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ATRIO Study: Effect of Romosozumab vs. Denosumab on Coronary Atherosclerotic Damage in Postmenopausal Osteoporosis: A Phase IV, Low-Risk Intervention Study.
EU CTIS ID: 2025-522592-29-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 79.
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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 79.
- 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
- 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 )
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.