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Clinical Trials in Japan / NCT03755193
Recruiting Phase 2

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

NCT03755193 · tracked via the Priya Life Science Japan tracker
Sponsor
Shinshu University
Phase
Phase 2
Started
2018-11-24
Last updated
2021-09-21

Condition(s) studied

Osteoporosis

Investigational drug(s) / intervention(s)

SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"Bisphosphonates and ELD "Edirol®Tablet 0.75ug"ELD "Edirol®Tablet 0.75ug"

SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug": To examine the effects of SERM and ELD in osteoporosis patients

Bisphosphonates and ELD "Edirol®Tablet 0.75ug": To examine the effects of BP and ELD in osteoporosis patients

ELD "Edirol®Tablet 0.75ug": To examine the effects of ELD in osteoporosis patients

Study 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

Eligibility

Sex
ALL
Min age
20 Years
Max age
120 Years
Healthy volunteers
No
Inclusion Criteria: * osteoporosis patients Exclusion Criteria: * not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Primary outcome measure(s)

  • Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone — Change from Baseline Values of bone mineral density at 2 years in each group

Trial sites (1)

FacilityCityRegionStatus
Yukio Nakamura Matsumoto Nagano Recruiting

More Shinshu University trials in Japan

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Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA Recruiting

Other trials for the same condition

The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures Recruiting
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03755193 on ClinicalTrials.gov ↗ ← All trials in Japan