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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556360
First Posted: March 16, 2012
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
  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 ]
    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 ]
  • Number of vertebral fractures [ Time Frame: 3 years ]
  • Number of peripheral fractures [ Time Frame: 3 years ]
  • Number and location of joint lesions detected by the examination (pain and swelling) [ Time Frame: 3 years ]
  • Determination of genetic polymorphism of BMP 2 and 4 [ Time Frame: Baseline ]

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

Enrollment: 100
Study Start Date: July 2008
Primary Completion Date: August 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01556360     History of Changes
Other Study ID Numbers: 2008-A000386-47
First Submitted: March 1, 2012
First Posted: March 16, 2012
Last Update Posted: May 27, 2015
Last Verified: May 2015

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