Effect of Denosumab on Bone Mineral Density and Markers of Bone Turnover among Postmenopausal Women with Osteoporosis.

The aim of this study was to evaluate the effect of denosumab (Dmab) on bone mineral density (BMD) and bone turnover markers after 1 year of treatment. Additionally, the effect of Dmab in bisphosphonate-naïve patients (BP-naïve) compared to patients previously treated with bisphosphonates (BP-prior) was analyzed. This retrospective study included 425 postmenopausal women treated with Dmab for 1 year in clinical practice conditions in specialized centers from Argentina. Participants were also divided according to previous bisphosphonate treatment into BP-naïve and BP-prior. A control group of patients treated with BP not switched to Dmab matched by sex, age, and body mass index was used. Data are expressed as mean ± SEM. After 1 year of treatment with Dmab the bone formation markers total alkaline phosphatase and osteocalcin were significantly decreased (23.36% and 43.97%, resp.), as was the bone resorption marker s-CTX (69.61%). Significant increases in BMD were observed at the lumbar spine, femoral neck, and total hip without differences between BP-naïve and BP-prior. A better BMD response was found in BP-prior group compared with BP treated patients not switched to Dmab. Conclusion. Dmab treatment increased BMD and decreased bone turnover markers in the whole group, with similar response in BP-naïve and BP-prior patients. A better BMD response in BP-prior patients versus BP treated patients not switched to Dmab was observed.

[Effects on bone mass of oral alendronate, hormone replacement therapy and combined regimes in post-menopausal women: preliminary report on a comparative study]. / Efectos del alendronato oral, la hormonoterapia de reemplazo y la combinación de ambos sobre la masa ósea en mujeres posmenopáusicas. Informe preliminar de un estudio comparativo.

The results of a prospective study that compared the short term effects on skeletal bone of oral alendronate, transdermal hormone replacement therapy (HRT) and two combined regimens with both medications are reported. Ninety six posmenopausal women with osteopenia (WHO classification) in lumbar spine or femoral neck measured by DEXA (table 1) were included in 4 therapeutic groups: Group I (n:19): 17 beta-Estradiol 50 micrograms daily transdermally/medroxiprogesterone 2.5 mg orally per day; Group II (n:42): alendronate 10 mg/day orally; Group III (n:15): HRT + alendronate 10 mg/day and Group IV (n:20): HTR + alendronate 5 mg/day. After 12 month treatment, lumbar bone mineral density (BMD) significantly increased to 3.6%; 4.1%; 6.5% y 3.1% in group I to IV, respectively (p < 0.01; figure 1). Differences among groups do not reached statistical significance. The percentage of responders to medication in each group was of 68.8%; 92%; 90% y 83%, respectively. Bone mineral density in femoral neck (FN) increased with all regimens, though mean values did not surpass method variation coefficient. Differences from baseline were statistically significant in group I (p < 0.05). The percentage of responders in this region was 58.8%; 60%; 62.5% y 45.5%, respectively. Biochemical bone markers (table 2), especially urinary pyridinoline and serum osteocalcin, showed a trend in bone metabolism inhibition that was more sustained in group III, as show mainly by the bone markers pyridinolines and osteocalcin. It is concluded that either single therapy with alendronate or estrogen or their combination halted bone loss in most patients leading to bone mass gain mainly in lumbar spine in the short term. However, bone effects with hormone replacement therapy in association with alendronate 10 mg were comparatively major, indicating the potential benefits of this regimen in the long term.