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)

January 31, 2020 updated by: University Hospital, Rouen
  • 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hurst coefficient
Time Frame: Day 0
measured by the BMA
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hurst coefficient
Time Frame: Month 12
measured by the BMA
Month 12
bone texture parameters
Time Frame: Day 0
bone texture parameters measured by Trabecular Bone Score
Day 0
bone texture parameters
Time Frame: Month 12
bone texture parameters measured by Trabecular Bone Score
Month 12
Bone mineral density
Time Frame: Day 0
Bone mineral density measured by DXA scan
Day 0
Bone mineral density
Time Frame: Month12
Bone mineral density measured by DXA scan
Month12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/183/HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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