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NCT03755193 Clinical Trial

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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03755193
Other study ID # DMAb switch 2018
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 24, 2018
Est. completion date November 23, 2026

Study information
Verified date September 2021
Source Shinshu University
Contact Yukio Nakamura
Phone +81263372576
Email yxn14@aol.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date November 23, 2026
Est. primary completion date November 23, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Japan Yukio Nakamura Matsumoto Nagano

Sponsors (1)
Lead Sponsor Collaborator
Shinshu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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