begins
Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Measured: Baseline and 12 months after the intervention begins
Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Measured: Baseline and 12 months after the intervention begins
Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Measured: Baseline and 12 months after the intervention begins

Secondary outcomes (6)

Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Measured: Baseline and 12 months after the intervention begins
Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Measured: Baseline and 12 months after the intervention begins
Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Measured: Baseline and 12 months after the intervention begins
Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Measured: Baseline and 12 months after the intervention begins
Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent.
Measured: Baseline and 12 months after the intervention begins
Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups
Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index.
Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis.
Measured: Baseline and 12 months after the intervention begins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Mar 2013

First posted9 Nov 2009 (estimated)
Study startMay 2010
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bone Mineral DensityStudies of the same condition, open and under way.
More trials run by St. Jude Children's Research HospitalThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01010230
Sponsor's protocol ID: VIBE
Other IDs: R21HD059292, Gabrielle's Angel Fdn
Status last verified: Apr 2014
First submitted: 6 Nov 2009
Last updated: 4 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mogil RJ, Kaste SC, Ferry RJ Jr, Hudson MM, Mulrooney DA, Howell CR, Partin RE, Srivastava DK, Robison LL, Ness KK. Effect of Low-Magnitude, High-Frequency Mechanical Stimulation on BMD Among Young Childhood Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. 2016 Jul 1;2(7):908-14. doi: 10.1001/jamaoncol.2015.6557.
PubMed 26967465

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors
ClinicalTrials.gov ID: NCT01010230
Acronym / sponsor ID: VIBE
Conditions: Bone Mineral Density, Bone Strength
Keywords: Childhood cancer survivors
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: St. Jude Children's Research HospitalUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gabrielle's Angel Foundation
Study start: May 2010
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 9 Nov 2009 (estimated)
Results: Posted 26 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is a two arm parallel allocation of participants to either the intervention or control group will be utilized for a one year trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LMHF mechanical stimulation placebo device	Placebo comparator	Device: LMHF mechanical stimulation placebo deviceThe placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.
LMHF mechanical stimulation	Active comparator	Device: LMHF mechanical stimulation active deviceLow magnitude, high frequency mechanical stimulation device ("vibrating") platform

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Previously treated for childhood cancer at SJCRH
Greater than or equal to 5 years from childhood cancer diagnosis
Age and gender matched lumbar or whole body BMD z-score of <or equal -1.0
Not undergoing active treatment for cancer
≥ 7 and <18 years of age

Key exclusion criteria (7 listed)

Receiving pharmacologic interventions other than Calcium and Vitamin D supplements for reduced Bone Mineral density (e.g. bisphosphonates)
Pregnant female
Individuals with metal implants that prevent BMD analysis by Dual X-ray Absorptiometry (DXA) or Quantitative Computed Tomography (QTC)
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent.
Spinal deformity requiring bracing

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
LMHF mechanical stimulation active deviceAlso: Bone mineral densityParticipants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention.	Device	LMHF mechanical stimulation
LMHF mechanical stimulation placebo deviceParticipants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention.	Device	LMHF mechanical stimulation placebo device

Primary outcome

Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups
Time frame: Baseline and 12 months after start of intervention
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups
Time frame: Baseline and 12 months after start of intervention/
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.

6 secondary outcomes

Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins
Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups
Time frame: Baseline and 12 months after the intervention begins

Results and safety

Results posted to the registry on 26 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LMHF Mechanical Stimulation	32	22
Placebo Device	33	26

Primary outcome: Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups

Time frame: Baseline and 12 months after start of intervention. Mean (Standard Deviation). Unit: % change in grams/cm

Measure	LMHF Mechanical Stimulation n = 22	Placebo Device n = 26
Value	2.72 (10.41)	3.96 (11.31)

LMHF Mechanical Stimulation vs Placebo Device: Mean Difference (Final Values): -1.24 (95% CI -5.59 to 3.11), p = 0.69, ANOVA

Population analysed: This was an intent to treat analysis.

Primary outcome: Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups

Time frame: Baseline and 12 months after start of intervention/. Mean (Standard Deviation). Unit: % change in grams/cm

Measure	LMHF Mechanical Stimulation n = 22	Placebo Device n = 26
Value	3.70 (21.15)	2.54 (21.09)

LMHF Mechanical Stimulation vs Placebo Device: Mean Difference (Final Values): 1.16 (95% CI -6.93 to 9.25), p = 0.85, ANOVA

Population analysed: This was an intent to treat analysis.

Primary outcome: Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups

Time frame: Baseline and 12 months after the intervention begins. Mean (Standard Deviation). Unit: % change in g/cm^2

Measure	LMHF Mechanical Stimulation n = 22	Placebo Device n = 26
Value	7.08 (10.20)	4.88 (6.90)

LMHF Mechanical Stimulation vs Placebo Device: Mean Difference (Final Values): 3.19 (95% CI 0.43 to 5.95), p = 0.12, ANOVA

Population analysed: This was an intent to treat analysis.

Primary outcome: Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups

Time frame: Baseline and 12 months after the intervention begins. Mean (Standard Deviation). Unit: % change in g/cm^2

Measure	LMHF Mechanical Stimulation n = 22	Placebo Device n = 26
Value	4.91 (10.34)	5.01 (10.29)

LMHF Mechanical Stimulation vs Placebo Device: Mean Difference (Final Values): -0.10 (95% CI -4.24 to 4.05), p = 0.97, ANOVA

Population analysed: This was an intent to treat analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the on-study date until 12 months after the start of intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LMHF Mechanical Stimulation	0 of 22 (0%)	0 of 22 (0%)	Not reported
Placebo Device	1 of 26 (3.8%)	0 of 26 (0%)	Not reported

Limitations and caveats (from the sponsor): Dropout was higher than expected leading to small numbers for analysis. It was estimated that 30 persons were needed in each arm to detect a 5.5% difference in change in bone outcomes between the active device and placebo device arms of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26967465Mogil RJ, Kaste SC, Ferry RJ Jr, Hudson MM, Mulrooney DA, Howell CR, Partin RE, Srivastava DK, Robison LL, Ness KK. Effect of Low-Magnitude, High-Frequency Mechanical Stimulation on BMD Among Young Childhood Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. 2016 Jul 1;2(7):908-14. doi: 10.1001/jamaoncol.2015.6557.
St. Jude Children's Research HospitalLink provided by the sponsor.

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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.

Kirsten K Ness, PT, Ph.D principal investigator

St. Jude Children's Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LMHF mechanical stimulation active device in people with Bone Mineral Density and Bone Strength, run by St. Jude Children's Research Hospital 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 7 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 4 Jun 2014. 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?

Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups (time frame: Baseline and 12 months after start of intervention). The study lists 7 primary outcomes in all. 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 NCT01010230, which also lists 1 linked publication.

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 4 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.