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

Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03755193
Enrollment
90
Registered
2018-11-27
Start date
2018-11-24
Completion date
2026-11-23
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief summary

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

Interventions

DRUGSERM Viviant®Tablet 20mg and ELD Edirol®Tablet 0.75ug

To examine the effects of SERM and ELD in osteoporosis patients

DRUGBisphosphonates and ELD Edirol®Tablet 0.75ug

To examine the effects of BP and ELD in osteoporosis patients

DRUGELD Edirol®Tablet 0.75ug

To examine the effects of ELD in osteoporosis patients

Sponsors

Shinshu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

* osteoporosis patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD aloneChange from Baseline Values of bone mineral density at 2 years in each group

Countries

Japan

Contacts

Primary ContactYukio Nakamura
yxn14@aol.jp+81263372576

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026