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AEs decreased in severity at the end of study. Thirty-five patients (94.6%) reported injection site reaction (ISR) and two patients (5.3%) reported ISR at a severity of grade 2. AEs were reported in 82.1% of patients and most common were tenderness at injection sites (24.3%) and abnormal blood glucose level (21.1%). The primary endpoint was adverse events (AEs) and secondary endpoints included bone turnover markers, serum calcium, creatinine, and blood glucose. A prospective, open-label, multi-centre study was conducted in 38 osteoporotic Japanese women.
To evaluate the safety, tolerability and efficacy of a novel subcutaneous (s.c.) injection of denosumab in Japanese postmenopausal women with osteoporosis. fox.Open-label, multi-centre study of the tolerability of a novel denosumab subcutaneous injection in Japanese postmenopausal women with osteoporosis.
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