The Optimal Sequential Therapy After Long Term Denosumab Treatment

Last updated: November 16, 2025
Sponsor: National Taiwan University Hospital
Overall Status: Completed

Phase

4

Condition

Osteoporosis

Treatment

Alendronate and Zoledronate

zoledronate

Clinical Study ID

NCT05091099
202108044MINA
  • Ages 50-85
  • All Genders

Study Summary

This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Postmenopausal women or men over 50 years old

  2. Continuous Denosumab treatment for at least three years (up to six doses).

Exclusion

Exclusion Criteria:

  1. Secondary osteoporosis

  2. Metabolic bone diseases

  3. Active or prior malignancy

  4. Ongoing systemic glucocorticoid therapy

  5. Current use of hormone replacement therapy

  6. Current use of any medication known to affect bone metabolism

  7. Prior use of any osteoporosis medication other than denosumab

  8. Estimated glomerular filtration rate (eGFR) < 40 mL/min

  9. Known hypersensitivity to zoledronic acid

  10. Hypocalcemia

  11. Any other contraindication to zoledronic acid

  12. Age > 85 years

  13. Esophageal abnormalities that delay esophageal emptying (e.g., esophageal stricture,achalasia)

  14. Inability to stand or sit upright for at least 30 minutes

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Alendronate and Zoledronate
Phase: 4
Study Start date:
January 10, 2022
Estimated Completion Date:
November 14, 2025

Study Description

This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Connect with a study center

  • National Taiwan University Hospital, Yunlin branch

    Douliu, Yunlin County 640
    Taiwan

    Site Not Available

  • National Taiwan University Hospital, Yunlin branch

    Douliu 1665196, Yunlin County 640
    Taiwan

    Site Not Available

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