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

Phase 2RecruitingNCT03755193

Shinshu University90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoporosis

Interventions

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

To examine the effects of SERM and ELD in osteoporosis patients

Bisphosphonates and ELD "Edirol®Tablet 0.75ug"DRUG

To examine the effects of BP and ELD in osteoporosis patients

ELD "Edirol®Tablet 0.75ug"DRUG

To examine the effects of ELD in osteoporosis patients

Eligibility

Sex: ALLMin age: 20 YearsMax age: 120 Years

Medical Language ↔ Plain English

Inclusion Criteria: * osteoporosis patients Exclusion Criteria: * not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Locations (1)

Yukio Nakamura

Matsumoto, Nagano, Japan

RECRUITING

Outcomes

Primary Outcomes

Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone

Time frame: Change from Baseline Values of bone mineral density at 2 years in each group

Central Contacts

Yukio Nakamura

CONTACT

+81263372576 yxn14@aol.jp

Data from ClinicalTrials.gov

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