The effect of nandrolone decanoate on bone mineral density, muscle mass, and hemoglobin levels in elderly women with osteoporosis: a double-blind, randomized, placebo-controlled clinical trial.
METHODS
In a randomized, double-blind, placebo-controlled clinical trial, we evaluated the effect of a 2-year treatment with nandrolone decanoate (ND) on bone mineral density (BMD) of lumbar spine, femoral neck, and trochanter and on vertebral fracture rate, muscle mass, and hemoglobin levels. Sixty-five osteoporotic women older than 70 years were studied. Thirty-two patients received injections of 50 mg ND, and 33 received placebos every 3 weeks. All patients received 500 mg calcium tablets daily.


RESULTS
Compared to baseline, ND increased the BMD of the lumbar spine (3.4% +/- 6.0 and 3.7% +/- 7.4; p < .05) and femoral neck (4.1% +/- 7.3 and 4.7% +/- 8.0; p < .05) after 1 and 2 years, respectively. The BMD of trochanter increased significantly only after the first year (4.8% +/- 9.3, p < .05). Compared to the placebo group, the ND group presented with significantly increased BMD of the trochanter and neck. ND significantly reduced incidence of new vertebral fractures (21% vs 43% in the placebo group; p < .05). ND showed a significant statistical increase in lean body mass after the first (6.2% +/- 5.8; p < .01) and second years (11.9% +/- 29.2; p < .01). In addition, a 2-year treatment with ND significantly increased hemoglobin levels compared to baseline (14.3%; p < .01) and placebo (p < .01).


CONCLUSIONS
ND increased BMD, hemoglobin levels, and muscle mass, and reduced the vertebral fracture rate of elderly osteoporotic women.
Frisoli
Alberto
A
Gastric and Gerontology Division, Department of Medicine, Federal University of São Paulo, Brazil. frisoli@uol.com.br
Chaves
Paulo H M
PH
Pinheiro
Marcelo Medeiros
MM
Szejnfeld
Vera Lucia
VL
D015502:Absorptiometry, Photon; D000368:Aged; D000369:Aged, 80 and over; D000728:Androgens / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005598:Fractures, Spontaneous / Q000517:prevention & control; D006801:Humans; D009277:Nandrolone / Q000627:therapeutic use*; D015663:Osteoporosis, Postmenopausal / Q000175:diagnosis* / Q000188:drug therapy*; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000728:Androgens; D009277:Nandrolone