NCT04253340撤回不适用
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
University Hospital, Rouen0 个研究点目标入组 72 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 72
- 主要终点
- Hurst coefficient
研究概览
简要总结
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bone mineral analyser
Experimental
Diagnostic Test: Bone mineral analyser
high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12
干预措施: Bone mineral analyser (Diagnostic Test)
结局指标
主要结局
Hurst coefficient
时间窗: Day 0
measured by the BMA
次要结局
- Bone mineral density(Month12)
- Hurst coefficient(Month 12)
- bone texture parameters(Month 12)
- bone texture parameters(Day 0)
- Bone mineral density(Day 0)
研究者
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