Older women with CKD on denosumab may have a higher risk for hypocalcemia
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Key takeaways:
- Hypocalcemia risk increased with worsening CKD stages, particularly for patients on dialysis.
- Emergently treated hypocalcemia risk was 3.01% for patients on dialysis taking denosumab.
Older women with chronic kidney disease who take denosumab may have a higher risk for emergently treated hypocalcemia compared with those treated with bisphosphonates, according to published data.
“Patients with advanced CKD have an increased risk for hypocalcemia as the kidneys cannot effectively produce activated vitamin D to facilitate absorption of calcium from the gastrointestinal tract,” Steven T. Bird, PhD, PharmD, of the Center for Drug Evaluation and Research, wrote with colleagues.
“Although injectable therapies may be more convenient, they are more potent inhibitors of osteoclast activity and have potential for a greater hypocalcemic effect,” according to the study authors.
They conducted a target trial emulation using Medicare fee-for-service data with prescription drug coverage, from 2012 to 2020, to assess hypocalcemia risk with denosumab by CKD stage and presence of CKD-mineral and bone disorder.
The study included women aged 65 years or older on denosumab, oral bisphosphonates or IV bisphosphonates for osteoporosis. Overall, 361,453 patients were treated with denosumab, 829,044 with oral bisphosphonates and 160,413 with IV bisphosphonates.
Researchers assessed hospital and ED admissions in the first 12 weeks of treatment.
The risk of hypocalcemia increased with worsening CKD stages, particularly for patients on dialysis, according to the results. For dialysis-dependent patients, emergently treated hypocalcemia risk was 3.01% for patients on denosumab and 0% for women on oral bisphosphonates. Meanwhile, non-dialysis-dependent patients with CKD stages 4 and 5 had a 0.57% risk vs. 0.03% for oral bisphosphonates.
For patients with CKD stages 4 and 5, those with CKD-mineral and bone disorder had greater risk when treated with denosumab with rates of 1.53% compared with 0.02% for oral bisphosphonates, data showed.
Patients without CKD-mineral and bone disorder had a risk of 0.22% vs. 0.03% for oral bisphosphonates, the researchers wrote.
“Diagnosis and management of skeletal fragility in these high-risk patients is complex, requiring careful patient selection, adequate supplementation with calcium and vitamin D, and frequent monitoring of serum calcium under supervision of a clinician with expert knowledge and experience treating CKD-mineral and bone disorder,” they wrote.
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