The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

NCT05091086 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 202107164MINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis; Bone Mineral Density

Keywords

Osteoporosis; denosumab; zoledronic acid

Outcome Measures

Primary Outcomes (1)

• Change in lumbar spine bone mineral density

  From enrollment to the end of treatment at 3 years

Secondary Outcomes (7)

• 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

Study Arms (2)

Persistent treatment of Denosumab:

ACTIVE COMPARATOR

persistent denosumab for 7 years

Drug: Continuous Denosumab

Alternating treatment of Denosumab and Zoledronic acid

EXPERIMENTAL

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

Interventions

Continuous Denosumab DRUG

Active comparator: persistent treatment of denosumab.

Persistent treatment of Denosumab:

Administer zoledronate and denosumab on an alternating schedule DRUG

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.

Alternating treatment of Denosumab and Zoledronic acid

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Yunlin branch

Douliu, Yunlin county, 640, Taiwan

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital Yunlin Branch, Orthopedic department

Model Details: Two parallel group would be selected. One group of participants keep their denosumab treatment for 7 years. Another group of participants accept two cycles of treatment (one year of zoledronate and two years of denosumab) and complete with one year of zoledronate.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 25, 2021
• Study Start: November 20, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 22, 2025

Record last verified: 2025-01

Locations

TW (1)