NCT07406685RecruitingPhase 4
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation: A Randomized Non-inferiority Trial
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 1 Feb 2026
- Start date
- 20 Aug 2026
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT07406685
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 52
- From 20 Aug 2026 to the primary completion date, 31 Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Requirement for long-term use of medications known to affect bone metabolism (e.g., systemic glucocorticoids or hormone therapy).
- Planned dental procedures (e.g., extractions, implants) within the next year.
Other illness
- History of fragility or osteoporotic fracture within the past 12 months.
- Allergy to bisphosphonates.
- Metabolic bone diseases.
- Any autoimmune disease.
- Cancer patients, except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years.
Lab values
- Vitamin D deficiency (serum 25-hydroxyvitamin D \< 25 ng/mL).
- Renal disease (eGFR \< 35 mL/min/1.73 m²) or dialysis patients.
Other
- Secondary osteoporosis.
- Primary or metastatic bone tumors.
- Hypocalcemia.
- Smoking more than one pack per day (except for those who have quit for over ten years).
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.