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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)

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ClinicalTrials.gov Identifier: NCT04253340
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Osteoporosis Diagnostic Test: Bone mineral analyser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: 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

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 :
  1. Hurst coefficient [ Time Frame: Day 0 ]
    measured by the BMA


Secondary Outcome Measures :
  1. Hurst coefficient [ Time Frame: Month 12 ]
    measured by the BMA

  2. bone texture parameters [ Time Frame: Day 0 ]
    bone texture parameters measured by Trabecular Bone Score

  3. bone texture parameters [ Time Frame: Month 12 ]
    bone texture parameters measured by Trabecular Bone Score

  4. Bone mineral density [ Time Frame: Day 0 ]
    Bone mineral density measured by DXA scan

  5. Bone mineral density [ Time Frame: Month12 ]
    Bone mineral density measured by DXA scan



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04253340    
Other Study ID Numbers: 2017/183/HP
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases