The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Recruiting · NCT07406685 · Interventional (participants receive a specific treatment) · Lead sponsor: National Taiwan University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Ibandronate IVZoledronic acid IV
What this trial is about
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 take part
Age range
50 Years to 85 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
- 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
1 location listed.
- National Taiwan University Hospital - Taipei, Taiwan