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Completed

NCT Number: NCT01556360

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

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

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Key information

Conditions

Genetic Hemochromatosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemochromatosis Iron Metabolism Disorders Iron Overload Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Predictive value of iron overload on Bone Mineral Density

    Time frame: 1 day

  2. Number of vertebral fractures

    Time frame: 3 years

  3. Number of peripheral fractures

    Time frame: 3 years

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

    Time frame: 3 years

  5. Determination of genetic polymorphism of BMP 2 and 4

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: FEROS

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 16, 2012
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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