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Radiological Biological Genetic and Micro-architectural Bone Determinants of Fractures in Men With Low Bone Mineral Density
Bu çalışma, düşük kemik mineral yoğunluğu (low bone mineral density) olan erkeklerde kemik kırıklarına yol açan radyolojik, biyolojik, genetik ve kemik mikro-yapısına ait belirleyicileri araştırmaktadır. Çalışmaya, 40-70 yaş arası, en az bir bölgede düşük kemik yoğunluğu saptanan erkekler dahil edilmiştir. Faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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