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

Primary Purpose

Osteoporosis, Bone Mineral Density

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Denosumab
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, denosumab, zoledronic acid

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital, Yunlin branchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Persistent treatment of Denosumab:

Alternating treatment of Denosumab and Zoledronic acid

Arm Description

persistent denosumab for 7 years

alternating treatment of Denosumab and Zoledronic acid for 7 years

Outcomes

Primary Outcome Measures

Bone mineral density of femoral neck Bone mineral density of femoral neck
Bone mineral density of femoral neck

Secondary Outcome Measures

Bone mineral density of lumbar spine
Bone mineral density of lumbar spine
Bone mineral density of total hip
Bone mineral density of total hip

Full Information

First Posted
October 11, 2021
Last Updated
October 22, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05091086
Brief Title
The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy
Official Title
The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2021 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Bone Mineral Density
Keywords
Osteoporosis, denosumab, zoledronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Persistent treatment of Denosumab:
Arm Type
Active Comparator
Arm Description
persistent denosumab for 7 years
Arm Title
Alternating treatment of Denosumab and Zoledronic acid
Arm Type
Experimental
Arm Description
alternating treatment of Denosumab and Zoledronic acid for 7 years
Intervention Type
Drug
Intervention Name(s)
Denosumab
Other Intervention Name(s)
Zoledronic acid
Intervention Description
Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab
Primary Outcome Measure Information:
Title
Bone mineral density of femoral neck Bone mineral density of femoral neck
Description
Bone mineral density of femoral neck
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Bone mineral density of lumbar spine
Description
Bone mineral density of lumbar spine
Time Frame
7 years
Title
Bone mineral density of total hip
Description
Bone mineral density of total hip
Time Frame
7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal women or men over 50 years old Denosumab treatment for at least two years and less than three years (up to five doses). Exclusion Criteria: . Estimated glomerular filtration rate <35 ml/min. Malignancy Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism Secondary osteoporosis Metabolic bone diseases Contraindications to ZOL Patients older than 80 years old Hypocalcemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shau-Huai Fu, Doctor
Phone
+886972655734
Email
b90401045@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-Yu Wang, Doctor
Phone
+886952489782
Email
valinawang0220@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital, Yunlin branch
City
Douliu
State/Province
Yunlin County
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shau-Huai Fu, Doctor
Phone
+886972655734
Email
b90401045@gmail.com
First Name & Middle Initial & Last Name & Degree
Chen-Yu Wang, Doctor
Phone
+886952489782
Email
valinawang0220@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
After application

Learn more about this trial

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

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