C Beaudoin1,2,3, S Jean4,5, L Bessette6,5, L-G Ste-Marie7, L Moore8, J P Brown6,5. 1. Centre de recherche du CHU de Québec (CHUL), 2705, Boulevard Laurier, Québec, Québec, G1V 4G2, Canada. claudia.beaudoin@crchuq.ulaval.ca. 2. Département de médecine sociale et préventive, Faculté de médecine, Université Laval, Québec, Canada. claudia.beaudoin@crchuq.ulaval.ca. 3. Bureau d'information et d'études en santé des populations, Institut national de santé publique du Québec, Québec, Canada. claudia.beaudoin@crchuq.ulaval.ca. 4. Bureau d'information et d'études en santé des populations, Institut national de santé publique du Québec, Québec, Canada. 5. Département de médecine, Faculté de médecine, Université Laval, Québec, Canada. 6. Centre de recherche du CHU de Québec (CHUL), 2705, Boulevard Laurier, Québec, Québec, G1V 4G2, Canada. 7. Département de médecine, Faculté de médecine, Université de Montréal, Montréal, Canada. 8. Département de médecine sociale et préventive, Faculté de médecine, Université Laval, Québec, Canada.
Abstract
UNLABELLED: The aim of this review is to compare the efficacy and safety of denosumab over other treatments for osteoporosis. The results of this study suggest that the safety of denosumab and its efficacy in reducing fractures is not significantly different from bisphosphonates. Denosumab was, however, more effective in increasing bone mineral density. INTRODUCTION: This study was conducted to compare the efficacy and safety of denosumab over other pharmacological treatments for osteoporosis in individuals at risk of fracture. METHODS: Randomised controlled trials comparing denosumab with another pharmacological treatment for osteoporosis were searched in MEDLINE, EMBASE and CENTRAL. Identified articles were screened by two independent reviewers and assessed for inclusion. Data from included studies were extracted and meta-analyses were conducted using random effects models. RESULTS: Nine studies including a total of 4890 postmenopausal women were identified. The follow-up period varied from 12 to 24 months. In all studies except one, the comparator treatment was a bisphosphonate. There was no statistically significant difference between patients receiving denosumab and those receiving a bisphosphonate in terms of fracture risk (RR[95 % CI] = 1.15 [0.84-1.58]), adverse events (RR[95 % CI] = 0.99 [0.96-1.02]) or deaths (OR[95 % CI] = 0.58 [0.12-2.71]). Withdrawals due to adverse events were less frequent in denosumab than in other treatment groups but the difference did not reach statistical significance (OR[95 % CI] = 0.68 [0.45-1.04]). The percent change in bone mineral density at the total hip, lumbar spine, femoral neck and one-third radius was significantly higher in participants who received denosumab (e.g. mean difference [95 % CI] at the total hip: 1.06 [0.86-1.25]). CONCLUSIONS: These results suggest that, after 12 to 24 months, the safety and efficacy of denosumab for reducing fracture risk is not significantly different from bisphosphonates despite higher gains in bone mineral density. In a clinical setting, denosumab may demonstrate greater effectiveness.
UNLABELLED: The aim of this review is to compare the efficacy and safety of denosumab over other treatments for osteoporosis. The results of this study suggest that the safety of denosumab and its efficacy in reducing fractures is not significantly different from bisphosphonates. Denosumab was, however, more effective in increasing bone mineral density. INTRODUCTION: This study was conducted to compare the efficacy and safety of denosumab over other pharmacological treatments for osteoporosis in individuals at risk of fracture. METHODS: Randomised controlled trials comparing denosumab with another pharmacological treatment for osteoporosis were searched in MEDLINE, EMBASE and CENTRAL. Identified articles were screened by two independent reviewers and assessed for inclusion. Data from included studies were extracted and meta-analyses were conducted using random effects models. RESULTS: Nine studies including a total of 4890 postmenopausal women were identified. The follow-up period varied from 12 to 24 months. In all studies except one, the comparator treatment was a bisphosphonate. There was no statistically significant difference between patients receiving denosumab and those receiving a bisphosphonate in terms of fracture risk (RR[95 % CI] = 1.15 [0.84-1.58]), adverse events (RR[95 % CI] = 0.99 [0.96-1.02]) or deaths (OR[95 % CI] = 0.58 [0.12-2.71]). Withdrawals due to adverse events were less frequent in denosumab than in other treatment groups but the difference did not reach statistical significance (OR[95 % CI] = 0.68 [0.45-1.04]). The percent change in bone mineral density at the total hip, lumbar spine, femoral neck and one-third radius was significantly higher in participants who received denosumab (e.g. mean difference [95 % CI] at the total hip: 1.06 [0.86-1.25]). CONCLUSIONS: These results suggest that, after 12 to 24 months, the safety and efficacy of denosumab for reducing fracture risk is not significantly different from bisphosphonates despite higher gains in bone mineral density. In a clinical setting, denosumab may demonstrate greater effectiveness.
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