CLINICAL TRIALS PROFILE FOR ELDECALCITOL

Clinical Trials for Eldecalcitol

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01974167 ↗	Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol	Unknown status	e-GLORIA trial Protocol Review Committee	N/A	The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label, parallel-group, comparative design.
NCT02306187 ↗	The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis	Recruiting	Shinshu University	Phase 1	In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.
NCT03755193 ↗	Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients	Recruiting	Shinshu University	Phase 2	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
NCT05406050 ↗	Bioequivalence Study of Eldecalcitol Soft Capsule in Healthy Chinese Subjects	Completed	Wenzhou Haihe Pharmaceutical Co., Ltd.	Phase 1	A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy Chinese subjects under fasting conditions.
NCT05406050 ↗	Bioequivalence Study of Eldecalcitol Soft Capsule in Healthy Chinese Subjects	Completed	The Affiliated Hospital of Qingdao University	Phase 1	A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy Chinese subjects under fasting conditions.
NCT05884372 ↗	Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.	Not yet recruiting	Chugai Pharma China Co., Ltd.	Phase 4	Primary objective: To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density. Secondary objective: To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life.

Clinical Trial Conditions for Eldecalcitol

Condition Name

Condition Name
Intervention	Trials
Osteoporosis	3
Healthy	1
Low Bone Mineral Density	1
Osteoporosis in Postmenopausal Women	1

Condition MeSH

Condition MeSH
Intervention	Trials
Osteoporosis	5
Osteoporosis, Postmenopausal	1
Bone Diseases, Metabolic	1

Clinical Trial Locations for Eldecalcitol

Trials by Country

Trials by Country
Location	Trials
Japan	3
China	2

Clinical Trial Progress for Eldecalcitol

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	2
Unknown status	1

Clinical Trial Sponsors for Eldecalcitol

Sponsor Name

Sponsor Name
Sponsor	Trials
Chugai Pharma China Co., Ltd.	2
Shinshu University	2
Xi'an Honghui Hospital	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Other	8
Industry	1