Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation

Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation - Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036853

Enrollment

Registered

2019-05-27

Start date

2019-05-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

osteoporosis

Interventions

romosozumab group romosozumab + eldecalcidol group romosozumab + alfacalcidol group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1:Osteoporosis patients who are more than 20 years old 2:Patients who agree with this study

Exclusion criteria

Exclusion criteria: 1:Patients who are allergic to romosozumab or eldecalcidol or alfacalcidol 2:Pregnant or breast-feeding patients 3:Hypocalcemia 4:Patients with severe renal function (eGFR 30 ml / min / 1.73 m2) or patients undergoing dialysis 5:Patients at risk of hypercalcemia (patients with renal dysfunction, patients with malignancy, patients with primary hyperparathyroidism) 6:Patients with severe liver dysfunction 7:Patients with urolithiasis and patients with a history of their history 8:Others, patients judged by the research director as inappropriate

Design outcomes

Primary

Measure	Time frame
Bone mineral density changes before and 6 months and 12monthsafter start of treatment	—

Secondary

Measure	Time frame
Occurrence of hypocalcemia Other adverse event	—

Countries

Japan

Contacts

Public ContactYukio Nakamura

Shinshu University School of Medicine Dept. of Orthopaedic Surgery

yxn14@aol.jp0263372659

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026