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Phase 3
18 Years
35 Years
Not Enrolling
Female
Low Bone Mass in Anorexia Nervosa Patients

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Trial Information

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy of Teriparatide (Forsteo®) in increasing the bone mineral density in the lumbar spine, total hip and femoral neck in patients with anorexia nervosa and low bone density at months 12 and 24.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Gabriella Milos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Department of Psychiatry

Authority:

Switzerland: Swissmedic

Study ID:

Psy-Rheu_2011/1

NCT ID:

NCT01801397

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Low Bone Mass in Anorexia Nervosa Patients
  • Anorexia
  • Anorexia Nervosa

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