Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2018
CompletedStudy Start
First participant enrolled
November 24, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2026
ExpectedSeptember 21, 2021
September 1, 2021
6 years
November 23, 2018
September 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
SERM plus ELD
ACTIVE COMPARATORTo examine the effects of SERM plus ELD in osteoporosis patients
BP plus ELD
ACTIVE COMPARATORTo examine the effects of BP plus ELD in osteoporosis patients
ELD alone
ACTIVE COMPARATORTo examine the effects of ELD alone in osteoporosis patients
Interventions
To examine the effects of SERM and ELD in osteoporosis patients
To examine the effects of BP and ELD in osteoporosis patients
To examine the effects of ELD in osteoporosis patients
Eligibility Criteria
You may qualify if:
- osteoporosis patients
You may not qualify if:
- not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yukio Nakamura
Matsumoto, Nagano, 3908621, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer at Shinshu University School of Medicine
Study Record Dates
First Submitted
November 23, 2018
First Posted
November 27, 2018
Study Start
November 24, 2018
Primary Completion
November 23, 2024
Study Completion (Estimated)
November 23, 2026
Last Updated
September 21, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share