The Effect of Denosumab on Risk for Emergently Treated Hypocalcemia by Stage of Chronic Kidney Disease : A Target Trial Emulation
Authors' conclusion
Risk for emergently treated hypocalcemia with denosumab increased with worsening CKD stage and was highest in DD patients and those with CKD-MBD.
Study context
- Population
- Female patients aged ≥65 years initiating osteoporosis treatment; Medicare fee-for-service data with prescription drug coverage, 2012 to 2020
- Participants
- 361,453 / 829,044 / 160,413
- Comparison
- Denosumab vs oral bisphosphonates, by chronic kidney disease (CKD) stage and CKD-mineral and bone disorder (CKD-MBD)
- Denosumabn = 361,453
- Oral bisphosphonatesn = 829,044reference
- Intravenous (IV) bisphosphonatesn = 160,413
- Outcome
- Hospital and ED admissions (emergent care) for hypocalcemia
- Follow-up
- First 12 treatment weeks
Methodological detailsinverse probability of treatment weighting
- Inverse probability of treatment weighting
Main finding
As reported in the abstract
Emergently treated hypocalcemia by CKD stage, weighted cumulative incidence
Denosumab vs Oral bisphosphonatesEstimate (95% CI)
Dialysis-dependent
RD (dialysis-dependent: 3.01% vs. 0.00%) 3.01%(2.27%–3.77%)
Non-dialysis-dependent CKD stages 4 and 5
RD (NDD CKD stages 4 and 5: 0.57% vs. 0.03%) 0.54%(0.41%–0.68%)
- Risk with denosumab vs oral bisphosphonates increased with worsening CKD stage
- P < 0.001
Further findings
| Outcome | Estimate | |
|---|---|---|
| Emergently treated hypocalcemia in CKD stages 4 and 5 (NDD + DD), by CKD-MBD (subgroup) · first 12 treatment weeksDenosumabvs Oral bisphosphonatesWith CKD-MBD | RD (with CKD-MBD: 1.53% vs. 0.02%) 1.51% (CI 1.21%–1.78%) | |
| Emergently treated hypocalcemia in CKD stages 4 and 5 (NDD + DD), by CKD-MBD (subgroup) · first 12 treatment weeksDenosumabvs Oral bisphosphonatesWithout CKD-MBD | RD (without CKD-MBD: 0.22% vs. 0.03%) 0.19% (CI 0.08%–0.31%) | |
| −1012Difference (linear scale) |
Emergently treated hypocalcemia, denosumab vs IV bisphosphonates
- Denosumab also showed increased risk compared with IV bisphosphonates
Original publication
The Effect of Denosumab on Risk for Emergently Treated Hypocalcemia by Stage of Chronic Kidney Disease : A Target Trial Emulation. Ann Intern Med. Published 19 November 2024. doi:10.
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