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

Shinshu University

Status and phase: Enrolling; Phase 2

Conditions: Osteoporosis

Treatments: Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"; Drug: ELD "Edirol®Tablet 0.75ug"; Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

Study type: Interventional

Funder types: Other

Identifiers

NCT03755193

DMAb switch 2018

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• osteoporosis patients

Exclusion criteria

• not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

SERM plus ELD

Active Comparator group

Description:

To examine the effects of SERM plus ELD in osteoporosis patients

Treatment:

Drug: ELD "Edirol®Tablet 0.75ug"

Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

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

BP plus ELD

Active Comparator group

Description:

To examine the effects of BP plus ELD in osteoporosis patients

Treatment:

Drug: ELD "Edirol®Tablet 0.75ug"

Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

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

ELD alone

Active Comparator group

Description:

To examine the effects of ELD alone in osteoporosis patients

Treatment:

Drug: ELD "Edirol®Tablet 0.75ug"

Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

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