Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improve⦠(NCT04253340) | Clinical Trial Compass
WithdrawnNot Applicable
Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improvement in Bone Status After an Infusion of Zoledronic Acid in Osteoporotic Women
Stopped: Non-functional BMA machine.
0Started 2020-03-01
Plain-language summary
* Collection of epidemiological data
* Biological assessment as part of routine care.
* Measurement of the Hurst coefficient at D0
* Measurement of bone density and TBS on D0
* Zoledronic acid infusion the month following inclusion
* phone call at 1 month (observance of zoledronic acid)
* Measurement of bone density, calculation of the Hurst coefficient at M12
Who can participate
Age range18 Years ā 85 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women \< 85 years old
* Postmenopausal women (amenorrhea for more than 12 months), a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).
* Post-menopausal osteoporosis with one or more severe fractures (upper end of the humerus, femur, or tibia; 3 adjacent ribs; lower end of the femur; thoracic or lumbar spine; pelvis), or T score \<-3 which justifies setting up a bisphosphonate treatment
* Affiliated to social security
Exclusion Criteria:
* Contraindication to zoledronic acid (allergy to the product, creatinine clearance \<35 ml / min, hypocalcemia, open and unhealed lesions of the soft tissues of the mouth)
* Hormone replacement therapy taken in the last 12 months
* Osteoprotective treatment (bisphosphonates, teriparatide, raloxifene, strontium ralenate or denosumab) taken in the last 12 months
* Secondary osteoporosis: hyperthyroidism, hyperparathyroidism, long-term corticosteroid therapy, hypercorticism, hypogonadism, treatment with anti aromatases / LHRH analogues, neoplastic pathology (solid or hemopathy)
* History of bilateral wrist or femur fracture
* Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
* Patient participating in another trial / having participated in another trial within 6 months