- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801397
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 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Frey Diana, MD
- Email: diana.frey@usz.ch
Study Contact Backup
- Name: Gabriella Milos, MD
- Email: gabriella.milos@usz.ch
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich, Department of Psychiatry
-
Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich, Rheumatology Department
-
Contact:
- Diana P Frey, MD
- Email: diana.frey@usz.ch
-
Sub-Investigator:
- Diana P Frey, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Teriparatide
one arm study.
All patients receive teriparatide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriella Milos, MD, University Hospital Zurich, Department of Psychiatry
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Psy-Rheu_2011/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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