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

Not Applicable

• Conditions: Osteoporosis
• Interventions: Diagnostic Test: Bone mineral analyser

• Registration Number: NCT04253340
• Lead Sponsor: University Hospital, Rouen

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Study Start: 2020-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone mineral analyser	Bone mineral analyser	Diagnostic Test: Bone mineral analyser high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12

Primary Outcome Measures

Name	Time	Method
Hurst coefficient	Day 0	measured by the BMA

Secondary Outcome Measures

Name	Time	Method
Hurst coefficient	Month 12	measured by the BMA
bone texture parameters	Month 12	bone texture parameters measured by Trabecular Bone Score
Bone mineral density	Month12	Bone mineral density measured by DXA scan