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

NCT ID: NCT03755193

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-24

Study Completion Date

2026-11-23

Brief Summary

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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

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SERM plus ELD

To examine the effects of SERM plus ELD in osteoporosis patients

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

To examine the effects of SERM and ELD in osteoporosis patients

Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

Intervention Type DRUG

To examine the effects of BP and ELD in osteoporosis patients

ELD "Edirol®Tablet 0.75ug"

Intervention Type DRUG

To examine the effects of ELD in osteoporosis patients

BP plus ELD

To examine the effects of BP plus ELD in osteoporosis patients

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

To examine the effects of SERM and ELD in osteoporosis patients

Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

Intervention Type DRUG

To examine the effects of BP and ELD in osteoporosis patients

ELD "Edirol®Tablet 0.75ug"

Intervention Type DRUG

To examine the effects of ELD in osteoporosis patients

ELD alone

To examine the effects of ELD alone in osteoporosis patients

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

To examine the effects of SERM and ELD in osteoporosis patients

Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

Intervention Type DRUG

To examine the effects of BP and ELD in osteoporosis patients

ELD "Edirol®Tablet 0.75ug"

Intervention Type DRUG

To examine the effects of ELD in osteoporosis patients

Interventions

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

To examine the effects of SERM and ELD in osteoporosis patients

Intervention Type DRUG

Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

To examine the effects of BP and ELD in osteoporosis patients

Intervention Type DRUG

ELD "Edirol®Tablet 0.75ug"

To examine the effects of ELD in osteoporosis patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* osteoporosis patients

Exclusion Criteria

* not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
Minimum Eligible Age

20 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shinshu University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Nakamura

Lecturer at Shinshu University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yukio Nakamura

Matsumoto, Nagano, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yukio Nakamura

Role: CONTACT

+81263372576

Facility Contacts

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Yukio Nakamura, MD, PhD

Role: primary

+81-263-37-2659

Other Identifiers

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DMAb switch 2018

Identifier Type: -

Identifier Source: org_study_id

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