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Clinical Trials/NCT04253340
NCT04253340
Withdrawn
Not 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

University Hospital, Rouen0 sites72 target enrollmentMarch 1, 2020
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ConditionsOsteoporosis
InterventionsBone mineral analyser

Overview

Phase
Not Applicable
Intervention
Bone mineral analyser
Conditions
Osteoporosis
Sponsor
University Hospital, Rouen
Enrollment
72
Primary Endpoint
Hurst coefficient
Status
Withdrawn
Last Updated
2 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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
Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
March 1, 2023
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Bone mineral analyser

Outcomes

Primary Outcomes

Hurst coefficient

Time Frame: Day 0

measured by the BMA

Secondary Outcomes

  • Bone mineral density(Month12)
  • Hurst coefficient(Month 12)
  • bone texture parameters(Month 12)
  • bone texture parameters(Day 0)
  • Bone mineral density(Day 0)

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