Trial record 5 of 32 for:
hemochromatosis
Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study (FEROS)
This study is currently recruiting participants.
Verified June 2012 by Rennes University Hospital
Sponsor:
Rennes University Hospital
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01556360
First received: March 1, 2012
Last updated: June 29, 2012
Last verified: June 2012
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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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Number of vertebral fractures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Number of peripheral fractures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Number and location of joint lesions detected by the examination (pain and swelling) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Determination of genetic polymorphism of BMP 2 and 4 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
- serum
- urine
- DNA
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556360
Contacts
| Contact: Guggenbuhl Pascal, MD | 33-2-9926-7140 | pascal.guggenbuhl@chu-rennes.fr |
Locations
| France | |
| Angers University Hospital | Recruiting |
| Angers, France, 49933 | |
| Contact: Legrand Erick, MD, PhD 33-2-4135-7175 ErLegrand@chu-angers.fr | |
| Brest University Hospital | Recruiting |
| Brest, France, 29609 | |
| Contact: Saraux Alain, MD, PhD 33-2-9834-7264 alain.saraux@chu-brest.fr | |
| Nantes University Hospital | Recruiting |
| Nantes, France, 44093 | |
| Contact: Maugars Yves, MD, PhD 33-2-4008-4824 yves.maugars@chu-nantes.fr | |
| Orleans Regional Hospital | Recruiting |
| Orleans, France, 45100 | |
| Contact: Lespessailles Eric, MD 33-2-3851-4444 eric.lespessailles@chr-orleans.fr | |
| Poitiers University Hospital | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Debiais Françoise, MD, PhD 33-5-4944-4444 f.debiais@chu-poitiers.fr | |
| Rennes University Hospital | Recruiting |
| Rennes, France, 35033 | |
| Contact: Guggenbuhl Pascal, MD 33-2996-7140 pascla.guggenbuhl@chu-rennes.fr | |
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
| Principal Investigator: | Guggenbuhl Pascal, MD | Rennes University Hospital |
More Information
No publications provided
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01556360 History of Changes |
| Other Study ID Numbers: | 2008-A000386-47 |
| Study First Received: | March 1, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 |
ClinicalTrials.gov processed this record on May 22, 2013