CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 77 enrolled
Drug / intervention
Testosterone +3 moredrug
Likely dose
Testosterone patch 150 mcg daily and/or risedronate 35 mg orally once weeklyAI-extracted
Key inclusion· 4
  • ✓Diagnosis of anorexia nervosa
  • ✓Age over 18 years
  • ✓Female sex
  • ✓Documented decreased bone density
Key exclusion· 1
  • ✕Current use of medications to increase bone density

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00089843
NCT00089843Phase 3Completed
CompareCT.gov

IGF-1 and Bone Loss in Women Anorexia Nervosa

Massachusetts General Hospital·interventional·Posted Aug 17, 2004·Updated Sep 2, 2020

In Brief

A Phase 3 clinical trial evaluating Testosterone, Actonel (risedronate), and 2 other interventions for Anorexia Nervosa. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnorexia Nervosa
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2004
Enrollment StartJun 1, 2003
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 21.9 years ago

Interventions

Testosteronedrug

Testosterone patch 150mcg daily

Actonel (risedronate)drug

Actonel (risedronate) 35mg PO one time weekly

Placebo Actonel (risedronate)drug

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

Placebo testosteronedrug

Placebo patch identical in appearance to testosterone patch