Status:
UNKNOWN
A Pilot Study to Evaluate the Effect of Forsteo (Teriparatide, 1-34-rh-PTH) in Anorexia Nervosa Patients With Low Bone Mineral Density and Increased Bone Fagility (FAN-Trial)
Lead Sponsor:
University of Zurich
Conditions:
Low Bone Mass in Anorexia Nervosa Patients
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
Study Title: A pilot study to evaluate the effect of Forsteo® (Teriparatide, 1-34 rh-PTH) in Anorexia Nervosa patients with low mineral density and increased bone fragility (FAN-Trial) Short Title/S...
Eligibility Criteria
Inclusion
- Inclusion criteria: •Women, aged \> 18 to \< 35 years
- Having severe anorexia nervosa (AN) (DSM-IV-R) for \> 12 months before screening
- Presenting with very low bone mineral density (defined as Z-Score \< -2.5 or T-Score \< -2.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) without any previous fragility fracture
- or low bone mineral density (defined as Z-Score \< -1.5 or T-Score \< -1.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral neck) and at least one previous fragility fracture
- In- and out-patients of the Centre for Eating Disorders at the Clinic for Psychiatry and Psychotherapy of the University Hospital of Zurich.
- Exclusion criteria: Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, osteomalacia, Paget's disease of bone), pre-existing hypercalcemia, severe renal impairment (GFR \< 30 ml/min), prior external beam or implant radiation therapy to the skeleton, skeletal malignancies or bone metastases, any unknown elevation of serum alkaline phosphatase, severe psychiatric diseases other than AN, drug addiction, HIV positive patients, pregnancy, open epiphyses
- •Incapacity to understand the aims of the study or patients not willing to collaborate.
Exclusion
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01801397
Start Date
March 1 2014
End Date
December 1 2016
Last Update
March 26 2014
Active Locations (2)
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1
University Hospital Zurich, Department of Psychiatry
Zurich, Canton of Zurich, Switzerland, 8091
2
University Hospital Zurich, Rheumatology Department
Zurich, Canton of Zurich, Switzerland, 8091