Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients

Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients - Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037240

Enrollment

200

Registered

2019-07-07

Start date

2019-07-01

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

glucocorticoid-induced osteoporosis

Interventions

romosozumab group -switch from bisphosphonate- romosozumab group -switch from denosumab- bisphosphonate group denosumab group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with systemic autoimmune diseases who received bisphosphonate or denosumab for more than half a year and received glucocorticoid therapy with prednisolone at doses over 5 mg daily 2. Patients who agree with this study

Exclusion criteria

Exclusion criteria: 1. Patients who have received romosozumab 2. Patients with contraindication for romosozumab or denosumab or bisphosphonate 3. Patients with severe renal dysfunction (eGFR < 30mL/min/1.73m2) 4. Patients who is currently pregnant, breastfeeding or willing to get pregnant 5. Patients who do not give consent to the study 6. Patients who are judged to be inappropriate by the physician

Design outcomes

Primary

Measure	Time frame
The change of bone mineral density at 12 months after initiation of glucocorticoid therapy	—

Secondary

Measure	Time frame
The change of bone mineral density at 36 months after initiation of glucocorticoid therapy, the change of bone metabolism markers and adverse events during the observation period	—

Countries

Japan

Contacts

Public ContactMai Kawazoe

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

mai.kawazoe@med.toho-u.ac.jp03-3762-4151(6595)

Outcome results

None listed

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