The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05091086
Collaborator
(none)
60
1
2
109.3
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy
Anticipated Study Start Date :
Nov 20, 2021
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Persistent treatment of Denosumab:

persistent denosumab for 7 years

Drug: Denosumab
Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab
Other Names:
  • Zoledronic acid
  • Experimental: Alternating treatment of Denosumab and Zoledronic acid

    alternating treatment of Denosumab and Zoledronic acid for 7 years

    Drug: Denosumab
    Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab
    Other Names:
  • Zoledronic acid
  • Outcome Measures

    Primary Outcome Measures

    1. Bone mineral density of femoral neck Bone mineral density of femoral neck [7 years]

      Bone mineral density of femoral neck

    Secondary Outcome Measures

    1. Bone mineral density of lumbar spine [7 years]

      Bone mineral density of lumbar spine

    2. Bone mineral density of total hip [7 years]

      Bone mineral density of total hip

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Postmenopausal women or men over 50 years old

    2. Denosumab treatment for at least two years and less than three years (up to five doses).

    Exclusion Criteria:
    1. . Estimated glomerular filtration rate <35 ml/min.

    2. Malignancy

    3. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism

    4. Secondary osteoporosis

    5. Metabolic bone diseases

    6. Contraindications to ZOL

    7. Patients older than 80 years old

    8. Hypocalcemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital, Yunlin branch Douliu Yunlin County Taiwan 640

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05091086
    Other Study ID Numbers:
    • 202107164MINC
    First Posted:
    Oct 25, 2021
    Last Update Posted:
    Oct 25, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 25, 2021