Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

September 20, 2021 updated by: Yukio Nakamura, Shinshu University

Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yukio Nakamura
  • Phone Number: +81263372576
  • Email: yxn14@aol.jp

Study Locations

  • Japan
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Recruiting
        • Yukio Nakamura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • osteoporosis patients

Exclusion Criteria:

  • not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SERM plus ELD
To examine the effects of SERM plus ELD in osteoporosis patients
Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"
To examine the effects of SERM and ELD in osteoporosis patients
Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"
To examine the effects of BP and ELD in osteoporosis patients
Drug: ELD "Edirol®Tablet 0.75ug"
To examine the effects of ELD in osteoporosis patients
Active Comparator: BP plus ELD
To examine the effects of BP plus ELD in osteoporosis patients
Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"
To examine the effects of SERM and ELD in osteoporosis patients
Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"
To examine the effects of BP and ELD in osteoporosis patients
Drug: ELD "Edirol®Tablet 0.75ug"
To examine the effects of ELD in osteoporosis patients
Active Comparator: ELD alone
To examine the effects of ELD alone in osteoporosis patients
Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"
To examine the effects of SERM and ELD in osteoporosis patients
Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"
To examine the effects of BP and ELD in osteoporosis patients
Drug: ELD "Edirol®Tablet 0.75ug"
To examine the effects of ELD in osteoporosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change from Baseline Values of bone mineral density at 2 years in each group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shinshu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2018

Primary Completion (Anticipated)

November 23, 2024

Study Completion (Anticipated)

November 23, 2026

Study Registration Dates

First Submitted

November 23, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMAb switch 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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