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

S

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

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"

Trial contacts and locations

1

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Central trial contact

Yukio Nakamura

Data sourced from clinicaltrials.gov

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