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Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab

Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab - Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037123
Enrollment
60
Registered
2019-06-20
Start date
2019-06-20
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 plus active vitamin D group romosozumab + denosumab plus active vitamin D group

Sponsors

Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1:All osteoporosis patients over 20 years old or older (but does not correspond to the following exclusion criteria)3 2: Patients who have already received Denosumab (60 mg once every 6 months) for 2 years before the start of the study and have a YAM value of 70% or more or a bone density value of less than -2.5 SD 3:Patients who agree with this study

Exclusion criteria

Exclusion criteria: 1:Patients who have taken romosozumab or denosumab before 2:Patients who are allergic to romosozumab or denosumab or eldecalcitol 3:Hypocalcemia 4:Pregnant or breast-feeding patients 5:Patients with severe renal function (eGFR 30 ml / min / 1.73 m2) or patients undergoing dialysis 6:Patients at risk of hypercalcemia (patients with renal dysfunction, patients with malignancy, patients with primary hyperparathyroidism) 7:Patients with severe liver dysfunction 8:Patients with urolithiasis and patients with a history of their history

Design outcomes

Primary

MeasureTime frame
Bone mineral density at 12 months after treatment

Secondary

MeasureTime frame
Occurrence of hypocalcemia Occurrence of other adverse events

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