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)

Overview

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/Study ID:

FAN-Trial / Psy-Rheu_2011/1

Indication:

Low bone mineral density (Z-Score < -1.5 or T-Score < -1.5 if available) and fragility fractures or very low bone mineral density (Z-Score < -2.5 or T-Score <-2.5 if available) without fragility fractures in Anorexia Nervosa patients

Trial Design:

Open-label, single-centre pilot study with study drug treatment duration of 24 months.

Study Center:

Single-centre (University Hospital of Zürich)

Investigator(s)/Authors:

PD Dr. med Gabriella F. Milos (Principle Investigator and author), Dept of Psychiatry, Centre for Eating Disorders, University Hospital Zürich, CH-8091 Zürich Dr. med. Diana P. Frey (Co-Investigator and author), Dept. of Rheumatology, University Hospital Zürich, CH-8091 Zürich PD Dr. med. Daniel Uebelhart (author), SUVA Fribourg, CH-1701 Fribourg

Objective(s)/Outcome(s):

Primary endpoint:

•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.

Secondary endpoints:

- To assess the changes in blood biomarkers

- To assess changes in whole body composition

- To assess the incidence of new fragility fractures

- To assess changes in bone structure

- To assess the changes in EDE-Q

- Longterm safety and tolerability of Teriparatide (Forsteo®) in patients with AN

Assessments for primary endpoint:

•BMD at lumbar spine, total hip and femoral neck, measured by DXA

Assessments for secondary endpoints:

- bone resorption and bone formation markers measured in urine and serum

- whole body composition measured by DXA

- New clinical peripheral and vertebral fractures

- HRqCT of tibia and forearm

- EDE-Q Score at months 12 and 24

Safety measurements:

- Safety lab (blood and urine)

- Clinical adverse event monitoring at all visits Number of Subjects: 10

Diagnosis and Main 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.

Main 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.

Study Product, Dose, Route, Regimen:

Teriparatide (Forsteo®), 20µg s.c. daily for 24 months.

Duration of study:

24 months.

Reference therapy, Dose, Route, Regimen:

NA

- Trial with medicinal product

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Interventions

  • Drug: osteoanabolic therapy

Arms, Groups and Cohorts

  • Other: Teriparatide
    • one arm study. All patients receive teriparatide

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 24 months

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gabriella Milos, MD, Principal Investigator, University Hospital Zurich, Department of Psychiatry
  • Overall Contact(s)
    • Frey Diana, MD, diana.frey@usz.ch

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.