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The effect of 3 versus 6 years of Zoledronic acid treatment of osteoporosis: A randomized extension to the HORIZON-Pivotal Fracture Trial (PFT)
Open accessAbstract
Zoledronic acid 5 mg (ZOL) annually for 3 years reduces fracture risk in postmenopausal women with osteoporosis. To investigate long-term effects of ZOL on bone mineral density (BMD) and fracture risk, the Health Outcomes and Reduced Incidence with Zoledronic acid Once Yearly–Pivotal Fracture Trial (HORIZON-PFT) was extended to 6 years. In this international, multicenter, double-blind, placebo-controlled extension trial, 1233 postmenopausal women who received ZOL for 3 years in the core study were randomized to 3 additional years of ZOL (Z6, n = 616) or placebo (Z3P3, n = 617). The primary endpoint was femoral neck (FN) BMD percentage change from year 3 to 6 in the intent-to-treat (ITT) population. Secondary endpoints included other BMD sites, fractures, biochemical bone turnover markers, and safety. In years 3 to 6, FN-BMD remained constant in Z6 and dropped slightly in Z3P3 (between-treatment difference = 1.04%; 95% confidence interval 0.4 to 1.7; p = 0.0009) but remained above pretreatment levels. Other BMD sites showed similar differences. Biochemical markers remained constant in Z6 but rose slightly in Z3P3, remaining well below pretreatment levels in both. New morphometric vertebral fractures were lower in the Z6 (n = 14) versus Z3P3 (n = 30) group (odds ratio = 0.51; p = 0.035), whereas other fractures were not different. Significantly more Z6 patients had a transient increase in serum creatinine >0.5 mg/dL (0.65% versus 2.94% in Z3P3). Nonsignificant increases in Z6 of atrial fibrillation serious adverse events (2.0% versus 1.1% in Z3P3; p = 0.26) and stroke (3.1% versus 1.5% in Z3P3; p = 0.06) were seen. Postdose symptoms were similar in both groups. Reports of hypertension were significantly lower in Z6 versus Z3P3 (7.8% versus 15.1%, p < 0.001). Small differences in bone density and markers in those who continued versus those who stopped treatment suggest residual effects, and therefore, after 3 years of annual ZOL, many patients may discontinue therapy up to 3 years. However, vertebral fracture reductions suggest that those at high fracture risk, particularly vertebral fracture, may benefit by continued treatment. (ClinicalTrials.gov identifier: NCT00145327). © 2012 American Society for Bone and Mineral Research
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“Evidence of efficacy beyond 5 years is limited, whereas rare safety concerns such as ONJ and atypical femur fractures become more common beyond 5 years [67, 92].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [92]
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“Evidence of efficacy beyond 5 years is limited, whereas rare safety concerns such as ONJ and atypical femur fractures become more common beyond 5 years [67, 92].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [92]
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Multiple imputation after 18+ years
Rubin, D. B. (1996) · Journal of the American Statistical Association · doi:10.1080/01621459.1996.10476908 · Cited by 4,072
Black, D. M., Cummings, S. R., Karpf, D. B., Cauley, J. A., Thompson, D. E., Nevitt, M. C., Bauer, D. C., Genant, H. K., Haskell, W. L., Marcus, R., et al. (1996) · The Lancet · doi:10.1016/s0140-6736(96)07088-2 · Cited by 3,846
Self-citationOnce-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis
Black, D. M., Delmas, P. D., Eastell, R., Reid, I. R., Boonen, S., Cauley, J. A., Cosman, F., Lakatos, P., Leung, P. C., Man, Z., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa067312 · Cited by 2,986
Self-citationMultiple Imputation After 18+ Years
Rubin, D. B. (1996) · Journal of the American Statistical Association · doi:10.2307/2291635 · Cited by 2,686
Cummings, S. R. (1998) · JAMA · doi:10.1001/jama.280.24.2077 · Cited by 2,277
Self-citationShane, E., Burr, D., Abrahamsen, B., Adler, R. A., Brown, T. D., Cheung, A. M., Cosman, F., Curtis, J. R., Dell, R., Dempster, D. W., et al. (2014) · Journal of Bone and Mineral Research · doi:10.1002/jbmr.1998 · Cited by 2,147
Self-citationZoledronic Acid and Clinical Fractures and Mortality after Hip Fracture
Lyles, K. W., Colón-Emeric, C. S., Magaziner, J. S., Adachi, J. D., Pieper, C. F., Mautalen, C., Hyldstrup, L., Recknor, C., Nordsletten, L., Moore, K. A., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa074941 · Cited by 2,003
Self-citationEffect 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
Self-citationRisk of New Vertebral Fracture in the Year Following a Fracture
Lindsay, R. (2001) · JAMA · doi:10.1001/jama.285.3.320 · Cited by 1,876
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Research works printed but not linked: 2
- Black, 2004, A 5-year randomized trial of the long-term efficacy and safety of alendronate: the FIT Long-term EXtension (FLEX), J Bone Miner Res., 19
- Cosman, 2011, After 3 years of IV zoledronic acid administration, who is at highest risk for subsequent vertebral fractures and who should remain on treatment?, J Bone Miner Res., 26
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Clinician’s Guide to Prevention and Treatment of Osteoporosis
Cosman, F., de Beur, S. J., LeBoff, M. S., Lewiecki, E. M., Tanner, B., Randall, S., & Lindsay, R. (2014) · Osteoporosis International · doi:10.1007/s00198-014-2794-2 · Cited by 4,149
“Evidence of efficacy beyond 5 years is limited, whereas rare safety concerns such as ONJ and atypical femur fractures become more common beyond 5 years [67, 92].”
