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Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study).
Osteoporos Int. 2017 01; 28(1):389-398.OI

Abstract

In a 2-year randomized, placebo-controlled study of 665 Japanese patients with primary osteoporosis, once-yearly administration of zoledronic acid (5 mg) reduced the risk of new morphometric vertebral fractures.

INTRODUCTION

The purpose of this study was to determine the efficacy and safety of once-yearly intravenous infusion of ZOL in Japanese patients with primary osteoporosis.

METHODS

This was a two-year multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative study (ZONE Study). Subjects were 665 Japanese patients between the ages of 65 and 89 years who had prevalent vertebral fracture. Subjects were randomly assigned to receive once-yearly intravenous infusion of 5 mg of ZOL or placebo at baseline and 12 months.

RESULTS

The 2-year incidence of new morphometric vertebral fracture was 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). The 24-month cumulative incidence of new morphometric vertebral fracture was 3.3 % in the ZOL group versus 9.7 % in the placebo group (log-rank test: p = 0.0029; hazard ratio: 0.35; 95 % confidence interval: 0.17-0.72). The cumulative incidence of any clinical fracture, clinical vertebral fracture, and non-vertebral fracture was significantly reduced in the ZOL group by 54, 70, and 45 %, respectively, compared to the placebo group. At 24 months, ZOL administration increased bone mineral density in the lumbar spine, femoral neck, and total hip (t test: p < 0.0001). No new adverse events or osteonecrosis of the jaw were observed in this study.

CONCLUSIONS

Once-yearly administration of ZOL 5 mg to Japanese patients with primary osteoporosis reduced the risk of new morphometric vertebral fractures and was found to be safe.

Authors+Show Affiliations

Japan Osteoporosis Foundation, 11-2 Kobuna-cho, Nihonbashi, Chuo-ku, Tokyo, 103-0024, Japan. t-nak@utopia.ocn.ne.jp.Kawasaki Medical School, 577 Matsushima, Kurashiki City, Okayama, 701-0192, Japan.Tamana Central Hospital, 1950 Naka, Tamana City, Kumamoto, 865-0064, Japan.Nojima Hospital, 2714-1 Sesakimachi, Kurayoshi City, Tottori, 682-0863, Japan.Nagasaki University, 1-14 Bunkyomachi, Nagasaki City, Nagasaki, 852-8521, Japan.School of Health Science, Tottori University, 86 Nishicho, Yonago City, Tottori, 683-8503, Japan.Department of Nuclear Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki City, Okayama, 701-0192, Japan.Department of Oral and Maxillofacial Radiology, Matsumoto Dental University, 1780 Hirooka Gobara, Shiojiri City, Nagano, 399-0781, Japan.Asahi Kasei Pharma Corporation, 1-105 Jinbocho, Kanda, Chiyoda-ku, Tokyo, 101-8101, Japan.Asahi Kasei Pharma Corporation, 1-105 Jinbocho, Kanda, Chiyoda-ku, Tokyo, 101-8101, Japan.Asahi Kasei Pharma Corporation, 1-105 Jinbocho, Kanda, Chiyoda-ku, Tokyo, 101-8101, Japan.Research Institute and Practice for Involutional Diseases, 1610-1 Meisei, Misato, Azumino, Nagano, 399-8101, Japan.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27631091

Citation

Nakamura, T, et al. "Efficacy and Safety of Once-yearly Zoledronic Acid in Japanese Patients With Primary Osteoporosis: Two-year Results From a Randomized Placebo-controlled Double-blind Study (ZOledroNate Treatment in Efficacy to Osteoporosis; ZONE Study)." Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 28, no. 1, 2017, pp. 389-398.
Nakamura T, Fukunaga M, Nakano T, et al. Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). Osteoporos Int. 2017;28(1):389-398.
Nakamura, T., Fukunaga, M., Nakano, T., Kishimoto, H., Ito, M., Hagino, H., Sone, T., Taguchi, A., Tanaka, S., Ohashi, M., Ota, Y., & Shiraki, M. (2017). Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 28(1), 389-398. https://doi.org/10.1007/s00198-016-3736-y
Nakamura T, et al. Efficacy and Safety of Once-yearly Zoledronic Acid in Japanese Patients With Primary Osteoporosis: Two-year Results From a Randomized Placebo-controlled Double-blind Study (ZOledroNate Treatment in Efficacy to Osteoporosis; ZONE Study). Osteoporos Int. 2017;28(1):389-398. PubMed PMID: 27631091.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). AU - Nakamura,T, AU - Fukunaga,M, AU - Nakano,T, AU - Kishimoto,H, AU - Ito,M, AU - Hagino,H, AU - Sone,T, AU - Taguchi,A, AU - Tanaka,S, AU - Ohashi,M, AU - Ota,Y, AU - Shiraki,M, Y1 - 2016/09/08/ PY - 2016/06/07/received PY - 2016/08/08/accepted PY - 2016/9/16/pubmed PY - 2018/4/25/medline PY - 2016/9/16/entrez KW - Antiresorptives KW - Biochemical markers of bone turnover KW - Clinical trials KW - Fracture prevention KW - Osteoporosis SP - 389 EP - 398 JF - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JO - Osteoporos Int VL - 28 IS - 1 N2 - : In a 2-year randomized, placebo-controlled study of 665 Japanese patients with primary osteoporosis, once-yearly administration of zoledronic acid (5 mg) reduced the risk of new morphometric vertebral fractures. INTRODUCTION: The purpose of this study was to determine the efficacy and safety of once-yearly intravenous infusion of ZOL in Japanese patients with primary osteoporosis. METHODS: This was a two-year multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative study (ZONE Study). Subjects were 665 Japanese patients between the ages of 65 and 89 years who had prevalent vertebral fracture. Subjects were randomly assigned to receive once-yearly intravenous infusion of 5 mg of ZOL or placebo at baseline and 12 months. RESULTS: The 2-year incidence of new morphometric vertebral fracture was 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). The 24-month cumulative incidence of new morphometric vertebral fracture was 3.3 % in the ZOL group versus 9.7 % in the placebo group (log-rank test: p = 0.0029; hazard ratio: 0.35; 95 % confidence interval: 0.17-0.72). The cumulative incidence of any clinical fracture, clinical vertebral fracture, and non-vertebral fracture was significantly reduced in the ZOL group by 54, 70, and 45 %, respectively, compared to the placebo group. At 24 months, ZOL administration increased bone mineral density in the lumbar spine, femoral neck, and total hip (t test: p < 0.0001). No new adverse events or osteonecrosis of the jaw were observed in this study. CONCLUSIONS: Once-yearly administration of ZOL 5 mg to Japanese patients with primary osteoporosis reduced the risk of new morphometric vertebral fractures and was found to be safe. SN - 1433-2965 UR - https://www.unboundmedicine.com/medline/citation/27631091/Efficacy_and_safety_of_once_yearly_zoledronic_acid_in_Japanese_patients_with_primary_osteoporosis:_two_year_results_from_a_randomized_placebo_controlled_double_blind_study__ZOledroNate_treatment_in_Efficacy_to_osteoporosis L2 - https://doi.org/10.1007/s00198-016-3736-y DB - PRIME DP - Unbound Medicine ER -