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An open label randomized controlled trial on the preemptive risedronate intervention for glucocorticoid-induced osteoporosis in chronic kidney disease patients

An open label randomized controlled trial on the preemptive risedronate intervention for glucocorticoid-induced osteoporosis in chronic kidney disease patients - The Preemptive Risedronate Intervention for those Undergoing Steroid therapy with Chronic Kidney Diseases (PRIUS-CKD Study )

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000387
Enrollment
100
Registered
2006-04-01
Start date
2003-08-01
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 in CKD patients

Interventions

Active vitamin D alone (1 year) Active vitamin D + risedronate (1 year) Risedronate alone (1 year)

Sponsors

Department of Nephrology, Osaka University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Outpatients with chronic kidney diseases in the nephrology unit of Osaka University Hospital who have been receiving glucocorticoid (2.5mg/day of prednisolone equivalent or greater) for more than 6 months. Creatinine clearance equal to or over 30 mL/min is required for the inclusion.

Exclusion criteria

Exclusion criteria: Patients receiving specific treatments that affect bone and mineral metabolism such as SERM, HRT, calcitonin, recombinant human PTH, and other bisphosphonate, except for active vitamin D. Patients in or expecting pregnancy

Design outcomes

Primary

MeasureTime frame
Change in bone mineral density at one year interval

Secondary

MeasureTime frame
Changes in bone turnover markers, PTH, and indices of renal function. Safety. Compliance

Countries

Japan

Contacts

Public ContactTakahito Ito

Osaka University School of Medicine Department of Nephrology

taka@medone.med.osaka-u.ac.jp06-6879-3632

Outcome results

None listed

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