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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037239
Enrollment
90
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 denosumab group bisphosphonate group

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with systemic autoimmune diseases who commenced glucocorticoid therapy with prednisolone at doses over 15 mg daily 2. Patients who agree with this study

Exclusion criteria

Exclusion criteria: 1. Patients who have received romosozumab or denosumab or bisphosphonate 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

MeasureTime frame
The change of bone mineral density at 12 months after initiation of glucocorticoid therapy

Secondary

MeasureTime 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