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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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04253340
Acronym
TEOBASO
Enrollment
0
Registered
2020-02-05
Start date
2020-03-01
Completion date
2023-03-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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

Interventions

DIAGNOSTIC_TESTBone mineral analyser

high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hurst coefficientDay 0measured by the BMA

Secondary

MeasureTime frameDescription
Hurst coefficientMonth 12measured by the BMA
bone texture parametersDay 0bone texture parameters measured by Trabecular Bone Score
Bone mineral densityDay 0Bone mineral density measured by DXA scan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026