Clinical trial NCT00516386: Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Official title: Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anorexia Nervosa
Keywords: Adolescents
Anorexia nervosa (AN)
Bone formation markers
Insulin like growth factor-1 (IGF-I)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Tercica
First posted: 2007-08-15
Enrollment: 16
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

Detailed description: Adolescents 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 I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied. The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN.

Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over 10 days with concomitant measurement of indices of bone turnover, and calcium regulatory hormones.

Eligibility criteria: Inclusion Criteria:

* Adolescent girls with anorexia nervosa 12-18 years old

Exclusion Criteria:

* Pregnancy or nursing
* Hematocrit \< 30%, K \< 3 mmol/L
* Any illness (other than anorexia nervosa) known to affect bone and mineral metabolism such as diabetes, alcoholism, untreated hypo- or hyperthyroidism, or hyperparathyroidism
* History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who were on estrogen were still eligible to participate in the study.

Primary outcomes:
measure: Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa
timeFrame: Baseline and 7-10 days
Secondary outcomes:
measure: Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa
timeFrame: Baseline and 7-10 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Madhu Misra
role: PRINCIPAL_INVESTIGATOR
References:
citation: Misra M, McGrane J, Miller KK, Goldstein MA, Ebrahimi S, Weigel T, Klibanski A. Effects of rhIGF-1 administration on surrogate markers of bone turnover in adolescents with anorexia nervosa. Bone. 2009 Sep;45(3):493-8. doi: 10.1016/j.bone.2009.06.002. Epub 2009 Jun 10.