Effects of transdermal estrogen on Bone Mass in adolescent female patients with Anorexia nervosa (AN) – a placebo-controlled, double-blind, randomized, interventional study.

Phase 2

Not yet recruiting

• Conditions: F50.0; Anorexia nervosa

• Registration Number: DRKS00014360
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• DSM 5 (307.1) for Anorexia nervosa
• Amenorrhea for a minimum of 3 months preceding study participation
• Age 14-20 years
• Bone age = 14 years
• BMI-Percentile = 5%

Exclusion Criteria

• Primary amenorrhea
• Premature ovarian failure, as demonstrated by an elevated FSH
• Diseases known to affect bone metabolism including:
-untreated thyreoid disease
-cushing syndrome
-diabetes
-pituitary disease
-renal failure
-prior bone fracture within 6 months of the study

• Medication known to affect bone metabolism (including gonadal steroids within the last 3 months)
• Evidence of:
-Suicidality
-Psychosis
-Substance abuse
• Abnormal TSH
• Hematocrit < 30%
Potassium < 3,0 mmol/l
Glucose < 50 mg/dl
• Pregnancy/lactation
• History of malignancy
• Contraindications to estrogen therapy (for girls with AN)
• Smoking

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is to determine the effect of continuously transdermal applicated 100µg 17-ß-estradiol with cyclic 10mg dydrogesterone orally given on Bone Mineral Density (BMD) veryfied by dual energy x-ray absorptiometry (DXA). A significant change in BMD z-scores in spine L1-L4 is expected in the experimental group.

Secondary Outcome Measures

Name	Time	Method
Significant change in BMD z-score in hip in experimental group