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Bone Loss in Women With Anorexia Nervosa

NCT00089843 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-09-02

Study results available
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Summary

Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition.

Conditions

  • Anorexia Nervosa

Interventions

DRUG

Testosterone

Testosterone patch 150mcg daily

DRUG

Actonel (risedronate)

Actonel (risedronate) 35mg PO one time weekly

DRUG

Placebo Actonel (risedronate)

Placebo tablet identical in appearance to active Actonel (risedronate) tablet

DRUG

Placebo testosterone

Placebo patch identical in appearance to testosterone patch

Sponsors & Collaborators

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

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Anne Klibanski, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00089843 on ClinicalTrials.gov