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: | Jean-Jacques Body, Salvatore Minisola, Pedro Lopez-Romero, Cristiano A. F. Zerbini, Eric Lespessailles, Peter L. Lakatos, Fernando Marin, Astrid Fahrleitner-Pammer, Ruediger Moricke, Jorge Malouf-Sierra, Alicia Bagur, Piet Geusens, Susan L. Greenspan, Vit Zikan, David L. Kendler, Luis A. Russo |
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Přispěvatelé: | Imagerie Multimodale Multiéchelle et Modélisation du Tissu Osseux et articulaire (I3MTO), Université d'Orléans (UO), RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Interne Geneeskunde |
Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
Abaloparatide
Osteoporosis law.invention 0302 clinical medicine Randomized controlled trial law Bone Density Teriparatide 030212 general & internal medicine ALENDRONATE ComputingMilieux_MISCELLANEOUS Osteoporosis Postmenopausal Aged 80 and over RISK Bone Density Conservation Agents PLACEBO Incidence General Medicine Middle Aged 3. Good health Europe Denosumab [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ZOLEDRONIC ACID Female Risedronic Acid medicine.drug medicine.medical_specialty VERTEBRAL FRACTURES 030209 endocrinology & metabolism Placebo 03 medical and health sciences Double-Blind Method BMD medicine Humans Aged DENOSUMAB business.industry medicine.disease Surgery Clinical trial Radiography LOW BONE MASS Zoledronic acid Americas business Osteoporotic Fractures |
Zdroj: | LANCET r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau Universitat Pompeu Fabra The Lancet The Lancet, Elsevier, 2018, 391 (10117), pp.230-240. ⟨10.1016/S0140-6736(17)32137-2⟩ Lancet, 391(10117), 230-240. Elsevier Science |
ISSN: | 1474-547X 0140-6736 0923-7577 |
Popis: | 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; p0·0001). 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. |
Databáze: | OpenAIRE |
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