Phase 3
N=110
Effects of Anorexia Nervosa on Bone Mass in Adolescents
Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT00088153 ↗Enrolled (actual)
110
Serious AEs
25.5%
Results posted
Oct 2011
Primary outcome: Primary: Percent Change in Spine Bone Density Over the Study Duration (18 Months) — 2.6; 0.3 Percent change — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Physiologic Estrogen/progesterone (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Spine Bone Density Over the Study Duration (18 Months) |
2.6; 0.3 | <0.05 sig |
| PRIMARY Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months) |
-0.026; -0.236 | <0.05 sig |
| SECONDARY Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months) |
-2.9; -10.9 | >0.05 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00088153). 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.