Comparison of efficacy of sequential treatment with romosozumab or denosumab for bisphosphonate-resistance glucocorticoid-induced osteoporosis

Comparison of efficacy of sequential treatment with romosozumab or denosumab for bisphosphonate-resistance glucocorticoid-induced osteoporosis - RoDeO study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055105

Enrollment

100

Registered

2024-08-01

Start date

2024-12-02

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Glucocorticoid-induced osteoporosis

Interventions

Romosozumab group: Patients receive romosozumab subcutaneously with a discontinuation of bisphosphonate. After 12 months of treatment, romosozumab will be discontinued and denosumab will be started. A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients 40 years of age or older receiving glucocorticoids (prednisolone equivalent 2.5 mg/day or more) and bisphosphonates for at least 6 months. 2) Patients with a T-score of -2.0 or less in bone mineral density of the lumbar spine, femoral neck or total hip by DEXA. 3) Patients with a history of fragility fracture. 4) Patients with a probability of major osteoporotic fracture greater than or equal to 20% or a probability of proximal femoral fracture greater than or equal to 3% at 10 years by FRAX. 5) Patients who have provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with contraindications to romosozumab or denosumab. 2) Patients with active infection or malignancy. 3) Patients who are currently pregnant, lactating, or willing to get pregnant. 4) Patients who do not give consent to this study.

Design outcomes

Primary

Measure	Time frame
Compare the percent change of bone mineral density of the lumbar spine (L2-4), femoral neck and total hip at 52 weeks in the romosozumab and denosumab groups.	—

Secondary

Measure	Time frame
1) Compare the percent change of bone mineral density of the lumbar spine, femoral neck and total hip between the romosozumab and denosumab groups at 26, 78, 104, 130, and 156 weeks. 2) Compare the percent change of bone mineral density of the trochanter and the change of bone turnover markers at 26, 52, 78, 104, 130, and 156 weeks between the romosozumab and denosumab groups. 3) Compare the incidence of new fractures between the romosozumab and denosumab groups. 4) Compare the incidence of adverse events between the romosozumab and denosumab groups.	—

Measure

Time frame

1) Compare the percent change of bone mineral density of the lumbar spine, femoral neck and total hip between the romosozumab and denosumab groups at 26, 78, 104, 130, and 156 weeks. 2) Compare the percent change of bone mineral density of the trochanter and the change of bone turnover markers at 26, 52, 78, 104, 130, and 156 weeks between the romosozumab and denosumab groups. 3) Compare the incidence of new fractures between the romosozumab and denosumab groups. 4) Compare the incidence of adverse events between the romosozumab and denosumab groups.

—

Countries

Japan

Contacts

Public ContactMai Kawazoe

Toho University School of Medicine Division of Rheumatology, Department of Internal Medicine

mai.kawazoe@med.toho-u.ac.jp03-3462-4151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026