Efficacy and Safety of Denosumab for the Treatment of Osteoporosis in Patients with Chronic Kidney Disease

Suzuki, Hitoshi; Kihara, Masao; Mano, Satoshi; Kobayashi, Takashi; Kanaguchi, Yasuhiko; Hidaka, Teruo; Gohda, Tomohito; Suzuki, Yusuke

doi:10.21767/2472-5056.100030

Cited by 4 publications

(4 citation statements)

References 23 publications

(27 reference statements)

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“…Unfortunately, our study revealed that treatment with denosumab for a mean of 19.135±16.218 months duration in HD patients with osteoporosis was not associated with an increase in the BMD of the spine, and hope that serum ALP levels decreased in HD patients after treatment with denosumab but was no statistically significant difference when compared with before treatment. Our results regarding BMD are not in agreement with many previous studies as Hiramatsu et al (21) and Suzuki et al (22) revealed that denosumab is an applicable treatment for osteoporosis in patients with CKD. The explanation of our negative results regarding the efficacy of denosumab treatment for osteoporosis is that all our studied patients were on HD and regular HD may affect the pharmacokinetics and pharmacodynamics of denosumab.…”

Section: Discussioncontrasting

confidence: 99%

“…A dose of 1.0 to 1.5 μg/day of vitamin D was required to keep serum calcium during treatment with denosumab and monitoring of serum calcium is important. Our results regarding the adverse effect of denosumab treatment are in agreement with the study of Hiramatsu et al (21), Suzuki et al (22), and Ullah et al (23) who revealed hypocalcemia was a common complication of denosumab treatment particularly in HD patients. the administration of denosumab in patients with high bone turnover creates a situation similar to "hungry bone syndrome (24) leading to a sudden influx of calcium into the bone necessary for bone mineralization and remodeling.…”

Section: Discussionsupporting

confidence: 93%

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Assessment the efficacy and safety of denosumab use for treatment of osteoporosis in hemodialysis patients

et al. 2022

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Introduction: Osteoporosis is common in patients with chronic kidney disease (CKD) that could direct to metabolic abnormalities and accelerate bone loss. The administration of bisphosphonates for the management of osteoporosis is contraindicated in cases with severe kidney impairment. Objectives: In the current investigation, we assess the effectiveness and safety of denosumab administration for the therapy of osteoporosis in hemodialysis (HD) individuals. Patients and Methods: Seventy-four HD cases with osteoporosis who were received denosumab were assessed retrospectively. All individuals received supplemental vitamin D. Serum calcium, phosphate, parathyroid hormone (PTH), and alkaline phosphatase (ALP) had been measured every three months. Denosumab efficacy was measured by assessing the alterations of bone mineral density (BMD) and plasma ALP. Results: The mean values of T-score of the spine and hips in HD patients after treatment with denosumab when compared with before treatment was not statistically significant (P=0.7019 and P=0.494 respectively). There was a low mean serum ALP in the HD patients after treatment with denosumab when compared with before treatment, but not statistically significant (P=0.0625). Plasma calcium concentration decreased shortly after the injection of denosumab however returned within fourteen days. Supplementary vitamin D (1.0 to 1.5 μg/day) looked to prevent hypocalcemia and support long treatment with denosumab. Conclusion: Our study suggests that denosumab is not associated with increases in the BMD of the spine and hip in patients with CKD on HD and hypocalcemia is a concern complication.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionsupporting

confidence: 93%

Assessment the efficacy and safety of denosumab use for treatment of osteoporosis in hemodialysis patients

et al. 2022

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“…Therefore, routine monitoring of kidney function is advised particularly among patients who are concurrently using other medications that impact kidney function [34][35][36][37] . The pharmacokinetics and pharmacodynamics of denosumab used at the standard dose, are unaffected by the presence of renal impairment 38 . In fact, among patients with chronic kidney disease, denosumab provides greater bone mineral density (BMD) gains than bisphosphonates, although vitamin D supplementation is required to prevent hypocalcemia among denosumab users in this population 38 .…”

Section: Discussionmentioning

confidence: 99%

“…The pharmacokinetics and pharmacodynamics of denosumab used at the standard dose, are unaffected by the presence of renal impairment 38 . In fact, among patients with chronic kidney disease, denosumab provides greater bone mineral density (BMD) gains than bisphosphonates, although vitamin D supplementation is required to prevent hypocalcemia among denosumab users in this population 38 . Impaired renal function, which becomes more common with advancing age, increases the risk of progressive bone loss and osteoporosis.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of denosumab for high-risk postmenopausal women with osteoporosis in Thailand

Pongchaiyakul

Nanagara

Songpatanasilp

et al. 2020

Journal of Medical Economics

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Aims: This study assessed the cost-effectiveness of denosumab for treating postmenopausal women with osteoporosis (PMO) at high risk of fracture in Thailand. Materials and methods: A published Markov cohort cost-effectiveness model was populated with country-specific data as available and other published data as needed. The model used a societal perspective, lifetime horizon, efficacy data from network meta-analysis of trials, and included costs for direct medical and non-medical care, informal care, and osteoporosis treatments to compare denosumab to no pharmacologic treatment (calcium and vitamin D supplements only) and to oral weekly alendronate. The base case (high-risk population) included postmenopausal women with femoral neck T-score À2.5, mean age 65 years at entry, and history of vertebral fracture. Results: High-risk women with osteoporosis using denosumab had the greatest number of life years and quality-adjusted life-years (QALYs) with higher reductions in hip and vertebral fracture incidence compared with patients with no pharmacologic treatment. The incremental cost-effectiveness ratio (ICER) was 119,575 Thai Baht (THB) per QALY for denosumab versus no pharmacologic treatment and 199,186 THB per QALY for denosumab versus alendronate. Among Thai postmenopausal women with high-risk of fractures, denosumab was cost-effective compared with no pharmacologic treatment at a willingness-to-pay threshold of 160,000 THB per QALY. One-way sensitivity analysis showed models were most sensitive to changes in denosumab pricing. Limitations: Data from other countries used when country-specific data were unavailable may not accurately reflect the true experience in Thailand. The model focused explicitly on hip, vertebral, and wrist fractures, and therefore provides a conservative estimate of the overall potential impact of osteoporosis-related fracture. The fracture risk was not adjusted to reflect potential changes in risk after denosumab treatment discontinuation. Conclusions: In Thailand, denosumab offers a cost-effective osteoporosis treatment option versus no pharmacologic treatment in postmenopausal women at high risk of fracture.

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Comparison of the clinical effectiveness and safety between the use of denosumab vs bisphosphonates in renal transplant patients

et al. 2020

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Efficacy and Safety of Denosumab for the Treatment of Osteoporosis in Patients with Chronic Kidney Disease

Cited by 4 publications

References 23 publications

Assessment the efficacy and safety of denosumab use for treatment of osteoporosis in hemodialysis patients

Assessment the efficacy and safety of denosumab use for treatment of osteoporosis in hemodialysis patients

Cost-effectiveness of denosumab for high-risk postmenopausal women with osteoporosis in Thailand

Comparison of the clinical effectiveness and safety between the use of denosumab vs bisphosphonates in renal transplant patients

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