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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
Shinshu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

20 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 23, 2018
Last Updated
September 20, 2021
Sponsor
Shinshu University
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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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