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

Short name 814

NCTNCT00720122Other idMassGHOther idCDER

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 28 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2008
Primary completion: Oct 2011
Completion: Oct 2011
First posted: 22 Jul 2008 (estimated)
Last update posted: 18 Nov 2021
Conditions: Disorder of Bone Density and Structure, Unspecified

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20082009201020112012

Ph 2
814
NCT00720122
Jul 2008 to Oct 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Recombinant human insulin like growth factor-1 (rhIGF-1)Drug

Arms1

Experimental
Anorexia Nervosa Females

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Spine Bone Density (g/cm^2)
Time frame · Baseline and 6 months
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 6 months

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

Group	Value (gm/cm^2)	Spread
Anorexia Nervosa Females	-0.00558	0.00653

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Anorexia Nervosa FemalesFemales aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously	–	5 / 28	22 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 12 Years up to 26 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: \- Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders Exclusion Criteria: * 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-

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