Do bisphosphonate medications improve bone health in patients on dialysis

A double blind, randomised controlled pilot study of the effect of an oral bisphosphonate versus placebo on parameters associated with fracture risk in patients on dialysis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000321943

Acronym

Study to Assess Bone after Risedronate in ESKD SABRE

Enrollment

122

Registered

2020-03-09

Start date

2022-02-24

Completion date

2025-10-21

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We hypothesise that in patients on dialysis, with normal or elevated bone turnover, the use of bisphosphonates will improve some or all of BMD, the trabecular bone score (indicating changes to bone microarchitectural parameters), cortical parameters and the buckling ratio assessed by hip structural analysis, and 3D-Shaper hip parameters that independently assess cancellous and cortical compartments from DXA images. If improvements in these parameters are seen with bisphosphonates, a larger study with fracture outcomes is proposed

Interventions

The bisphosphonate risedronate 35 mg (Actonel EC) or identical placebo given orally once weekly after a haemodialysis session. The tablet will be given to the patient by a staff member within 1 hour of th3e completion of the dialysis session. The duration of treatment will be 12 months from commencement of the study.

The bisphosphonate risedronate 35 mg (Actonel EC) or identical placebo given orally once weekly after a haemodialysis session. The tablet will be given to the patient by a staff member within 1 hour of the completion of the dialysis session. The duration of treatment will be 12 months from commencement of the study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

age 50 and over Satellite haemodialysis

Exclusion criteria

Planned parathyroid surgery Planned living related kidney transplant surgery within 12 months Active non skin malignancy Bilateral hip replacement making DXA hip bone mineral density impossible and hip structural analysis impossible Gastro oesophageal reflux or gastritis or peptic ulcer disease symptoms that are not controlled with regular medications A serum parathyroid hormone (PTH) level less than 2 times the upper normal range of the intact-PTH assay A serum alkaline phosphatase (ALP) level below the normal lower range Inability to provide informed consent

Outcome results