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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 (TEOBASO)

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bone mineral analyser
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bone mineral analyser

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Hurst coefficient
    measured by the BMA

    Secondary Outcome Measures

    Hurst coefficient
    measured by the BMA
    bone texture parameters
    bone texture parameters measured by Trabecular Bone Score
    bone texture parameters
    bone texture parameters measured by Trabecular Bone Score
    Bone mineral density
    Bone mineral density measured by DXA scan
    Bone mineral density
    Bone mineral density measured by DXA scan

    Full Information

    First Posted
    January 29, 2020
    Last Updated
    January 31, 2020
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04253340
    Brief Title
    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
    Acronym
    TEOBASO
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    March 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bone mineral analyser
    Arm Type
    Experimental
    Arm Description
    Diagnostic Test: Bone mineral analyser high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Bone mineral analyser
    Intervention Description
    high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12
    Primary Outcome Measure Information:
    Title
    Hurst coefficient
    Description
    measured by the BMA
    Time Frame
    Day 0
    Secondary Outcome Measure Information:
    Title
    Hurst coefficient
    Description
    measured by the BMA
    Time Frame
    Month 12
    Title
    bone texture parameters
    Description
    bone texture parameters measured by Trabecular Bone Score
    Time Frame
    Day 0
    Title
    bone texture parameters
    Description
    bone texture parameters measured by Trabecular Bone Score
    Time Frame
    Month 12
    Title
    Bone mineral density
    Description
    Bone mineral density measured by DXA scan
    Time Frame
    Day 0
    Title
    Bone mineral density
    Description
    Bone mineral density measured by DXA scan
    Time Frame
    Month12

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    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

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