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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)

Primary Purpose

Low Bone Mass in Anorexia Nervosa Patients

Status
Unknown status
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
osteoanabolic therapy
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Bone Mass in Anorexia Nervosa Patients

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Zurich, Department of PsychiatryRecruiting
  • University Hospital Zurich, Rheumatology DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Teriparatide

Arm Description

one arm study. All patients receive teriparatide

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2013
Last Updated
March 25, 2014
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01801397
Brief Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

5. Study Description

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/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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Bone Mass in Anorexia Nervosa Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide
Arm Type
Other
Arm Description
one arm study. All patients receive teriparatide
Intervention Type
Drug
Intervention Name(s)
osteoanabolic therapy
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frey Diana, MD
Email
diana.frey@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriella Milos, MD
Email
gabriella.milos@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriella Milos, MD
Organizational Affiliation
University Hospital Zurich, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Department of Psychiatry
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
University Hospital Zurich, Rheumatology Department
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana P Frey, MD
Email
diana.frey@usz.ch
First Name & Middle Initial & Last Name & Degree
Diana P Frey, MD

12. IPD Sharing Statement

Learn more about this trial

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)

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