Effects of an Oral Contraceptive (Norgestimate/Ethinyl Estradiol) on Bone Mineral Density in Adolescent Females with Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study

To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS). Females 11–17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a...

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Published inJournal of adolescent health Vol. 39; no. 6; pp. 819 - 827
Main Authors Strokosch, Gary R., Friedman, Andrew J., Wu, Shu-Chen, Kamin, Marc
Format Journal Article
LanguageEnglish
Published New York, NY Elsevier Inc 01.12.2006
Elsevier Science
Subjects
Online AccessGet full text
ISSN1054-139X
1879-1972
1879-1972
DOI10.1016/j.jadohealth.2006.09.010

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Abstract To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS). Females 11–17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180–250 μg and ethinyl estradiol (EE) 35 μg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles. Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m 2; Placebo 17.6 kg/m 2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm 2 vs. .008 g/cm 2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm 2 vs. .019 g/cm 2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups. In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.
AbstractList To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS). Females 11-17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180-250 microg and ethinyl estradiol (EE) 35 microg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles. Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m2; Placebo 17.6 kg/m2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm2 vs. .008 g/cm2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups. In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.
To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS).PURPOSETo evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS).Females 11-17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180-250 microg and ethinyl estradiol (EE) 35 microg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles.METHODSFemales 11-17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180-250 microg and ethinyl estradiol (EE) 35 microg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles.Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m2; Placebo 17.6 kg/m2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm2 vs. .008 g/cm2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups.RESULTSDemographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m2; Placebo 17.6 kg/m2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm2 vs. .008 g/cm2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups.In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.CONCLUSIONSIn a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.
Purpose To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS). Methods Females 11-17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180-250 is a subset of g and ethinyl estradiol (EE) 35 is a subset of g or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles. Results Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m2; Placebo 17.6 kg/m2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm2 vs. .008 g/cm2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups. Conclusions In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.
To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS). Females 11–17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180–250 μg and ethinyl estradiol (EE) 35 μg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles. Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m 2; Placebo 17.6 kg/m 2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm 2 vs. .008 g/cm 2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm 2 vs. .019 g/cm 2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups. In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.
Purpose: To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS). Methods: Females 11-17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180-250 mg and ethinyl estradiol (EE) 35 mg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles. Results: Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m2; Placebo 17.6 kg/m2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm2 vs. .008 g/cm2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups. Conclusions: In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD. Tables, Figures. [Copyright 2006 The Society for Adolescent Medicine; published by Elsevier Inc.]
Author Kamin, Marc
Wu, Shu-Chen
Strokosch, Gary R.
Friedman, Andrew J.
Author_xml – sequence: 1
  givenname: Gary R.
  surname: Strokosch
  fullname: Strokosch, Gary R.
  organization: Eating Disorders Program, Department of Adolescent Medicine, Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois
– sequence: 2
  givenname: Andrew J.
  surname: Friedman
  fullname: Friedman, Andrew J.
  organization: Department of Internal Medicine, Johnson & Johnson Pharmaceutical Research & Development, Raritan, New Jersey
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  givenname: Shu-Chen
  surname: Wu
  fullname: Wu, Shu-Chen
  organization: Biostatistics Department, Scios Inc., Fremont, California
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  givenname: Marc
  surname: Kamin
  fullname: Kamin, Marc
  email: mkamin@obius.jnj.com
  organization: Ortho Biotech Clinical Affairs, L.L.C., Bridgewater, New Jersey
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1879-1972
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IsPeerReviewed true
IsScholarly true
Issue 6
Keywords Human
Ethinylestradiol
Estrogen
Norgestimate
Anorexia nervosa
Eating disorder
Ovarian hormone
Progestagen
Treatment
Adolescent
Placebo
Double blind study
Female
Contraceptive
Bone mineral density
Sex steroid hormone
Language English
License https://www.elsevier.com/tdm/userlicense/1.0
CC BY 4.0
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PublicationTitle Journal of adolescent health
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Elsevier Science
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Snippet To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not...
Purpose To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder...
Purpose: To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder...
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SubjectTerms Adolescent
Adolescent girls
Adult and adolescent clinical studies
Anorexia nervosa
Anorexia Nervosa - complications
Biological and medical sciences
Bone Density - drug effects
Bone mineral density
Contraceptives, Oral, Combined - pharmacology
Double-Blind Method
Eating behavior disorders
Ethinyl Estradiol-Norgestrel Combination - pharmacology
Feeding and Eating Disorders - etiology
Feeding and Eating Disorders - prevention & control
Female
Humans
Medical sciences
Oral contraceptives
Psychology. Psychoanalysis. Psychiatry
Psychopathology. Psychiatry
Title Effects of an Oral Contraceptive (Norgestimate/Ethinyl Estradiol) on Bone Mineral Density in Adolescent Females with Anorexia Nervosa: A Double-Blind, Placebo-Controlled Study
URI https://www.clinicalkey.com/#!/content/1-s2.0-S1054139X06003491
https://dx.doi.org/10.1016/j.jadohealth.2006.09.010
https://www.ncbi.nlm.nih.gov/pubmed/17116511
https://www.proquest.com/docview/20570670
https://www.proquest.com/docview/57199013
https://www.proquest.com/docview/68171431
Volume 39
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