The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation: A Randomized Non-inferiority Trial
This study is a prospective, multicenter, open-label, randomized non-inferiority trial comparing intravenous ibandronate and zoledronic acid as sequential therapy after denosumab discontinuation in postmenopausal women with osteoporosis. This trial primarily targets patients with short-term denosumab exposure (less than three years) and is conducted as a preliminary investigation. The findings are expected to provide foundational evidence to inform the design of future studies assessing sequential therapies following longer-term denosumab treatment.
• Postmenopausal women aged 50 to 85 years.
• BMD T-score ≤ -1.5 and \> -3.0 at the lumbar spine or total hip.
• Regular treatment with denosumab administered every 6 months for at least 1 year and less than 3 years (3 to 5 doses).
• Physically and mentally capable of understanding and complying with the study protocol and follow-up.
• Signed informed consent.