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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)

U

University Hospital, Rouen

Status

Unknown

Conditions

Osteoporosis

Treatments

Diagnostic Test: Bone mineral analyser

Study type

Interventional

Funder types

Other

Identifiers

NCT04253340
2017/183/HP

Details and patient eligibility

About

  • 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

Enrollment

72 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

72 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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