Radiological Biological Genetic and Micro-architectural Bone Determinants of Fractures in Men With Low Bone Mineral Density

Plain-language summary

This study investigates the radiological, biological, genetic, and bone micro-architectural factors that contribute to fractures in men with low bone mineral density. It included men aged 40-70 with low bone density in at least one site. It was carried out as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Assistance Publique - Hôpitaux de Paris

Intervention

Radiology, Biological, biochemical and genetic samples

Start date

2/1/2008

Estimated completion

12/1/2010

Countries

France

Related genes

Locations

• Paris, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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