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Recruiting NCT03755193

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

Phase II Interventional Osteoporosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug", ELD "Edirol®Tablet 0.75ug".
Who it may be relevant to
Registry conditions: Osteoporosis. Basic parameters: 20 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Yukio Nakamura — Matsumoto

Identifiers

NCT: NCT03755193 · DMAb switch 2018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