Disorder of Bone Density and Structure, UnspecifiedPhase 2814NCT00720122

Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa

A Phase 2 study testing Recombinant human insulin like growth factor-1 (rhIGF-1) in people with Disorder of Bone Density and Structure, Unspecified, run by Massachusetts General 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 12 to 26 years, women only
Conditions the study is for: Disorder of Bone Density and Structure, Unspecified
What is being tested?: Recombinant human insulin like growth factor-1 (rhIGF-1)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Oct 2011
Phase: Phase 2
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 12 to 26 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders

Who cannot join

Pregnant or nursing
Hematocrit < 30%, K < 3 mmol/L
Any illness (other than AN) known to affect bone and mineral metabolism such as diabetes, untreated hypo- or hyperthyroidism, or hyperparathyroidism
History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who are on estrogen will still be eligible to participate in the study because our data in adult women with AN do not indicate deleterious effects of estrogen in patients receiving rhIGF-

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Effects of Recombinant Human Insulin Like Growth Factor-1 (rhIGF-1) on Bone Metabolism in Adolescent Girls With Anorexia Nervosa

Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of insulin-like growth factor 1, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents and young adults with anorexia nervosa have not been studied. The goal of this proposal is to investigate the effects of recombinant human insulin-like growth factor 1 on bone density and bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a 6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients, being insulin-like growth factor 1 deficient, will respond to exogenously administered recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone turnover and an increase in bone density and improvement in bone structure, or maintain bone density (in contrast to the decrease in bone density expected in adolescent girls and women with anorexia nervosa who are not treated).

Conditions: Disorder of Bone Density and Structure, Unspecified
Being tested: Recombinant human insulin like growth factor-1 (rhIGF-1)
Keywords: Bone density, Bone turnover markers, rhIGF-1, Bone structure, Anorexia nervosa
Medical subject headings: Anorexia Nervosa

What participants receive

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

Recombinant human insulin like growth factor-1 (rhIGF-1)Drug
Also called Tercica
Twice daily

Study groups in NCT00720122
Study group	Role	What they receive
Anorexia Nervosa Females	Experimental	Not described Receives: Drug: Recombinant human insulin like growth factor-1 (rhIGF-1)

What is being measured

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

Change in Spine Bone Density (g/cm^2)
Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.
Measured: Baseline and 6 months

Timeline

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

Jul 2008Oct 2011

First posted22 Jul 2008 (estimated)
Study startJul 2008
Primary completionOct 2011
Study completionOct 2011

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.
Other trials for Disorder of Bone Density and Structure, UnspecifiedStudies of the same condition, open and under way.
More trials run by Massachusetts General 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00720122
Sponsor's protocol ID: MassGH
Other IDs: CDER
Acronym: 814
Status last verified: Oct 2021
First submitted: 18 Jul 2008
Last updated: 18 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Recombinant Human Insulin Like Growth Factor-1 (rhIGF-1) on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
ClinicalTrials.gov ID: NCT00720122
Acronym / sponsor ID: 814 / MassGH
Conditions: Disorder of Bone Density and Structure, Unspecified
Keywords: Bone density, Bone turnover markers, rhIGF-1, Bone structure, Anorexia nervosa
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Jul 2008
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 22 Jul 2008 (estimated)
Results: Posted 29 Feb 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Anorexia Nervosa Females	Experimental	Drug: Recombinant human insulin like growth factor-1 (rhIGF-1)

Who may qualify

Ages: 12 to 26 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders

Key exclusion criteria (4 listed)

Pregnant or nursing
Hematocrit < 30%, K < 3 mmol/L
Any illness (other than AN) known to affect bone and mineral metabolism such as diabetes, untreated hypo- or hyperthyroidism, or hyperparathyroidism
History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who are on estrogen will still be eligible to participate in the study because our data in adult women with AN do not indicate deleterious effects of estrogen in patients receiving rhIGF-

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
Recombinant human insulin like growth factor-1 (rhIGF-1)Also: TercicaTwice daily	Drug	Anorexia Nervosa Females

Primary outcome

Change in Spine Bone Density (g/cm^2)
Time frame: Baseline and 6 months
Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.

Results and safety

Results posted to the registry on 29 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anorexia Nervosa Females	28	19

Primary outcome: Change in Spine Bone Density (g/cm^2)

Time frame: Baseline and 6 months. Mean (Standard Error). Unit: gm/cm^2

Measure	Anorexia Nervosa Females n = 19
Value	-0.00558 (0.00653)

Anorexia Nervosa Females: Mean Difference (Final Values): -0.00558 (95% CI -0.0081 to 0.0193), p = 0.40, Paired t-test

Population analysed: The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol.

Adverse events

Time frame: For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anorexia Nervosa Females	5 of 28 (17.9%)	22 of 28 (78.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Madhusmita Misra, MD principal investigator

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

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 4 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 18 Nov 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2012). 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 in Spine Bone Density (g/cm^2) (time frame: Baseline and 6 months). 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 NCT00720122.

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 18 Nov 2021.