Romosozumab for Postmenopausal osteoporosis | Coronary atherosclerosis

Inclusion criteria

• {"criterion_text":"- female patients"}
• {"criterion_text":"- Patients who need to initiate treatment with Romosozumab or Denosumab in accordance with the prescribing criteria for each drug as established by AIFA Note 79."}
• {"criterion_text":"- patients on secondary prophylaxis"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Patients who sign the Informed Consent Form for participation in the study"}

Exclusion criteria

• {"criterion_text":"- Diabetes mellitus"}
• {"criterion_text":"- History of bone disease other than osteoporosis (e.g. Paget's disease)"}
• {"criterion_text":"- Active neoplasms (including patients in remission for more than 5 years)"}
• {"criterion_text":"- Previous acute myocardial infarction (AMI) and/or stroke, regardless of age of onset"}
• {"criterion_text":"- Alcohol consumption (more than 2 units of alcohol/day)"}
• {"criterion_text":"- Active smoking"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients with hypocalcemia, defined as plasma calcium corrected for albumin < 8.8 mg/dL."}
• {"criterion_text":"- Previous allergic reaction to iodinated contrast media or allergy or hypersensitivity to the study drugs (active substance and excipients)"}
• {"criterion_text":"- Concomitant steroid or immunosuppressive therapy or other drugs known to interfere with bone metabolism"}
• {"criterion_text":"- Women ≤ 69 years: cardiovascular risk ≥ 20% at 10 years according to the Heart Project risk charts"}
• {"criterion_text":"- Women ≥ 70 years: 2OP score (ESC 2021) with risk > 15% at 10 years"}
• {"criterion_text":"- Uncontrolled hypercholesterolemia without therapy or uncontrolled despite ongoing cholesterol-lowering therapy (LDL ≥ 116 mg/dl)"}
• {"criterion_text":"- Uncontrolled hypertension without therapy or uncontrolled despite ongoing antihypertensive therapy (blood pressure ≥ 140/90 mmHg)"}
• {"criterion_text":"- Active endocrinopathies (except subclinical hypothyroidism)"}
• {"criterion_text":"- Chronic renal failure stages IIIb-IV-V (eGFR < 45 ml/min according to CKD-EPI)"}
• {"criterion_text":"- Chronic liver disease (Child classifications B and C )"}

Primary endpoints

• {"endpoint_text":"- Change in the coronary CT score adapted according to the CCTA-Leaman method after 12 months of therapy.","definition_or_measurement_approach":"Coronary CT score adapted according to the CCTA-Leaman method measured by cardiac CT scan at baseline (V1) and at 12 months (V3); primary outcome is the change in this score after 12 months of therapy."}

Secondary endpoints

• {"endpoint_text":"- Change in scores: Segment Involvement Score (SIS) and Segment Stenosis Score (SSS) between V1 and V3","definition_or_measurement_approach":"SIS and SSS measured on cardiac CT at baseline (V1) and at 12 months (V3); progression assessed by change between V1 and V3."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Biomarkers measured at V1 (blood sampling) and analysed for correlation with changes in coronary CT scores."}

Italy

Earliest CTIS Part Ii Submission Date

27-10-2025

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

119

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

Ospedale Galeazzi S.p.A.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Fondazione POLIZZOTTO, Pegoraro Paolo Amedeo and IRCCS Ospedale Galeazzi Sant’Ambrogio","duties_or_roles":"Source of monetary support / funding","organisation_type":""}