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Effects of Anorexia Nervosa on Bone Mass in Adolescents

NCT ID: NCT00088153

Last Updated: 2021-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Adolescence is a critical time for bone mineral accretion as between 60-90% of peak bone mass is established during this period, and peak bone mass is a major determinant of bone density and osteoporosis risk during adulthood. Anorexia nervosa (AN) is the third most common chronic illness among adolescent girls, with a prevalence of 0.2-1.0%. Therefore, AN occurs at a time during which patients are the most vulnerable to disruption of bone mineral accretion. Osteopenia is a major co-morbid complication of AN in 50-75% of female adolescents and adult women with this eating disorder. Women with the onset of the disorder during adolescence have more severe osteopenia than women with onset during adulthood. Little is known about the pathogenesis of osteopenia in this adolescent population and there are no established therapies. Improved understanding of bone mineral metabolism and factors which predict recovery of bone mineral accretion are critical in the development of therapeutic strategies to preserve and maximize bone mass in girls with the onset of AN during adolescence. Estrogen is known to be a critical factor in the development of peak bone mass. Although AN is associated with profound estrogen deficiency, there are no controlled studies investigating the effects of estrogen administration in this population.

This research proposal will address critical unanswered questions regarding bone abnormalities in adolescents with anorexia nervosa. Defining changes in bone formation with weight recuperation and hormonal variables would provide insight into the factors essential for bone mineral accretion during adolescence, as well as those that predict recovery. Determination of dose-dependent estrogen effects in this population will be key in targeting interventions during the time of active disease, with the long-term goal of preserving peak bone mass accretion in this vulnerable group of patients. Data obtained from women with post-menopausal osteoporosis or from women with AN cannot be extrapolated to adolescent patients who are in an active period of bone growth and mineralization as well as remodeling. Given the increasing prevalence of AN and its profound consequences on bone health, these studies will provide much needed data to enable treatment strategies for this severe co-morbid disease.

Conditions

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Anorexia Nervosa

Keywords

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Anorexia Nervosa Amenorrhea Bone Mass Growth hormone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Physiologic estrogen replacement

Mature girls with anorexia nervosa (AN) (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).

Immature girls with AN (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study

Group Type EXPERIMENTAL

Physiologic Estrogen/progesterone

Intervention Type DRUG

Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month

Placebo

Placebo patches or pills

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month

Interventions

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Physiologic Estrogen/progesterone

Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month

Intervention Type DRUG

Placebo

Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month

Intervention Type OTHER

Other Intervention Names

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Bone age >=15: Vivelle Dot patch with cyclic Provera

Eligibility Criteria

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Inclusion Criteria

* Females Only with Anorexia Nervosa and Amenorrhea 12-18 years
* Normal-weight girls 12-18 years with no past or present history of an eating disorder

Exclusion Criteria

* Diseases affecting bone metabolism (including untreated thyroid disease, premature ovarian failure, diabetes, cancer, pituitary, renal disease or bone fracture within the past six months)
* Use of prescription medications affecting bone metabolism within three months
* Suicidality
* Psychosis
* Substance abuse
* Hematocrit \<30 %
* Potassium \<3.0 mmol/L
* Glucose \<50 mg/dl.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Madhusmita Misra

Chief, Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhusmita Misra, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21698665 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24021517 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22728230 (View on PubMed)

Other Identifiers

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R01DK062249

Identifier Type: NIH

Identifier Source: secondary_id

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DK062249

Identifier Type: -

Identifier Source: org_study_id