Abstract
This study investigated whether or not vitamin D and calcium supplementation affected bone metabolism and bone mineral density (BMD) over a period of four years of denosumab therapy in patients with primary osteoporosis. Patients were divided into a denosumab monotherapy group (22 cases) or a denosumab plus vitamin D and calcium supplementation group (combination group, 21 cases). We measured serum bone alkaline phosphatase (BAP), tartrate-resistant acid phosphatase (TRACP)-5b, urinary N-terminal telopeptide of type-I collagen (NTX), and BMD of the lumbar 1–4 vertebrae (L-BMD) and bilateral hips (H-BMD) at baseline and at 12, 24, 36, and 48 months of treatment. There were no significant differences in patient background. Serum BAP, TRACP-5b, and urinary NTX were significantly and comparably inhibited in both groups from 12 to 48 months versus baseline values. L-BMD was significantly increased at every time point in both groups, while H-BMD was significantly increased at every time point in the combination group only. There were significant differences between the groups for L-BMD at 24, 36, and 48 months (P < 0.05) and for H-BMD at 12 months (P < 0.05). Compared with denosumab monotherapy, combination therapy of denosumab plus vitamin D and calcium significantly increased H-BMD at 12 months and L-BMD from 24 to 48 months. These findings indicate that continuous vitamin D and calcium supplementation is important, especially for 12 months to improve H-BMD and from 24 to 48 months to improve L-BMD.
Highlights
Osteoporosis is the most common bone disease and affects millions of people worldwide, the elderly and post-menopausal women
These findings indicate that continuous vitamin D and calcium supplementation is important, especially for 12 months to improve H-bone mineral density (BMD) and from 24 to 48 months to improve L-BMD
There were no significant differences in patient background between the denosumab monotherapy group and combination group (Table 1)
Summary
Osteoporosis is the most common bone disease and affects millions of people worldwide, the elderly and post-menopausal women. Appropriate lifestyle, nutritional supplement, and pharmacological therapeutic choices are required. Medical Guidelines for Practice very recently declared alendronate, risedronate, zoledronic acid, and denosumab as suitable initial therapies for most osteoporosis patients, especially those at high risk of fracture [1]. Denosumab is a fully human monoclonal antibody against receptor activator of nuclear factor-kappa B ligand (RANKL) that has been shown to selectively inhibit osteoclastogenesis. Denosumab abrogates bone resorption, increases bone mineral density (BMD), and prevents fragility fractures [2,3]. We and others have reported that the drug is a good therapeutic option for primary as well as secondary osteoporosis and fracture prevention in young and elderly
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