NCT01556360

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

6.1 years

First QC Date

March 1, 2012

Last Update Submit

May 26, 2015

Conditions

Genetic Hemochromatosis

Keywords

genetic hemochromatosisIron overloadC282 homozygosity

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

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

    Change from baseline in bone mineral density at three years

Secondary Outcomes (5)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with genetic hemochromatosis diagnosed in western France hospitals

You may qualify if:

  • Patients between 18 and 80 years
  • C282 homozygosity

You may not qualify if:

  • corticosteroids during the last 3 months
  • following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.
  • cancer or evolutionary hemopathy (including monoclonal gammopathy)
  • treated osteoporosis
  • patient in wich follow up seems hard

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Angers University Hospital

Angers, 49933, France

Location

Brest University Hospital

Brest, 29609, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Orleans Regional Hospital

Orléans, 45100, France

Location

Poitiers University Hospital

Poitiers, 86021, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

* serum * urine * DNA

MeSH Terms

Conditions

HemochromatosisIron Overload

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Guggenbuhl Pascal, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 16, 2012

Study Start

July 1, 2008

Primary Completion

August 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

FR(6)