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The effect of 6 versus 9 years of zoledronic acid treatment in osteoporosis: a randomized second extension to the HORIZON-Pivotal Fracture Trial (PFT).
J Bone Miner Res. 2015 May; 30(5):934-44.JB

Abstract

While bisphosphonates reduce fracture risk over 3 to 5 years, the optimal duration of treatment is uncertain. In a randomized extension study (E1) of the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial (HORIZON-PFT), zoledronic acid (ZOL) 5 mg annually for 6 years showed maintenance of bone mineral density (BMD), decrease in morphometric vertebral fractures, and a modest reduction in bone turnover markers (BTMs) compared with discontinuation after 3 years. To investigate the longer-term efficacy and safety of ZOL, a second extension (E2) was conducted to 9 years in which women on ZOL for 6 years in E1 were randomized to either ZOL (Z9) or placebo (Z6P3) for 3 additional years. In this multicenter, randomized, double-blind study, 190 women were randomized to Z9 (n = 95) and Z6P3 (n = 95). The primary endpoint was change in total hip BMD at year 9 vs. year 6 in Z9 compared with Z6P3. Other secondary endpoints included fractures, BTMs, and safety. From year 6 to 9, the mean change in total hip BMD was -0.54% in Z9 vs. -1.31% in Z6P3 (difference 0.78%; 95% confidence interval [CI]: -0.37%, 1.93%; p = 0.183). BTMs showed small, non-significant increases in those who discontinued after 6 years compared with those who continued for 9 years. The number of fractures was low and did not significantly differ by treatment. While generally safe, there was a small increase in cardiac arrhythmias (combined serious and non-serious) in the Z9 group but no significant imbalance in other safety parameters. The results suggest almost all patients who have received six annual ZOL infusions can stop medication for up to 3 years with apparent maintenance of benefits.

Authors+Show Affiliations

University of California, San Francisco, CA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

25545380

Citation

Black, Dennis M., et al. "The Effect of 6 Versus 9 Years of Zoledronic Acid Treatment in Osteoporosis: a Randomized Second Extension to the HORIZON-Pivotal Fracture Trial (PFT)." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 30, no. 5, 2015, pp. 934-44.
Black DM, Reid IR, Cauley JA, et al. The effect of 6 versus 9 years of zoledronic acid treatment in osteoporosis: a randomized second extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2015;30(5):934-44.
Black, D. M., Reid, I. R., Cauley, J. A., Cosman, F., Leung, P. C., Lakatos, P., Lippuner, K., Cummings, S. R., Hue, T. F., Mukhopadhyay, A., Tan, M., Aftring, R. P., & Eastell, R. (2015). The effect of 6 versus 9 years of zoledronic acid treatment in osteoporosis: a randomized second extension to the HORIZON-Pivotal Fracture Trial (PFT). Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 30(5), 934-44. https://doi.org/10.1002/jbmr.2442
Black DM, et al. The Effect of 6 Versus 9 Years of Zoledronic Acid Treatment in Osteoporosis: a Randomized Second Extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2015;30(5):934-44. PubMed PMID: 25545380.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of 6 versus 9 years of zoledronic acid treatment in osteoporosis: a randomized second extension to the HORIZON-Pivotal Fracture Trial (PFT). AU - Black,Dennis M, AU - Reid,Ian R, AU - Cauley,Jane A, AU - Cosman,Felicia, AU - Leung,Ping Chung, AU - Lakatos,Peter, AU - Lippuner,Kurt, AU - Cummings,Steven R, AU - Hue,Trisha F, AU - Mukhopadhyay,Amitava, AU - Tan,Monique, AU - Aftring,R Paul, AU - Eastell,Richard, PY - 2014/09/09/received PY - 2014/12/08/revised PY - 2014/12/26/accepted PY - 2014/12/30/entrez PY - 2014/12/30/pubmed PY - 2016/3/15/medline KW - ANTIRESORPTIVES KW - BIOCHEMICAL MARKERS OF BONE TURNOVER KW - FRACTURE PREVENTION KW - OSTEOPOROSIS KW - RANDOMIZED CLINICAL TRIALS SP - 934 EP - 44 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J Bone Miner Res VL - 30 IS - 5 N2 - While bisphosphonates reduce fracture risk over 3 to 5 years, the optimal duration of treatment is uncertain. In a randomized extension study (E1) of the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial (HORIZON-PFT), zoledronic acid (ZOL) 5 mg annually for 6 years showed maintenance of bone mineral density (BMD), decrease in morphometric vertebral fractures, and a modest reduction in bone turnover markers (BTMs) compared with discontinuation after 3 years. To investigate the longer-term efficacy and safety of ZOL, a second extension (E2) was conducted to 9 years in which women on ZOL for 6 years in E1 were randomized to either ZOL (Z9) or placebo (Z6P3) for 3 additional years. In this multicenter, randomized, double-blind study, 190 women were randomized to Z9 (n = 95) and Z6P3 (n = 95). The primary endpoint was change in total hip BMD at year 9 vs. year 6 in Z9 compared with Z6P3. Other secondary endpoints included fractures, BTMs, and safety. From year 6 to 9, the mean change in total hip BMD was -0.54% in Z9 vs. -1.31% in Z6P3 (difference 0.78%; 95% confidence interval [CI]: -0.37%, 1.93%; p = 0.183). BTMs showed small, non-significant increases in those who discontinued after 6 years compared with those who continued for 9 years. The number of fractures was low and did not significantly differ by treatment. While generally safe, there was a small increase in cardiac arrhythmias (combined serious and non-serious) in the Z9 group but no significant imbalance in other safety parameters. The results suggest almost all patients who have received six annual ZOL infusions can stop medication for up to 3 years with apparent maintenance of benefits. SN - 1523-4681 UR - https://www.unboundmedicine.com/medline/citation/25545380/The_effect_of_6_versus_9_years_of_zoledronic_acid_treatment_in_osteoporosis:_a_randomized_second_extension_to_the_HORIZON_Pivotal_Fracture_Trial__PFT__ L2 - https://doi.org/10.1002/jbmr.2442 DB - PRIME DP - Unbound Medicine ER -