Evaluation of the optimum dose of growth hormone (GH) for restoring bone mass in adult-onset GH deficiency: results from two 12-month randomized studies

Summary objective To establish the optimum GH dose for restoring bone mineral density (BMD) in adult‐onset GH deficiency (GHDA). design Two separate randomized, controlled clinical trials. patients Fifty‐eight adults aged 45·1 (20–64) years with severe GHDA were followed in two 12‐month studies. In...

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Bibliographic Details
Published in:Clinical endocrinology (Oxford) 2002-08, Vol.57 (2), p.273-281
Main Authors: Abrahamsen, B., Hangaard, J., Horn, H. C., Hansen, T. B., Gregersen, G., Hansen-Nord, M., Vahl, N., Junker, P., Andersen, M., Hagen, C.
Format: Article
Language:English
Subjects:
Adenoma - blood
Adenoma - drug therapy
Adult
Alkaline Phosphatase - blood
Biological and medical sciences
Biomarkers - blood
Bone Density - drug effects
Bone Remodeling - drug effects
Collagen - blood
Collagen Type I
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Endocrinopathies
Female
Growth Hormone - administration & dosage
Growth Hormone - deficiency
Humans
Hypothalamus. Hypophysis. Epiphysis (diseases)
Male
Medical sciences
Middle Aged
Non tumoral diseases. Target tissue resistance. Benign neoplasms
Peptide Fragments - blood
Peptides - blood
Pituitary Neoplasms - blood
Pituitary Neoplasms - drug therapy
Procollagen - blood
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Summary:Summary objective To establish the optimum GH dose for restoring bone mineral density (BMD) in adult‐onset GH deficiency (GHDA). design Two separate randomized, controlled clinical trials. patients Fifty‐eight adults aged 45·1 (20–64) years with severe GHDA were followed in two 12‐month studies. In the first study, patients were randomized to placebo or GH 1·7 IU/m2/day and in the second study GH 0·5 IU/m2/day or 1·0 IU/m2/day. measurements BMD of the spine, hip, forearm and whole body was measured at 0 and 12 months. Alkaline phosphatase (AP) and collagen markers serum C‐terminal propeptide of type I collagen (PICP), type I collagen telopeptide (ICTP) and N‐terminal propeptide of type III collagen (PIIINP) were measured at baseline and every 3 months. results Biochemical markers of skeletal and soft tissue collagen increased significantly and remained elevated throughout the study period. BMD changes depended on site, dose and gender. In placebo‐treated patients, spinal BMD declined by 2·5%. At the low and medium doses, BMD increased by 2·4 and 3·1%, respectively, while a nonsignificant 0·2% decrease was seen with high dose. Forearm BMD decreased by 4·9% (P 
ISSN:0300-0664
1365-2265
DOI:10.1046/j.1365-2265.2002.01582.x