ATRIO Study: Effect of Romosozumab vs. Denosumab on Coronary Atherosclerotic Damage in Postmenopausal Osteoporosis: A Phase IV, Low-Risk Intervention Study.

Trial details

Who runs it

Ospedale Galeazzi S.p.A.

Trial code

EU 2025-522592-29-00

Record updated

2026. augusztus 7.

Original description

The primary objective of the study is to evaluate the impact of treatment with romosozumab and denosumab on the progression of coronary atherosclerotic burden in a cohort of postmenopausal women with osteoporosis, through the change in coronary computed tomography angiography (CCTA) status, assessed using the Leaman score, after 12 months of therapyRead full original descriptionShow less

Effect of Romosozumab vs. Denosumab on Coronary Atherosclerotic Damage in Postmenopausal Osteoporotic Women: A Phase IV, Low-Risk, Pharmacological Intervention Study. ATRIO Study.

The primary objective of the study is to evaluate the impact of treatment with romosozumab and denosumab on the progression of coronary atherosclerotic burden in a cohort of postmenopausal women with osteoporosis, through the change in coronary computed tomography angiography (CCTA) status, assessed using the Leaman score, after 12 months of therapy

Inclusion: Postmenopausal women with osteoporosis (defined as the absence of menstruation for at least 12 consecutive months without an alternative medical cause. An elevated follicle-stimulating hormone [FSH] level within the postmenopausal range may be used to confirm postmenopausal status in women not using hormonal contraceptives or hormone replacement therapy; however, in the absence of 12 months of amenorrhea, a single elevated FSH measurement is insufficient for diagnosis); Patients requiring initiation of anti-osteoporotic therapy for secondary fracture prevention; Patients eligible for randomization to either treatment group according to AIFA note 79 as follows: Spine or femur T-score <-2.5 (<-2.0 if patient with ‚≥2 moderate or severe vertebral fractures or if femoral fracture in the previous 2 years) AND history of ‚≥1 moderate or severe vertebral fracture or ‚≥2 mild vertebral fractures or femoral fracture or at least 2 non-vertebral fractures AND high 10-year fracture risk (determined with a validated calculator) ‚≥20% AND inability to follow other effective treatments (intolerance, ineffectiveness, or expiration of the authorized use period); Patients who provide written informed consent to participate in the study.

Exclusion: Previous acute myocardial infarction (AMI) and/or stroke, regardless of age of onset; 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; 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; Diabetes mellitus; History of bone disease other than osteoporosis (e.g. Paget's disease); Uncontrolled hypertension without therapy or uncontrolled despite ongoing antihypertensive therapy (blood pressure ≥ 140/90 mmHg); Chronic liver disease (Child classifications B and C ); Patients with hypocalcemia, defined as plasma calcium corrected for albumin < 8.8 mg/dL; Uncontrolled hypercholesterolemia without therapy or uncontrolled despite ongoing cholesterol-lowering therapy (LDL ≥ 116 mg/dl); Chronic renal failure stages IIIb-IV-V (eGFR < 45 ml/min according to CKD-EPI); 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; Active neoplasms (including patients in remission for more than 5 years); Alcohol consumption (more than 2 units of alcohol/day); Active smoking; Active endocrinopathies (except subclinical hypothyroidism).

EU CTIS 2025-522592-29-00