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

ConditionOsteoporosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age20-120

SponsorShinshu University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

osteoporosis patients

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: SERM plus ELDActive comparator 3 interventions

Group B: BP plus ELDActive comparator 3 interventions

Group C: ELD aloneActive comparator 3 interventions

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shinshu University

Lead sponsor

Source ClinicalTrials.gov

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