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

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.

Study Overview

• Status: Completed
• Conditions: Genetic Hemochromatosis

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Angers University Hospital
  • Brest, France, 29609
    • Brest University Hospital
  • Nantes, France, 44093
    • Nantes University Hospital
  • Orleans, France, 45100
    • Orleans Regional Hospital
  • Poitiers, France, 86021
    • Poitiers university hospital
  • Rennes, France, 35033
    • Rennes university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with genetic hemochromatosis diagnosed in western France hospitals

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density	Vertebral and hips Dual energy X-ray Absorptiometry (DXA)	Change from baseline in bone mineral density at three years

Secondary Outcome Measures

Outcome Measure	Time Frame
Predictive value of iron overload on Bone Mineral Density	1 day
Number of vertebral fractures	3 years
Number of peripheral fractures	3 years
Number and location of joint lesions detected by the examination (pain and swelling)	3 years
Determination of genetic polymorphism of BMP 2 and 4	Baseline

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Guggenbuhl Pascal, MD, Rennes university hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (Estimate): March 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Iron overload; genetic hemochromatosis; C282 homozygosity
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Iron Metabolism Disorders; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Iron Overload; Hemochromatosis; Hemosiderosis
• Other Study ID Numbers: 2008-A000386-47