Status:
COMPLETED
Radiological Biological Genetic and Micro-architectural Bone Determinants of Fractures in Men With Low Bone Mineral Density
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Osteoporosis
Eligibility:
MALE
40-70 years
Phase:
NA
Brief Summary
Rational: Osteoporosis in men is responsible for one third of fragility fractures. However the definition and especially the determinants of fracture in humans are less well known than in women. Prim...
Detailed Description
Statistical Analysis: Relationship between computed scan parameters at different sites, bone micro-architectural parameters (peripheral scan), biological parameters, genetic markers and the occurrence...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject of masculine gender
- Aged ≥ 40 years and ≤ 70 years
- Subject with Z-score \< -2 at least one of 3 sites
- one of 3 sites (wrists, lumbar spine (defined on at least 2 continuous evaluable vertebrae between L1-L4) and femoral neck) discovered incidentally or not
- Subject who have signed the informed consent form
- The inclusion densitometry examination, less than 6 months old, will be performed on a Lunar or Hologic system. The reference data are the French reference data included in the Lunar system and TK in the Hologic system).
- Exclusion criteria:
- Patient or control subject with no affiliation at health national system (beneficiary or co-beneficiary)
- Subject who received any corticoid treatment more than 3 months along
- Subject with any known seropositivity for HIV
- Subject with a chronic inflammation disease (rheumatoid polyarthritis, ankylosing spondylarthritis, inflammatory bowel)
- Subject with secondary osteoporosis documented by clinical and biological examinations (serum calcium, serum phosphate, serum phosphatase alkaline, gamma GT, testosterone) in order to eliminate any chronic alcoholism, alcoholic cirrhosis, hypogonadism, osteomalacia, hemochromatosis, hyperthyroidism, primitive hyperparathyroidism, hypercorticism
- Subject who received treatment with bisphosphonates intravenously
- Subject who received a treatment with bisphosphonates (Actonel® or Fosamax®) for at least 5 years and stopped since less than 2 years
- Subject who received a treatment with bisphosphonates for at least 3 years and stopped since less than 1 year
- Subject who received a treatment with bisphosphonates during the 6 months before inclusion
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01250314
Start Date
February 1 2008
End Date
December 1 2010
Last Update
July 3 2012
Active Locations (1)
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1
Fédération de Rhumatologie - Hôpital LARIBOISIERE
Paris, France, 75010