BackgroundSelf-citationRuggiero, S. L., Dodson, T. B., Fantasia, J. E., Goodday, R. H. B., Aghaloo, T. L., Mehrotra, B., & O’Ryan, F. (2014) · Journal of Oral and Maxillofacial Surgery · doi:10.1016/j.joms.2014.04.031 · Cited by 2,975
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
Black, D. M., & Rosen, C. J. (2016) · New England Journal of Medicine · doi:10.1056/nejmcp1513724 · Cited by 1,790
Self-citationThe clinician's guide to prevention and treatment of osteoporosis
LeBoff, M. S., Greenspan, S. L., Insogna, K. L., Lewiecki, E. M., Saag, K. G., Singer, A. J., & Siris, E. S. (2022) · Osteoporosis International · doi:10.1007/s00198-021-05900-y · Cited by 1,487
Metadata
- Authors
- Black, D. M., Reid, I. R., Boonen, S., Bucci-Rechtweg, C., Cauley, J. A., Cosman, F., Cummings, S. R., Hue, T. F., Lippuner, K., Lakatos, P., Leung, P. C., Man, Z., Martinez, R. L. M., Tan, M., Ruzycky, M. E., Su, G., & Eastell, R.
- Affiliations
- University of California, San Francisco (US)
- University of Auckland (NZ)
- KU Leuven (BE)
- Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
- University of Pittsburgh (US)
- Helen Hayes Hospital (US)
- California Pacific Medical Center (US)
- University Hospital of Bern (CH)
- Semmelweis University (HU)
- Chinese University of Hong Kong (HK)
- Centro Médico TIEMPO, Buenos Aires, Argentina
- University of Sheffield (GB)
- Corresponding author
- Black, Dennis M
- ORCID
- Venue
- Journal of Bone and Mineral Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-12-08
- Volume
- 27
- Issue
- 2
- Pages
- 243-254
- ISSN
- 0884-0431 (ISSN-L)
- 1523-4681
- PMC
- PMC3427916
- OpenAlex
- W2106406207
- Cited by
- 700
- References
- 40
- Citations by year
- 2026: 18 · 2025: 37 · 2024: 29 · 2023: 45 · 2022: 40 · 2021: 58 · 2020: 53 · 2019: 49 · 2018: 48 · 2017: 54 · 2016: 61 · 2015: 62 · 2014: 50 · 2013: 49 · 2012: 35
- FWCI
- 49.40
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Journal of Bone and Mineral Research (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR000005)
- University of California, San Francisco
- Novartis Pharma
- National Center for Research Resources (UL1RR024153)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- zoledronic acid, osteoporosis, postmenopausal women, long-term treatment, bone mineral density, femoral neck, vertebral fractures, fracture risk, bone turnover markers, serum creatinine, atrial fibrillation, stroke, hypertension, bisphosphonates, adverse events
- MeSH terms
- Zoledronic Acid, Aged, Diphosphonates, Female, Follow-Up Studies, Humans, Imidazoles, Osteoporosis, Peptide Fragments, Procollagen, Time Factors, Biomarkers, Bone Density, Incidence, Bone Remodeling, Treatment Outcome, Bone Density Conservation Agents, Osteoporotic Fractures
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