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Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial

Kendler, David L ; Marin, Fernando ; Zerbini, Cristiano A F ; Russo, Luis A ; Greenspan, Susan L ; Zikan, Vit ; Bagur, Alicia ; Malouf-Sierra, Jorge ; Lakatos, Péter ; Fahrleitner-Pammer, Astrid ; Lespessailles, Eric ; Minisola, Salvatore ; Body, Jean Jacques ; Geusens, Piet ; Möricke, Rüdiger ; López-Romero, Pedro

The Lancet (British edition), 2018-01, Vol.391 (10117), p.230-240 [Periódico revisado por pares]

England: Elsevier Ltd

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Título:
Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial
Autor: Kendler, David L ; Marin, Fernando ; Zerbini, Cristiano A F ; Russo, Luis A ; Greenspan, Susan L ; Zikan, Vit ; Bagur, Alicia ; Malouf-Sierra, Jorge ; Lakatos, Péter ; Fahrleitner-Pammer, Astrid ; Lespessailles, Eric ; Minisola, Salvatore ; Body, Jean Jacques ; Geusens, Piet ; Möricke, Rüdiger ; López-Romero, Pedro
Assuntos: Aged ; Aged, 80 and over ; Americas - epidemiology ; Biocompatibility ; Bisphosphonates ; Bone density ; Bone Density - drug effects ; Bone Density Conservation Agents - adverse effects ; Bone Density Conservation Agents - therapeutic use ; Clinical trials ; Double-Blind Method ; Drug dosages ; Drug therapy ; Europe - epidemiology ; Evidence-based medicine ; Female ; Fractures ; Human health and pathology ; Humans ; Incidence ; Life Sciences ; Middle Aged ; Monoclonal antibodies ; Osteoporosis ; Osteoporosis, Postmenopausal - complications ; Osteoporosis, Postmenopausal - drug therapy ; Osteoporosis, Postmenopausal - epidemiology ; Osteoporosis, Postmenopausal - physiopathology ; Osteoporotic Fractures - diagnostic imaging ; Osteoporotic Fractures - etiology ; Osteoporotic Fractures - physiopathology ; Osteoporotic Fractures - prevention & control ; Parathyroid hormone ; Patients ; Radiography ; Rhumatology and musculoskeletal system ; Risedronic acid ; Risedronic Acid - adverse effects ; Risedronic Acid - therapeutic use ; Teriparatide - adverse effects ; Teriparatide - therapeutic use ; Vitamin D ; Womens health
É parte de: The Lancet (British edition), 2018-01, Vol.391 (10117), p.230-240
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-News-2
ObjectType-Feature-3
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Descrição: No clinical trials have compared osteoporosis drugs with incident fractures as the primary outcome. We compared the anti-fracture efficacy of teriparatide with risedronate in patients with severe osteoporosis. In this double-blind, double-dummy trial, we enrolled post-menopausal women with at least two moderate or one severe vertebral fracture and a bone mineral density T score of less than or equal to −1·50. Participants were randomly assigned to receive 20 μg of teriparatide once daily plus oral weekly placebo or 35 mg of oral risedronate once weekly plus daily injections of placebo for 24 months. The primary outcome was new radiographic vertebral fractures. Secondary, gated outcomes included new and worsened radiographic vertebral fractures, clinical fractures (a composite of non-vertebral and symptomatic vertebral), and non-vertebral fractures. This study is registered with ClinicalTrials.gov (NCT01709110) and EudraCT (2012-000123-41). We enrolled 680 patients in each group. At 24 months, new vertebral fractures occurred in 28 (5·4%) of 680 patients in the teriparatide group and 64 (12·0%) of 680 patients in the risedronate group (risk ratio 0·44, 95% CI 0·29–0·68; p<0·0001). Clinical fractures occurred in 30 (4·8%) of 680 patients in the teriparatide group compared with 61 (9·8%) of 680 in the risedronate group (hazard ratio 0·48, 95% CI 0·32–0·74; p=0·0009). Non-vertebral fragility fractures occurred in 25 (4·0%) patients in the teriparatide group and 38 (6·1%) in the risedronate group (hazard ratio 0·66; 95% CI 0·39–1·10; p=0·10). Among post-menopausal women with severe osteoporosis, the risk of new vertebral and clinical fractures is significantly lower in patients receiving teriparatide than in those receiving risedronate. Lilly.
Editor: England: Elsevier Ltd
Idioma: Inglês

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Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial

England: Elsevier Ltd

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