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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Diagnostic Test: Bone mineral analyser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone mineral analyser<br>Diagnostic Test: Bone mineral analyser high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12 | Diagnostic Test: Bone mineral analyser<br>* high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hurst coefficient | measured by the BMA | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hurst coefficient | measured by the BMA | Month 12 | 
| bone texture parameters | bone texture parameters measured by Trabecular Bone Score | Day 0 | 
| bone texture parameters | bone texture parameters measured by Trabecular Bone Score | Month 12 | 
| Bone mineral density | Bone mineral density measured by DXA scan | Day 0 | 
| Bone mineral density | Bone mineral density measured by DXA scan | Month12 |