The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation

Sponsor
National Taiwan University Hospital
Study ID
NCT07406685
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Osteoporosis
  • Postmenopausal Osteopenia
  • Postmenopausal Osteoporosis
  • Primary Osteoporosis

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibandronate IV — DRUG
    Ibandronate 3mg/3months for 12 months
  • Zoledronic acid IV — DRUG
    Zoledronic acid 5mg/1year for 12 months

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
Jan 2026
Primary completion
Mar 17, 2030
Completion
Sep 17, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibandronate group
    use Ibandronate 1 year and follow-up for 2 years
  • Active Comparator: Zoledronic acid group
    use Zoledronic acid 1 year and follow-up for 2 years

Primary Outcome Measure

Percentage change in bone mineral density (BMD) [ Time Frame: Baseline to 24 months after treatment initiation. ]

Central Contacts

  • Fon-Yih Tsuang Clinical Associate Professor, Ph.D
    886-2312-3456 Ext. 265956
    [email protected]

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