麻豆传媒

AUSTIN, Texas -- Hypocalcemia was common among end-stage renal disease (ESRD) patients treated with denosumab, according to a meta-analysis reported here.

Led by Prakrati C. Acharya, MBBS, of the University of Mississippi Medical Center, the analysis found an incidence of denosumab-associated hypocalcemia was 42% (95% CI 29% to 55%) among the 84 patients included in the final analysis.

Although there were significant increases reported in bone mineral density (BMD) following treatment -- particularly in the lumbar spine (mean difference 0.39, 95% CI 0.10-0.69, P=0.01) and femoral neck (MD 0.79, 95% CI 0.60-0.98, P<0.01) -- this coincided with a significant drop in parathyroid hormone levels (standardized MD -1.89, 95% CI -3.44 to 0.34, P=0.02).

Presented at the , Acharya told 麻豆传媒 that these findings point to "the potential efficacy of denosumab in the improvement in BMD among ESRD patients on dialysis," despite the high incidence of denosumab-associated hypocalcemia in these patients.

The study found no significant changes in regards to serum phosphate levels (MD -0.10 mg/dL, 95% CI -0.70 to 0.49 mg/dL, P=0.74), and there were no changes in serum calcium levels when calcium and vitamin D supplements were used (MD 0.20 mg/dL, 95% CI -0.30 to 0.69 mg/dL, P=0.44).

"With careful monitoring and appropriate adjustment in calcium dialysate, adequate calcium and active vitamin supplementation, symptomatic hypocalcemia is potentially preventable in ESRD patients treated with denosumab," Acharya noted, but added that this would require further investigation through randomized controlled trials given the lack of evidence in fracture rate improvement with interventions to increase BMD in these patients.

Their current analysis included six observational studies, found from a literature search of the Medline, Embase and Cochrane databases. Acharya explained how her group initially wished to conduct this study to assess both the safety and efficacy of denosumab treatment in patients with ESRD.

"Approximately 2.1 million osteoporosis-related bone fractures are reported each year in the U.S., resulting in as much as $20.3 billion annual direct health costs," she highlighted. "In ESRD patients, the prevalence of osteoporosis ranges from 13% up to 80% and hip fracture rates are 4- to 17-fold higher than in the general population."

Providers must look to options beyond the typically prescribed bisphosphonate treatment for osteoporosis due to current FDA recommendations advising against their use in dialysis patients, as these agents are removed through dialysis.

"This makes it a definite need to look into newer agents," explained Acharya.

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