Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients
Authors' conclusion
Denosumab was associated with a markedly higher incidence of severe and very severe hypocalcemia in female dialysis-dependent patients aged 65 years or older compared with oral bisphosphonates.
Study context
- Population
- Female dialysis-dependent Medicare patients aged ≥65 years initiating denosumab or oral bisphosphonates for osteoporosis, 2013–2020
- Participants
- 1,523 vs 1,281
- Exposure
- Denosumab 60 mg vs oral bisphosphonates
- Denosumabn = 1,523
- Oral bisphosphonatesn = 1,281reference
- Outcome
- Severe hypocalcemia: total albumin-corrected serum calcium below 7.5 mg/dL (1.88 mmol/L) or primary hospital or ED hypocalcemia diagnosis (emergent care)
- Follow-up
- First 12 treatment weeks
Methodological detailsinverse probability of treatment-weighted, Monthly serum calcium obtained through linkage to the Consolidated Renal Operations in a Web-Enabled Network database
- Inverse probability of treatment-weighted
- Monthly serum calcium obtained through linkage to the Consolidated Renal Operations in a Web-Enabled Network database
Main finding
As reported in the abstract
Severe hypocalcemia, weighted cumulative incidence · 12 weeks
Each group vs oral bisphosphonatesWeighted risk difference (95% CI)
Denosumab
39.1%(36.3%–41.9%)
Each group vs oral bisphosphonatesWeighted relative risk (95% CI)
Denosumab
20.7(13.2–41.2)
Observational data: associations, not effects.
Further findings
| Outcome | Denosumab | Oral bisphosphonates | Weighted risk difference (95% CI) | |
|---|---|---|---|---|
| Very severe hypocalcemia (serum calcium below 6.5 mg/dL [1.63 mmol/L] or emergent care), weighted cumulative incidence · 12 weeks | 10.9% | 0.4% | 10.5% (8.8%–12.0%) | |
| −5051015Difference (linear scale) |
| Outcome | Weighted RR (95% CI) | |
|---|---|---|
| Very severe hypocalcemia (serum calcium below 6.5 mg/dL [1.63 mmol/L] or emergent care), weighted cumulative incidence · 12 weeks | 26.4 (9.7–449.5) | |
| 0.050.21520Weighted relative risk (log scale) |
Original publication
Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients. JAMA. Published 13 February 2024. doi:10.
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