Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
Primary Purpose
Osteoporosis
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"
Bisphosphonates and ELD "Edirol®Tablet 0.75ug"
ELD "Edirol®Tablet 0.75ug"
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- osteoporosis patients
Exclusion Criteria:
- not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
Sites / Locations
- Yukio NakamuraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
SERM plus ELD
BP plus ELD
ELD alone
Arm Description
To examine the effects of SERM plus ELD in osteoporosis patients
To examine the effects of BP plus ELD in osteoporosis patients
To examine the effects of ELD alone in osteoporosis patients
Outcomes
Primary Outcome Measures
Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
Secondary Outcome Measures
Full Information
NCT ID
NCT03755193
First Posted
November 23, 2018
Last Updated
September 20, 2021
Sponsor
Shinshu University
1. Study Identification
Unique Protocol Identification Number
NCT03755193
Brief Title
Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
Official Title
Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2018 (Actual)
Primary Completion Date
November 23, 2024 (Anticipated)
Study Completion Date
November 23, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shinshu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:
SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SERM plus ELD
Arm Type
Active Comparator
Arm Description
To examine the effects of SERM plus ELD in osteoporosis patients
Arm Title
BP plus ELD
Arm Type
Active Comparator
Arm Description
To examine the effects of BP plus ELD in osteoporosis patients
Arm Title
ELD alone
Arm Type
Active Comparator
Arm Description
To examine the effects of ELD alone in osteoporosis patients
Intervention Type
Drug
Intervention Name(s)
SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"
Intervention Description
To examine the effects of SERM and ELD in osteoporosis patients
Intervention Type
Drug
Intervention Name(s)
Bisphosphonates and ELD "Edirol®Tablet 0.75ug"
Intervention Description
To examine the effects of BP and ELD in osteoporosis patients
Intervention Type
Drug
Intervention Name(s)
ELD "Edirol®Tablet 0.75ug"
Intervention Description
To examine the effects of ELD in osteoporosis patients
Primary Outcome Measure Information:
Title
Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
Time Frame
Change from Baseline Values of bone mineral density at 2 years in each group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
osteoporosis patients
Exclusion Criteria:
not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukio Nakamura
Phone
+81263372576
Email
yxn14@aol.jp
Facility Information:
Facility Name
Yukio Nakamura
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
Phone
+81-263-37-2659
Email
yxn14@aol.jp
First Name & Middle Initial & Last Name & Degree
Yukio Nakamura, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
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