The DOI matches its Crossref record; 7 of the 7 references it cites were found in a registry or an index.
Efficacy of Bazedoxifene in Reducing New Vertebral Fracture Risk in Postmenopausal Women With Osteoporosis: Results From a 3-Year, Randomized, Placebo-, and Active-Controlled Clinical Trial
Abstract
In this 3-yr, randomized, double-blind, placebo- and active-controlled study, healthy postmenopausal women with osteoporosis (55–85 yr of age) were treated with bazedoxifene 20 or 40 mg/d, raloxifene 60 mg/d, or placebo. The primary endpoint was incidence of new vertebral fractures after 36 mo; secondary endpoints included nonvertebral fractures, BMD, and bone turnover markers. Among 6847 subjects in the intent-to-treat population, the incidence of new vertebral fractures was significantly lower (p < 0.05) with bazedoxifene 20 mg (2.3%), bazedoxifene 40 mg (2.5%), and raloxifene 60 mg (2.3%) compared with placebo (4.1%), with relative risk reductions of 42%, 37%, and 42%, respectively. The treatment effect was similar among subjects with or without prevalent vertebral fracture (p = 0.89 for treatment by baseline fracture status interaction). The incidence of nonvertebral fractures with bazedoxifene or raloxifene was not significantly different from placebo. In a posthoc analysis of a subgroup of women at higher fracture risk (femoral neck T-score ≤ –3.0 and/or ≥1 moderate or severe vertebral fracture or multiple mild vertebral fractures; n = 1772), bazedoxifene 20 mg showed a 50% and 44% reduction in nonvertebral fracture risk relative to placebo (p = 0.02) and raloxifene 60 mg (p = 0.05), respectively. Bazedoxifene significantly improved BMD and reduced bone marker levels (p < 0.001 versus placebo). The incidence of vasodilatation, leg cramps, and venous thromboembolic events was higher with bazedoxifene and raloxifene compared with placebo. In conclusion, bazedoxifene significantly reduced the risk of new vertebral fracture in postmenopausal women with osteoporosis and decreased the risk of nonvertebral fracture in subjects at higher fracture risk.
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Citations
Cites
Incidence and Economic Burden of Osteoporosis-Related Fractures in the United States, 2005–2025
Burge, R., Dawson-Hughes, B., Solomon, D. H., Wong, J. B., King, A., & Tosteson, A. (2007) · Journal of Bone and Mineral Research · doi:10.1359/jbmr.061113 · Cited by 4,026
Effect of Risedronate on the Risk of Hip Fracture in Elderly Women
McClung, M. R., Geusens, P., Miller, P. D., Zippel, H., Bensen, W. G., Roux, C., Adami, S., Fogelman, I., Diamond, T., Eastell, R., et al. (2001) · New England Journal of Medicine · doi:10.1056/nejm200102013440503 · Cited by 1,918
Sex Steroids and the Construction and Conservation of the Adult Skeleton
Riggs, B. L., Khosla, S., & Melton, L. J. (2002) · Endocrine Reviews · doi:10.1210/edrv.23.3.0465 · Cited by 1,846
Chesnut, C. H., Skag, A., Christiansen, C., Recker, R., Stakkestad, J. A., Hoiseth, A., Felsenberg, D., Huss, H., Gilbride, J., Schimmer, R. C., et al. (2004) · Journal of Bone and Mineral Research · doi:10.1359/jbmr.040325 · Cited by 1,229
Self-citationEstrogen deficiency and bone loss: an inflammatory tale
Weitzmann, M. N. (2006) · Journal of Clinical Investigation · doi:10.1172/jci28550 · Cited by 990
Cummings, S. R., Karpf, D. B., Harris, F., Genant, H. K., Ensrud, K., LaCroix, A. Z., & Black, D. M. (2002) · The American Journal of Medicine · doi:10.1016/s0002-9343(01)01124-x · Cited by 752
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Compston, J. E., McClung, M. R., & Leslie, W. D. (2019) · The Lancet · doi:10.1016/s0140-6736(18)32112-3 · Cited by 2,449
European guidance for the diagnosis and management of osteoporosis in postmenopausal women
on behalf of the Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis (ESCEO) and the Committees of Scientific Advisors and National Societies of the International Osteoporosis Foundation (IOF), Kanis, J. A., Cooper, C., Rizzoli, R., & Reginster, J.-Y. (2019) · Osteoporosis International · doi:10.1007/s00198-018-4704-5 · Cited by 1,900
Camacho, P. M., Petak, S. M., Binkley, N., Diab, D. L., Eldeiry, L. S., Farooki, A., Harris, S. T., Hurley, D. L., Kelly, J., Lewiecki, E. M., et al. (2020) · Endocrine Practice · doi:10.4158/gl-2020-0524suppl · Cited by 1,182
Camacho, P. M., Petak, S. M., Binkley, N., Clarke, B. L., Harris, S. T., Hurley, D. L., Kleerekoper, M., Lewiecki, E. M., Miller, P. D., Narula, H. S., et al. (2016) · Endocrine Practice · doi:10.4158/ep161435.esgl · Cited by 1,140
Estrogens and androgens in skeletal physiology and pathophysiology
Almeida, M., Laurent, M. R., Dubois, V., Claessens, F., O'Brien, C. A., Bouillon, R., Vanderschueren, D., & Manolagas, S. C. (2017) · Physiological Reviews · doi:10.1152/physrev.00033.2015 · Cited by 860
Metadata
- Authors
- Silverman, S. L., Christiansen, C., Genant, H. K., Vukicevic, S., Zanchetta, J. R., de Villiers, T. J., Constantine, G. D., & Chines, A. A.
- Venue
- Journal of Bone and Mineral Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2008-12-01
- Volume
- 23
- Issue
- 12
- Pages
- 1923-1934
- ISSN
- 0884-0431 (ISSN-L)
- 1523-4681
- OpenAlex
- W1976389084
- Cited by
- 508
- References
- 7
- FWCI
- 35.80
- Type
- journal article
- Language
- en
- Open access
- closed
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