The Incidence of Hypocalcemia After Denosumab Administration in Patients with CKD
Bibliographic record
Abstract
Background: Patients with chronic kidney disease (CKD) are at increased risk of fragility fracture and its complications. Denosumab is an antiresorptive agent approved for use in CKD, but has been associated with hypocalcemia in those with advanced disease although the incidence is unclear. We examine the real-world incidence of hypocalcaemia in patients with CKD newly prescribed denosumab. Methods: Using linked healthcare databases (ICES), we conducted a populationbased cohort study of adults >65 years newly prescribed denosumab or bisphosphonates from 2012-2017 in Ontario, Canada. We captured the incidence of hypocalcaemia within 180 days of drug dispensing, stratified by eGFR. Results: We identified 9,319 new users of denosumab and 9,052 new users of oral bisphosphonates. Compared with bisphosphonate users, denosumab users were older (78.8 vs 75.0 years), more often from long-term care, had a history of fragility fracture, and had more advanced CKD. Approximately one third of patients dispensed denosumab had a calcium level checked within 180 days of their prescription. The risk of hypocalcemia (<2.00mmol/L) with denosumab was low (0.74% 95% CI 0.58-0.93). One third of those had a calcium <1.8mmol/L (0.28% 95% CI (0.19-0.41). The risk of hypocalcemia increased substantially in those with eGFR <30 (8.4% [95% CI 5.5-12.0]). In new users of bisphosphonates, the risk of hypocalcemia was low across all eGFR groups. Conclusions: In the largest population-based cohort of denosumab users with CKD to date, we found a modest increase in the risk of hypocalcemia with denosumab in those with stage 4 and 5 CKD. These rates are lower than reported in smaller cohort studies. This study was limited by the low numbers of patients with end stage renal disease. Our study emphasizes the importance of awareness of denosumab-induced hypocalcemia, routine monitoring post-denosumab, and benefit-risk assessment before prescribing this treatment to patients with kidney disease. Funding: Private Foundation Support, Government Support - Non-U.S.The cumulative incidence of mild hypocalcemia (Ca <2.00 mmol/L) at 180 days
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".