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An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid

An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid - The Preemptive Risedronate Intervention for those Undergoing Steroid therapy after Renal Transplantation (PRIUS-RTx Study)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000391
Enrollment
50
Registered
2006-04-01
Start date
2003-11-01
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

Bone disease in renal transplant patients receiving glucocorticoid

Interventions

Active vitamin D alone (2 year) Active vitamin D + risedronate (2 year)

Sponsors

Department of Advanced Technology for Transplantation, Osaka University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Renal transplant patients receiving glucocorticoid treatment (2.5 mg/day of prednisolone equivalent or greater) with low bone mineral density (T-score at the lumbar spine <= -1.0) and stable renal function (serum creatinine <= 2.0 mg/dL).

Exclusion criteria

Exclusion criteria: 1. Previous history of bisphosphonate treatment and/or hormone replacement therapy within one year before entry 2. Contraindication for risedronate or active vitamin D 3. Not suitable to the clinical trial as judged by a physician

Design outcomes

Primary

MeasureTime frame
Change in bone mineral density and bone turnover markers at two-year interval—

Secondary

MeasureTime frame
Ca, iP, PTH, and indices of renal function. Safety.—

Countries

Japan

Outcome results

None listed

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