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

NCT03755193 — Phase 2, Recruiting, 90 participants, Shinshu University

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

Registry	NCT03755193
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	90 (Estimated)
Sponsor	Shinshu University (Other)
Conditions	Osteoporosis
Interventions	SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug", ELD "Edirol®Tablet 0.75ug" (Drug)
Dates	start 2018-11-24, primary completion 2024-11-23 (estimated), completion 2026-11-23 (estimated), first posted 2018-11-27, last updated 2021-09-21
Locations	1 site in Japan

-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

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+Arms and interventions

Arm	Type	Interventions	Description
SERM plus ELD	Active comparator	Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"; Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"; Drug: ELD "Edirol®Tablet 0.75ug"	To examine the effects of SERM plus ELD in osteoporosis patients
BP plus ELD	Active comparator	Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"; Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"; Drug: ELD "Edirol®Tablet 0.75ug"	To examine the effects of BP plus ELD in osteoporosis patients
ELD alone	Active comparator	Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"; Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"; Drug: ELD "Edirol®Tablet 0.75ug"	To examine the effects of ELD alone in osteoporosis patients

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

+Outcome measures

Primary outcomes

Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone [Change from Baseline Values of bone mineral density at 2 years in each group]

+Eligibility

Sex: All, ages: 20 Years to 120 Years

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)

Facility	City	Country	Status
Yukio Nakamura	Matsumoto, Nagano	Japan	Recruiting

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