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- Effects of physiologic growth hormone therapy on bone
density and body composition in patients with adult-onset growth hormone
deficiency. A randomized, placebo-controlled trial.
Baum HB, Biller BM, Finkelstein JS, Cannistraro KB, Oppenhein DS,
Schoenfeld DA, Michel TH, Wittink H, Klibanski A
Neuroendocrine Unit, Massachusetts General Hospital, Boston 02114, USA.
BACKGROUND: Patients with adult-onset growth hormone deficiency have reduced
bone density and increased fat mass. Growth hormone at high doses may
decrease body fat in these patients, but the effects of growth hormone at
more physiologic doses on bone density and body composition have not been
convincingly shown. OBJECTIVE: To determine whether long-term growth hormone
therapy at a dose adjusted to maintain normal insulin-like growth factor 1
(IGF-1) levels has clinical effects in patients with adult-onset growth
hormone deficiency. DESIGN: Randomized, placebo-controlled study. SETTING:
Tertiary referral center. PATIENTS: 32 men with adult-onset growth hormone
deficiency. INTERVENTION: Growth hormone (initial daily dose, 10
micrograms/kg of body weight) or placebo for 18 months. The growth hormone
dose was reduced by 25% if IGF-1 levels were elevated. MEASUREMENTS: Body
composition and bone mineral density of the lumbar spine, femoral neck, and
proximal radius were measured by dual energy x-ray absorptiometry at 6-month
intervals. Markers of bone turnover were also measured during the first 12
months of the study. RESULTS: Growth hormone therapy increased bone mineral
density in the lumbar spine by a mean (+/- SD) of 5.1% +/- 4.1% and bone
mineral density in the femoral neck by 2.4% +/- 3.5%. In the growth hormone
group, significant increases were seen in the following markers of bone
turnover: osteocalcin (4.4 +/- 3.6 mg/L to 7.2 +/- 4.6 mg/L) and urinary
pyridinoline (39.0 +/- 19.8 nmol/mmol of creatinine to 55.7 +/- 25.5 nmol/mmol
of creatinine) and deoxypyridinoline (8.4 +/- 7.1 nmol/mmol of creatinine to
14.9 +/- 9.4 nmol/mmol of creatinine). Percentage of body fat in the growth
hormone group decreased (from 31.9% +/- 6.5% to 28.3% +/- 7.0%), and lean
body mass increased (from 59.0 +/- 8.5 kg to 61.5 +/- 6.9 kg). These changes
were significant compared with corresponding changes in the placebo group (P
< 0.01 for all comparisons). CONCLUSIONS:
Growth hormone administered to men with adult-onset growth hormone
deficiency at a dose adjusted according to serum IGF-1 levels increases bone
density and stimulates bone turnover, decreases body fat and increases lean
mass, and is associated with a low incidence of side effects.
Publication Types:
- Clinical trial Randomized controlled trial
Comments:
- Comment in: Ann Intern Med 1996 Dec 1;125(11):932-4
PMID: 8967668, UI: 97067809
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