Clinical trial NCT00720122: Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Official title: Effects of Recombinant Human Insulin Like Growth Factor-1 (rhIGF-1) on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Disorder of Bone Density and Structure, Unspecified
Keywords: Bone density
Bone turnover markers
rhIGF-1
Bone structure
Anorexia nervosa
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 28
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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-

Primary outcomes:
measure: Change in Spine Bone Density (g/cm^2)
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MD
name: Madhusmita Misra, MD
role: PRINCIPAL_INVESTIGATOR
References: