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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01801397
First received: February 26, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention Phase
Low Bone Mass in Anorexia Nervosa Patients
Drug: osteoanabolic therapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Teriparatide
one arm study. All patients receive teriparatide
Drug: osteoanabolic therapy

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801397

Contacts
Contact: Frey Diana, MD diana.frey@usz.ch
Contact: Gabriella Milos, MD gabriella.milos@usz.ch

Locations
Switzerland
University Hospital Zurich, Department of Psychiatry Recruiting
Zurich, ZH, Switzerland, 8091
University Hospital Zurich, Rheumatology Department Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Diana P Frey, MD       diana.frey@usz.ch   
Sub-Investigator: Diana P Frey, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Gabriella Milos, MD University Hospital Zurich, Department of Psychiatry
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01801397     History of Changes
Other Study ID Numbers: Psy-Rheu_2011/1
Study First Received: February 26, 2013
Last Updated: March 25, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014