Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT00516386
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.
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Notify Me12 year–18 year
Female
Interventional
Phase 1 / Phase 2
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
35-40 mcg/k/dose twice daily SC
Other names: Increlex
Time frame: Baseline and 7-10 days
Time frame: Baseline and 7-10 days
Massachusetts General Hospital
Other
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