Anorexia NervosaNCT01100567
Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa
A study testing Low-magnitude mechanical stimulation platform in people with Anorexia Nervosa, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. Read more about this study
- Who is it for?
- Ages 11 to 25 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Low-magnitude mechanical stimulation platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2015
- 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 11 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 11-25 years
- Diagnosis of anorexia nervosa based on DSM-IV criteria
- Female gender
- English-speaking
Who cannot join
- • Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus
- Use of medications known to affect bone metabolism in the last 3 months, such as:
- Glucocorticoid therapy (including inhaled steroids)
- Anticonvulsants
- Combined estrogen/progestin contraceptive agents (oral contraceptive pills)
- Depot medroxyprogesterone (Depo-Provera) use in the last 12 months
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. The primary focus of the trial is to conduct a prospective short-term intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and to determine the long-term effects of a biomechanical intervention on skeletal health in ambulatory adolescents with AN.
- Conditions
- Anorexia Nervosa
- Being tested
- Low-magnitude mechanical stimulation platform
- Keywords
- skeletal health, bone turnover, bone geometry, malnutrition
- Medical subject headings
- Anorexia Nervosa, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-magnitude mechanical stimulation platformDevice
Low-magnitude mechanical stimulation platform
| Study group | Role | What they receive |
|---|---|---|
| Placebo platform | Placebo comparator | Randomized to stand on placebo platform for 10 minutes/day Receives: Device: Low-magnitude mechanical stimulation platform |
| Low-magnitude mechanical stimulation | Active comparator | Randomized to stand on LMMS platform 10 minutes/daily Receives: Device: Low-magnitude mechanical stimulation platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in C-telopeptides
Measured: Baseline to 5 days
Secondary outcomes (1)
Change From Baseline in Bone Specific Alkaline Phosphatase
Measured: baseline to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startApr 2009
- Primary completionMay 2015
- Study completionMay 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Boston Children's 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Amy DiVasta, Boston Children's Hospital
- Investigators
- Amy D DiVasta, MD, MMSc, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100567
- Sponsor's protocol ID
- 08-10-0461
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2010
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
DiVasta AD, Stamoulis C, Rubin CT, Gallagher JS, Kiel DP, Snyder BD, Gordon CM. Low-Magnitude Mechanical Signals to Preserve Skeletal Health in Female Adolescents With Anorexia Nervosa: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2441779. doi: 10.1001/jamanetworkopen.2024.41779.
PubMed 39480424Lin JA, Stamoulis C, DiVasta AD. Associations between nutritional intake, stress and hunger biomarkers, and anxiety and depression during the treatment of anorexia nervosa in adolescents and young adults. Eat Behav. 2023 Dec;51:101822. doi: 10.1016/j.eatbeh.2023.101822. Epub 2023 Oct 26.
PubMed 38504970
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
- ClinicalTrials.gov ID
- NCT01100567
- Acronym / sponsor ID
- 08-10-0461
- Conditions
- Anorexia Nervosa
- Keywords
- skeletal health, bone turnover, bone geometry, malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. The primary focus of the trial is to conduct a prospective short-term intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and to determine the long-term effects of a biomechanical intervention on skeletal health in ambulatory adolescents with AN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo platform | Placebo comparator | Device: Low-magnitude mechanical stimulation platformRandomized to stand on placebo platform for 10 minutes/day |
| Low-magnitude mechanical stimulation | Active comparator | Device: Low-magnitude mechanical stimulation platformRandomized to stand on LMMS platform 10 minutes/daily |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 11-25 years
- Diagnosis of anorexia nervosa based on DSM-IV criteria
- Female gender
- English-speaking
Key exclusion criteria (7 listed)
- • Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus
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 stimulation platformLow-magnitude mechanical stimulation platform | Device | Low-magnitude mechanical stimulation, Placebo platform |
Primary outcome
Change From Baseline in C-telopeptides
Time frame: Baseline to 5 days
1 secondary outcome
Change From Baseline in Bone Specific Alkaline Phosphatase
Time frame: baseline to 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39480424DiVasta AD, Stamoulis C, Rubin CT, Gallagher JS, Kiel DP, Snyder BD, Gordon CM. Low-Magnitude Mechanical Signals to Preserve Skeletal Health in Female Adolescents With Anorexia Nervosa: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2441779. doi: 10.1001/jamanetworkopen.2024.41779.
- Derived from this study: PubMed 38504970Lin JA, Stamoulis C, DiVasta AD. Associations between nutritional intake, stress and hunger biomarkers, and anxiety and depression during the treatment of anorexia nervosa in adolescents and young adults. Eat Behav. 2023 Dec;51:101822. doi: 10.1016/j.eatbeh.2023.101822. Epub 2023 Oct 26.
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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.
Amy D DiVasta, MD, MMSc principal investigator
Boston Children's 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 Low-magnitude mechanical stimulation platform in people with Anorexia Nervosa, run by Boston Children's 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 4 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 17 May 2017. 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 17 May 2017). 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?
Change From Baseline in C-telopeptides (time frame: Baseline to 5 days). 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 NCT01100567, which also lists 2 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 17 May 2017.