Ibandronate IV: Ibandronate 3mg/3months for 12 months
Zoledronic acid IV: Zoledronic acid 5mg/1year for 12 months
Study 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.
Eligibility
Sex
FEMALE
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Postmenopausal women aged 50 to 85 years.
2. BMD T-score ≤ -1.5 and \> -3.0 at the lumbar spine or total hip.
3. Regular treatment with denosumab administered every 6 months for at least 1 year and less than 3 years (3 to 5 doses).
4. Physically and mentally capable of understanding and complying with the study protocol and follow-up.
5. Signed informed consent.
Exclusion Criteria:
1. History of fragility or osteoporotic fracture within the past 12 months.
2. 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.
3. Allergy to bisphosphonates.
4. Secondary osteoporosis.
5. Metabolic bone diseases.
6. Any autoimmune disease.
7. Requirement for long-term use of medications known to affect bone metabolism (e.g., systemic glucocorticoids or hormone therapy).
8. Primary or metastatic bone tumors.
9. Cancer patients, except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years.
10. Hypocalcemia.
11. Vitamin D deficiency (serum 25-hydroxyvitamin D \< 25 ng/mL).
12. Renal disease (eGFR \< 35 mL/min/1.73 m²) or dialysis patients.
13. Planned dental procedures (e.g., extractions, implants) within the next year.
14. Smoking more than one pack per day (except for those who have quit for over ten years).
Primary outcome measure(s)
Percentage change in bone mineral density (BMD) — Baseline to 24 months after treatment initiation. Change in BMD at the lumbar spine, femoral neck, and total hip measured by dual-energy X-ray absorptiometry (DXA) from baseline to 24 months.
Baseline is defined as the time point 6 months after the last dose of denosumab, immediately prior to initiation of sequential therapy. BMD measurements will be performed at 6, 12, 18, and 24 months after treatment initiation.
Trial sites (1)
Facility
City
Region
Status
National Taiwan University Hospital
Taipei
Taiwan
Recruiting
More National Taiwan University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
