Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in women with hypothalamic amenorrhea and osteopenia: an open-label extension of a double-blind, placebo-controlled study.
OBJECTIVE
The effects of long-term triphasic oral contraceptive administration on bone mineral density (BMD) were investigated in premenopausal women with hypothalamic amenorrhea (HA) and osteopenia.


METHODS
After completing three 28-day cycles in the double-blind phase of a placebo-controlled trial, women (mean age, 26.7 years) who received norgestimate 180-250 microg/ethinyl estradiol 35 microg (NGM/EE, n = 15) or placebo (n = 12) in the double-blind phase were to receive open-label NGM/EE for 10 additional cycles.


RESULTS
For subjects completing > or =10 NGM/EE treatment cycles, mean posteroanterior total lumbar spine BMD (L1-L4) increased from 0.881+/-0.0624 g/cm2 at baseline (last visit prior to NGM/EE) to 0.894+/-0.0654 g/cm2 at final visit (p = .043); no significant changes in hip BMD occurred. Decreases in N-telopeptide, osteocalcin, procollagen type I propeptide and bone-specific alkaline phosphatase levels indicated effects on bone metabolism.


CONCLUSIONS
Long-term administration of triphasic NGM/EE to osteopenic women with HA may increase total lumbar spine BMD.
Warren
Michelle P
MP
Columbia University, College of Physicians and Surgeons, Department of Obstetrics and Gynecology, PH 16-128, New York, NY 10032, USA. mpw1@columbia.edu
Miller
K K
KK
Olson
W H
WH
Grinspoon
S K
SK
Friedman
A J
AJ
D015502:Absorptiometry, Photon; D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000150:complications; D015415:Biomarkers / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects*; D001851:Bone Diseases, Metabolic / Q000150:complications / Q000378:metabolism; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage / Q000494:pharmacology*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007027:Hypothalamic Diseases / Q000150:complications; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging; D009644:Norgestrel / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology
D015415:Biomarkers; D003280:Contraceptives, Oral, Synthetic; D009644:Norgestrel; D004997:Ethinyl Estradiol; C017576:norgestimate