Study Stopped
Non-functional BMA machine.
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
TEOBASO
1 other identifier
interventional
N/A
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFebruary 10, 2026
February 1, 2026
3 years
January 29, 2020
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Hurst coefficient
measured by the BMA
Day 0
Secondary Outcomes (5)
Hurst coefficient
Month 12
bone texture parameters
Day 0
bone texture parameters
Month 12
Bone mineral density
Day 0
Bone mineral density
Month12
Study Arms (1)
Bone mineral analyser
EXPERIMENTALDiagnostic Test: Bone mineral analyser high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12
Interventions
high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12
Eligibility Criteria
You may qualify if:
- Women \< 85 years old
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2020
First Posted
February 5, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
February 10, 2026
Record last verified: 2026-02