Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis

Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis - Evaluation of efficacy and safety of romosozumab for osteoporosis in HD patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037579

Enrollment

Registered

2019-08-02

Start date

2019-08-02

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, end stage renal disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patient undergoing hemodialysis for more than 3 months 2) patient with osteoporosis who is scheduled to receive monthly subcutaneous romosozumab therapy 3) patient who is competent to understand the aim of this study and agree on it

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in bone mineral density at month 12	—

Secondary

Measure	Time frame
Monthly serum calcium and phosphate levels Serum intact PTH, FGF23, BAP and TRACP5b levels at month 1, month 3, month 6, month 9 and month 12 Percent change of aortic calcification score from baseline	—

Countries

Japan

Contacts

Public ContactNaoto Hamano

Tokai University School of Medicine Division of Nephrology, Endocrinology and Metabolism

nhamano@tokai.ac.jp0463-93-1121

Outcome results