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
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
29129436
DOI
10.1016/s0140-6736(17)32137-2
PII: S0140-6736(17)32137-2
Knihovny.cz E-zdroje
- MeSH
- dvojitá slepá metoda MeSH
- incidence MeSH
- inhibitory kostní resorpce škodlivé účinky terapeutické užití MeSH
- kostní denzita účinky léků MeSH
- kyselina risedronová škodlivé účinky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- osteoporotické fraktury diagnostické zobrazování etiologie patofyziologie prevence a kontrola MeSH
- postmenopauzální osteoporóza komplikace farmakoterapie epidemiologie patofyziologie MeSH
- radiografie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- teriparatid škodlivé účinky terapeutické užití MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Amerika epidemiologie MeSH
- Evropa epidemiologie MeSH
- Názvy látek
- inhibitory kostní resorpce MeSH
- kyselina risedronová MeSH
- teriparatid MeSH
BACKGROUND: 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. METHODS: 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). FINDINGS: 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). INTERPRETATION: 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. FUNDING: Lilly.
CCBR Brasil Centro de Analises e Pesquisas Clinicas Rio de Janeiro Brazil
Centro de Osteopatías Comlit Buenos Aires Argentina
Centro Paulista de Investigaçao Clínica São Paulo Brazil
CHU Brugmann ULB Brussels Belgium
Department of Internal Medicine General University Hospital Prague Czech Republic
Division of Endocrinology and Metabolism Medical University of Graz Graz Austria
Hospital Sant Pau Barcelona Spain
Institut Präventive Medizin and Klinische Forschung Magdeburg Germany
Lilly Research Center Madrid Spain
Maastricht University Medical Center Maastricht Netherlands
Osteoporosis Center University of Pittsburgh Pittsburgh PA USA
Policlinico Umberto 1 Rome Italy
Semmelweis University Medical School Budapest Hungary
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT01709110
