Cited by 700Bone health and osteoporosis researchBone health and treatmentsMenopause: Health Impacts and Treatments

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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)

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Black, Dennis M, Reid, Ian R, Boonen, Steven, Bucci-Rechtweg, Christina, Cauley, Jane A, Cosman, Felicia, Cummings, Steven R, Hue, Trisha F, Lippuner, Kurt, Lakatos, Peter, Leung, Ping Chung, Man, Zulema, Martinez, Ruvie Lou Maria, Tan, Monique, Ruzycky, Mary Ellen, Su, Guoqin, Eastell, Richard·2012·Journal of Bone and Mineral Research

DOI 10.1002/jbmr.1494PMC PMC3427916

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Abstract

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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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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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: Black, Dennis M
Reid, Ian R
Bucci-Rechtweg, Christina
Cauley, Jane A
Cosman, Felicia
Cummings, Steven R
Hue, Trisha F
Lippuner, Kurt
Lakatos, Peter
Leung, Ping Chung
Tan, Monique
Eastell, Richard
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
DOI: 10.1002/jbmr.1494
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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The effect of 3 versus 6 years of Zoledronic acid treatment of osteoporosis: A randomized extension to the HORIZON-Pivotal Fracture Trial (PFT)

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