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

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01556360
Collaborator
Ministry of Health, France (Other)
100
Enrollment
6
Locations
16.7
Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.
    Study Start Date :
    Jul 1, 2008
    Actual Primary Completion Date :
    Aug 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Bone mineral density [Change from baseline in bone mineral density at three years]

      Vertebral and hips Dual energy X-ray Absorptiometry (DXA)

    Secondary Outcome Measures

    1. Predictive value of iron overload on Bone Mineral Density [1 day]

    2. Number of vertebral fractures [3 years]

    3. Number of peripheral fractures [3 years]

    4. Number and location of joint lesions detected by the examination (pain and swelling) [3 years]

    5. Determination of genetic polymorphism of BMP 2 and 4 [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Angers University Hospital Angers France 49933
    2 Brest University Hospital Brest France 29609
    3 Nantes University Hospital Nantes France 44093
    4 Orleans Regional Hospital Orleans France 45100
    5 Poitiers University Hospital Poitiers France 86021
    6 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01556360
    Other Study ID Numbers:
    • 2008-A000386-47
    First Posted:
    Mar 16, 2012
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Rennes University Hospital
    genetic hemochromatosis
    Iron overload
    C282 homozygosity
    Additional relevant MeSH terms:
    Hemochromatosis
    Hemosiderosis

    Study Results

    No Results Posted as of May 27, 2015