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ARS Home » Plains Area » Houston, Texas » Children's Nutrition Research Center » Research » Publications at this Location » Publication #71097
Title: A RANDOMIZED CLINICAL TRIAL OF BONE MINERAL DENSITY CHANGES IN YOUNG WOMEN WITH HYPOTHALAMIC AMENORRHEA TREATED WITH ORAL CONTRACEPTIVE PILLS

Author
item HERGENROEDER, A - BAYLOR COLL OF MEDICINE
item Ellis, Kenneth
item KLISH, WILLIAM - BAYLOR COLL OF MEDICINE
item SMITH, OBRIAN - BAYLOR COLL OF MEDICINE

Submitted to: Pediatric Research
Publication Type: Proceedings
Publication Acceptance Date: 6/1/1996
Publication Date: N/A
Citation: N/A

Interpretive Summary:

Technical Abstract: Purpose: To assess the changes in whole body and regional bone mineral density (BMD, gm/cm2) associated with treatment with ethinyl estradiol/norethindrone (OCP) versus oral medroxyprogesterone or placebo therapy over 12 months in 14-28 year olds with hypothalamic amenorrhea (HA). Methods: Subjects were identified with amenorrhea for > 6 months, and dhistory, physical examination, and laboratory screening established the diagnosis of HA. BMD was measured at 0, 6, and 12 months. Subjects were randomized to receive ethinyl estradiol (0.035mg)/norethindrone (0.5-1.0) 21 days/28 days (OCP group) OR medroxyprogesterone 10 mg/d for 12 days per month OR placebo 12 days per month. For the purposes of this report, the medroxyprogesterone and placebo treatment groups were combined (non-OCP group) and compared with the OCP group using subjects who have completed 12 months of the study. Results: Over 12 months, spinal BMD increased 3.7% in the OCP group and decreased 2.9% in the non-OCP group (p=0.014). Change in spinal BMD was related to treatment with OCP (p=0.007) but was independent of calorie and calcium intake, energy balance, energy expenditure, and weight change. Conclusion: This is the first report of a beneficial effect of OCP on spine BMD over 12 months in young women with HA, compared to young women not treated with OCP, using a randomized, controlled clinical trial. Funded by NIH Grant M01RR-00188, General Clinical Research Center.