Ibandronate vs. Zoledronic Acid After Denosumab: Is Either Equal for Postmenopausal Osteoporosis?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open-label, randomized non-inferiority trial in postmenopausal women with osteoporosis who previously received denosumab for 1–3 years. Participants are randomized to receive one year of either ibandronate IV or zoledronic acid IV, starting about six months after their last denosumab dose. The study aims to see if ibandronate is not worse than zoledronic acid at maintaining bone health after denosumab discontinuation, providing preliminary evidence to guide future longer-term research. Primary endpoints focus on fracture risk and changes in bone turnover and density. The trial targets individuals with specific BMD ranges and excludes those with recent fragility fractures or prior related therapies beyond denosumab.

Why it matters

Who can join: the full rules

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).

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Fon-Yih Tsuang Clinical Associate Professor, Ph.D
• Email: k880113a@gmail.com
• Phone: 886-2312-3456 Ext. 265956

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two treatment regimens for osteoporosis in postmenopausal women

  This study is testing two different treatment plans for osteoporosis in postmenopausal women to see which one helps improve bone strength and reduce the risk of fractures better.

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• Zoledronate options after stopping denosumab in postmenopausal osteoporosis.

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• Preventing bone loss in critically ill adults using medications

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.