Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study
Overview
The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.
Full Title of Study: “Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: August 2014
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.
Clinical Trial Outcome Measures
Primary 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 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Rennes University Hospital
- Collaborator
- Ministry of Health, France
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Guggenbuhl Pascal, MD, Principal Investigator, Rennes University Hospital
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