Transplant Trial Watch

Effect of denosumab on trabecular bone score in de novo kidney transplant recipients.

Bonani, M., Frey, D. et al. (2019).

Nephrology Dialysis Transplantation;[record in progress].


Aims
To identify the trabecular bone score (TBS) in the POSTOP study population at baseline and after 12months, and to explore the effect of TBS changes with lumbar spine and total hip BMD changes, and changes in HRpQCT parameters, in both denosumab-treated and control patients.

Interventions
Patients were randomised to denosumab (60 mg subcutaneously at baseline and after 6months) or no treatment.

Participants
90 kidney transplant recipients.

Outcomes
Outcomes were assessed as relationship between TBS and total hip areal bone mineral density, relationship between TBS and peripheral bone microarchitecture and strength at baseline and effect of denosumab on TBS changes.

Follow-up
6.6 Years.

CET Conclusions
This manuscript reports a post-hoc analysis of an RCT of the RANKL inhibitor denosumab in kidney transplant recipients. The authors retrospectively assessed trabecular bone score (TBS) in a subset of 44 patients from the original 90. They report that baseline TBS is low in renal transplant recipients, and that it improves with treatment although the changes do not reach statistical significance. Assessment of TBS was blinded, but risk of selection bias remains with only half of the originally randomized patients included in this study. It remains to be seen whether the changes in TBS are sustained, and whether they translate into a real reduction in fracture incidence over time.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
Clinical.Trials.gov - NCT01377467

Funding source
Non-industry funded