The Optimal Sequential Therapy After Long Term Denosumab Treatment

November 16, 2025 updated by: National Taiwan University Hospital
This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Yunlin County
      • Douliu, Yunlin County, Taiwan, 640
        • National Taiwan University Hospital, Yunlin branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: On time Zoledronate
Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
Drug: zoledronate
On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
Other Names:
  • Zoledronic acid
Experimental: Alendronate and Zoledronate
Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose).
Drug: Alendronate and Zoledronate
Alendronate and Zoledronate: Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density of lumbar spine
Time Frame: one year
Bone mineral density of lumbar spine
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density of femoral neck
Time Frame: one year
Bone mineral density of femoral neck
one year
Bone mineral density of total hip
Time Frame: one year
Bone mineral density of total hip
one year
bone turnover markers
Time Frame: 13 months
Changes of C-terminal telopeptide of type I collagen (CTX) and propeptide of procollagen type I (P1NP)
13 months
clinical osteoporotic fracture
Time Frame: 1 year
any incidence of clinical osteoporotic fracture
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

November 14, 2025

Study Completion (Actual)

November 14, 2025

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Estimated)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202108044MINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

after application

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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