The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation (NCT07406685) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Taiwan52 participantsStarted 2026-03-17
Plain-language summary
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.
Who can participate
Age range50 Years – 85 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. History of fragility or osteoporotic fracture within the past 12 months.
✕. Current or prior treatment within the past 12 months with osteoporosis medications other than denosumab, including Romosozumab, Teriparatide, Alendronate, Ibandronate, Zoledronic acid, Risedronate and Raloxifene.
✕. Allergy to bisphosphonates.
✕. Secondary osteoporosis.
✕
What they're measuring
1
Percentage change in bone mineral density (BMD)
Timeframe: Baseline to 24 months after treatment initiation.