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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.
Lancet. 2018 01 20; 391(10117):230-240.Lct

Abstract

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.

Authors+Show Affiliations

University of British Columbia, Vancouver, Canada. Electronic address: davidkendler@gmail.com.Lilly Research Center, Madrid, Spain.Centro Paulista de Investigaçao Clínica, São Paulo, Brazil.CCBR Brasil Centro de Analises e Pesquisas Clinicas, Rio de Janeiro, Brazil.Osteoporosis Center, University of Pittsburgh, Pittsburgh, PA, USA.Department of Internal Medicine, General University Hospital, Prague, Czech Republic.Centro de Osteopatías Comlit, Buenos Aires, Argentina.Hospital Sant Pau, Barcelona, Spain.Semmelweis University Medical School, Budapest, Hungary.Division of Endocrinology and Metabolism, Medical University of Graz, Graz, Austria.University Orléans, Orléans, France.Policlinico Umberto I, Rome, Italy.CHU Brugmann, ULB, Brussels, Belgium.Maastricht University Medical Center, Maastricht, Netherlands.Institut Präventive Medizin & Klinische Forschung, Magdeburg, Germany.Lilly Research Center, Madrid, Spain.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29129436

Citation

Kendler, David L., et al. "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." Lancet (London, England), vol. 391, no. 10117, 2018, pp. 230-240.
Kendler DL, Marin F, Zerbini CAF, et al. 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. Lancet. 2018;391(10117):230-240.
Kendler, D. L., Marin, F., Zerbini, C. A. F., Russo, L. A., Greenspan, S. L., Zikan, V., Bagur, A., Malouf-Sierra, J., Lakatos, P., Fahrleitner-Pammer, A., Lespessailles, E., Minisola, S., Body, J. J., Geusens, P., Möricke, R., & López-Romero, P. (2018). 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. Lancet (London, England), 391(10117), 230-240. https://doi.org/10.1016/S0140-6736(17)32137-2
Kendler DL, et al. 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. Lancet. 2018 01 20;391(10117):230-240. PubMed PMID: 29129436.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kendler,David L, AU - Marin,Fernando, AU - Zerbini,Cristiano A F, AU - Russo,Luis A, AU - Greenspan,Susan L, AU - Zikan,Vit, AU - Bagur,Alicia, AU - Malouf-Sierra,Jorge, AU - Lakatos,Péter, AU - Fahrleitner-Pammer,Astrid, AU - Lespessailles,Eric, AU - Minisola,Salvatore, AU - Body,Jean Jacques, AU - Geusens,Piet, AU - Möricke,Rüdiger, AU - López-Romero,Pedro, Y1 - 2017/11/09/ PY - 2017/05/05/received PY - 2017/06/28/revised PY - 2017/07/06/accepted PY - 2017/11/14/pubmed PY - 2018/10/16/medline PY - 2017/11/14/entrez SP - 230 EP - 240 JF - Lancet (London, England) JO - Lancet VL - 391 IS - 10117 N2 - 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. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/29129436/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(17)32137-2 DB - PRIME DP - Unbound Medicine ER -