Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study (FEROS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01556360
First received: March 1, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.


Condition
Genetic Hemochromatosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: Change from baseline in bone mineral density at three years ] [ Designated as safety issue: No ]
    Vertebral and hips Dual energy X-ray Absorptiometry (DXA)


Secondary Outcome Measures:
  • Predictive value of iron overload on Bone Mineral Density [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Number of vertebral fractures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of peripheral fractures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number and location of joint lesions detected by the examination (pain and swelling) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Determination of genetic polymorphism of BMP 2 and 4 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
  • serum
  • urine
  • DNA

Estimated Enrollment: 150
Study Start Date: July 2008
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Bone diseases have been recognized recently as complications of genetic hemochromatosis. Further studies are needed to describe the role of iron in bone injuries. The purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with genetic hemochromatosis diagnosed in western France hospitals

Criteria

Inclusion Criteria:

  • Patients between 18 and 80 years
  • C282 homozygosity

Exclusion Criteria:

  • corticosteroids during the last 3 months
  • following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.
  • following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate.
  • cancer or evolutionary hemopathy (including monoclonal gammopathy)
  • pregnancy at inclusion time
  • treated osteoporosis
  • patient in wich follow up seems hard
  • inclusion in another study incompatible with this one
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556360

Locations
France
Angers University Hospital
Angers, France, 49933
Brest University Hospital
Brest, France, 29609
Nantes University Hospital
Nantes, France, 44093
Orleans Regional Hospital
Orleans, France, 45100
Poitiers University Hospital
Poitiers, France, 86021
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Guggenbuhl Pascal, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01556360     History of Changes
Other Study ID Numbers: 2008-A000386-47
Study First Received: March 1, 2012
Last Updated: May 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
genetic hemochromatosis
Iron overload
C282 homozygosity

Additional relevant MeSH terms:
Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014