Phase 3
N=77
Bone Loss in Women With Anorexia Nervosa
Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT00089843 ↗Enrolled (actual)
77
Serious AEs
18.2%
Results posted
Jun 2012
Primary outcome: Primary: Bone Mineral Density — 3.2; -0.6 percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testosterone (Drug); Actonel (risedronate) (Drug); Placebo Actonel (risedronate) (Drug); Placebo testosterone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density |
3.2; -0.6 | <0.0001 sig |
| SECONDARY Markers of Bone Metabolism |
-41; -11 | 0.002 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Anorexia Nervosa,
- Over 18,
- Female,
- Decreased bone density
Exclusion Criteria
- Medications to increase bone density
Data sourced from ClinicalTrials.gov (NCT00089843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.