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

Background: Chronic kidney disease (CKD) is an independent risk factor for osteoporosis and may lead to metabolic abnormalities that accelerate bone loss. Bisphosphonates, the most widely used treatment for osteoporosis, are contraindicated in patients with severe renal impairment. In the present study, we assessed whether denosumab is a safe and effective treatment for osteoporosis in patients with CKD.

Methods and Findings: A total of 143 patients with osteoporosis who were treated with denosumab were analyzed retrospectively. Of these patients, 40 had been previously treated with bisphosphonates. All patients received supplemental vitamin D. Effectiveness was assessed by analyzing changes in bone mineral density (BMD) and serum tartrate-resistant acid phosphatase (TRACP)-5b as a marker for serum bone resorption. More than fifty percent of the patients treated with bisphosphonates showed low BMD at the time their therapy was changed to denosumab. Denosumab was associated with a larger increase in both lumbar and femur neck BMD than were bisphosphonates (+4.8% and +5.5%, respectively). Denosumab decreased serum TRACP-5b while increasing BMD (P<0.001), and was well tolerated. Serum calcium levels decreased shortly after the injection of denosumab, but recovered within 14 days. Supplemental vitamin D (0.5 to 1.0 μg/day) appeared to prevent hypocalcemia and to support efficacy of denosumab.

Conclusions: Denosumab increases BMD in the lumbar vertebra and femur neck in patients with CKD. The effect of denosumab on BMD is greater than that of bisphosphonates in these patients.


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

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