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

Osteoporosis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04253340
• Other study ID #: 2017/183/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hurst coefficient	measured by the BMA	Day 0
Secondary	Hurst coefficient	measured by the BMA	Month 12
Secondary	bone texture parameters	bone texture parameters measured by Trabecular Bone Score	Day 0
Secondary	bone texture parameters	bone texture parameters measured by Trabecular Bone Score	Month 12
Secondary	Bone mineral density	Bone mineral density measured by DXA scan	Day 0
Secondary	Bone mineral density	Bone mineral density measured by DXA scan	Month12