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
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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