The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoporosis; Bone Mineral Density
• Intervention / Treatment: Drug: Continuous Denosumab; Drug: Administer zoledronate and denosumab on an alternating schedule

Detailed Description

This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures.
2. Denosumab treatment for at least two years and less than three years (up to maximum of five doses).

Exclusion Criteria:

1. Secondary osteoporosis.
2. Metabolic bone diseases.
3. Malignancy.
4. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
5. Patients had ever used antiosteoporosis medications other than Dmab
6. Estimated glomerular filtration rate < 35 mL/min.
7. Allergy to Zoledronate.
8. Any other contraindications to Zoledronate use.
9. History of diagnosed hypocalcemia.
10. Age greater than 80 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Persistent treatment of Denosumab: persistent denosumab for 7 years	Drug: Continuous Denosumab; Active comparator: persistent treatment of denosumab.
Experimental: Alternating treatment of Denosumab and Zoledronic acid; Alternating treatment with denosumab and zoledronic acid over a 7-year period: after entering the trial, patients received one year of zoledronic acid, followed by two years of denosumab, then switched back to zoledronic acid for one year, followed by another two years of denosumab, and finally received one more year of zoledronic acid.	Drug: Administer zoledronate and denosumab on an alternating schedule; In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in lumbar spine bone mineral density	From enrollment to the end of treatment at 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total hip bone mineral density		From enrollment to the end of treatment at 3 years and 7 years
Change in femoral neck bone mineral density		From enrollment to the end of treatment at 3 years and 7 years
Change in lumbar spine bone mineral density		From enrollment to the end of treatment at 7 years
Change in C-terminal telopeptide of type 1 collagen		From enrollment to the end of treatment at 3 years and 7 years
Change in Procollagen type 1 N-terminal propeptide		From enrollment to the end of treatment at 3 years and 7 years
Fractures	Number of Participants with clinical fractures and radiographic vertebral fractures	3 & 7 years
Change in quality of life		From enrollment to the end of treatment at 3 years and 7 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

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 (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Osteoporosis; zoledronic acid; denosumab
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid; Denosumab
• Other Study ID Numbers: 202107164MINC

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes