The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation

Starting soon · Phase 4

Conditions studied: Postmenopausal Osteoporosis, Postmenopausal Osteopenia, Primary Osteoporosis, Osteoporosis

In brief

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 facts

Study ID

NCT07406685

Run by

National Taiwan University Hospital

People needed

52

Starts

2026-03-17

Expected to finish

2030-09-17

Last updated by the study team

2026-02-12

Who can join

Age: 50 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Metabolic bone diseases.
• Any autoimmune disease.
• Requirement for long-term use of medications known to affect bone metabolism (e.g., systemic glucocorticoids or hormone therapy).
• Primary or metastatic bone tumors.
• Cancer patients, except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years.
• Hypocalcemia.
• Vitamin D deficiency (serum 25-hydroxyvitamin D < 25 ng/mL).
• Renal disease (eGFR < 35 mL/min/1.73 m²) or dialysis patients.
• Planned dental procedures (e.g., extractions, implants) within the next year.
• Smoking more than one pack per day (except for those who have quit for over ten years).

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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