2025-522592-29-00招募中4 期
Effect of Romosozumab vs. Denosumab on Coronary Atherosclerotic Damage in Postmenopausal Osteoporotic Women: A Phase IV, Low-Risk, Pharmacological Intervention Study. ATRIO Study.
Ospedale Galeazzi S.p.A.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月23日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the coronary CT score adapted according to the CCTA-Leaman method after 12 months of therapy.
研究概览
简要总结
The primary objective of the study is to evaluate the impact of treatment with Romosozumab carried out according to the standard of care, compared to that with Denosumab, on the progression of coronary atherosclerotic damage in a cohort of female patients affected by post-menopausal osteoporosis, through the variation of the coronary CT score adapted according to the CCTA-Leaman method, after 12 months of therapy.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up visits
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients
- •Patients who need to initiate treatment with Romosozumab or Denosumab in accordance with the prescribing criteria for each drug as established by AIFA Note
- •patients on secondary prophylaxis
- •patients with postmenopausal osteoporosis (i.e., no menstruation for 12 months without an alternative medical cause. An elevated follicle-stimulating hormone level in the postmenopausal interval may be used to confirm a postmenopausal status in women not using hormonal contraceptives or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single elevated follicle-stimulating hormone measurement is insufficient)
- •Patients who sign the Informed Consent Form for participation in the study
排除标准
- •Diabetes mellitus
- •History of bone disease other than osteoporosis (e.g. Paget's disease)
- •Active neoplasms (including patients in remission for more than 5 years)
- •Previous acute myocardial infarction (AMI) and/or stroke, regardless of age of onset
- •Alcohol consumption (more than 2 units of alcohol/day)
- •Active smoking
- •Participation in a clinical study in which an investigational medicinal product was administered within 30 days prior to screening or within five half-lives of the study drug, whichever is longer
- •Patients with hypocalcemia, defined as plasma calcium corrected for albumin < 8.8 mg/dL.
- •Previous allergic reaction to iodinated contrast media or allergy or hypersensitivity to the study drugs (active substance and excipients)
- •Concomitant steroid or immunosuppressive therapy or other drugs known to interfere with bone metabolism
- •Women ≤ 69 years: cardiovascular risk ≥ 20% at 10 years according to the Heart Project risk charts
- •Women ≥ 70 years: 2OP score (ESC 2021) with risk > 15% at 10 years
- •Uncontrolled hypercholesterolemia without therapy or uncontrolled despite ongoing cholesterol-lowering therapy (LDL ≥ 116 mg/dl)
- •Uncontrolled hypertension without therapy or uncontrolled despite ongoing antihypertensive therapy (blood pressure ≥ 140/90 mmHg)
- •Active endocrinopathies (except subclinical hypothyroidism)
- •Chronic renal failure stages IIIb-IV-V (eGFR < 45 ml/min according to CKD-EPI)
- •Chronic liver disease (Child classifications B and C )
结局指标
主要结局
Change in the coronary CT score adapted according to the CCTA-Leaman method after 12 months of therapy.
Change in the coronary CT score adapted according to the CCTA-Leaman method after 12 months of therapy.
次要结局
- Change in scores: Segment Involvement Score (SIS) and Segment Stenosis Score (SSS) between V1 and V3
- Measurement of biomarkers at V1 and their correlation with changes in coronary scores: Sclerostin, Lipoprotein-Associated Phospholipase A2, Myeloid-Related Protein 8 and 14, and Monocyte Chemoattractant Protein 1 (MCP-1).
研究者
Dr. Antonio Rossi
Scientific
Ospedale Galeazzi S.p.A.
研究点 (2)
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