Romosozumab versus denosumab and heart artery changes in women with osteoporosis after menopause

Who can take part

• 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

Who cannot take part

• 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)