Effects of Anorexia Nervosa on Bone Mass in Adolescents
Summary
This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in adolescents. Whether administration of estrogen, a normal hormone present during puberty, can help maintain bone development in girls with anorexia nervosa will be determined.
Timeline
- Start
- 2003-07
- Primary completion
- 2011-02
- Completion
- 2011-06
Outcome
Met primary endpoint
registry MEAN Physiologic Estrogen Replacement: 2.6 (Standard Deviation 1.0) Percent change MEAN Placebo: 0.3 (Standard Deviation 0.1) Percent change analysis (unspecified test); Physiologic Estrogen Replacement vs Placebo; p <0.05 NCT00088153 ↗
registry MEAN Physiologic Estrogen Replacement: -0.026 (Standard Deviation 0.078) Z -scores MEAN Placebo: -0.236 (Standard Deviation 0.091) Z -scores analysis (unspecified test); Physiologic Estrogen Replacement vs Placebo; p <0.05 NCT00088153 ↗
Publications
- Results Misra M, Katzman D, Miller KK, Mendes N, Snelgrove D, Russell M, Goldstein MA, Ebrahimi S, Clauss L, Weigel T, Mickley D, Schoenfeld DA, Herzog DB, Klibanski A. Physiologic estrogen replacement increases bone density in adolescent girls with anorexia nervosa. J Bone Miner Res. 2011 Oct;26(10):2430-8. doi: 10.1002/jbmr.447.
- Misra M, Katzman DK, Estella NM, Eddy KT, Weigel T, Goldstein MA, Miller KK, Klibanski A. Impact of physiologic estrogen replacement on anxiety symptoms, body shape perception, and eating attitudes in adolescent girls with anorexia nervosa: data from a randomized controlled trial. J Clin Psychiatry. 2013 Aug;74(8):e765-71. doi: 10.4088/JCP.13m08365.
- Faje AT, Fazeli PK, Katzman DK, Miller KK, Breggia A, Rosen CJ, Mendes N, Klibanski A, Misra M. Sclerostin levels and bone turnover markers in adolescents with anorexia nervosa and healthy adolescent girls. Bone. 2012 Sep;51(3):474-9. doi: 10.1016/j.bone.2012.06.006. Epub 2012 Jun 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 100 ug | Other |
| Subject | medroxyprogesterone acetate | Other / unclassified | 2.5 mg | — |