Prolonged antiresorptive activity of zoledronate: A randomized, controlled trial
Open Access
- 7 April 2010
- journal article
- research article
- Published by Oxford University Press (OUP) in Journal of Bone and Mineral Research
- Vol. 25 (10), 2251-2255
- https://doi.org/10.1002/jbmr.103
Abstract
Annual intravenous administration of 5 mg of zoledronate decreases fracture risk over 3 years. The optimal dosing interval of 5 mg of zoledronate is not known. In order to determine the duration of the antiresorptive action of a single 5‐mg dose of intravenous zoledronate, we conducted a 3‐year double‐blind, randomized, placebo‐controlled trial in a volunteer sample of 50 postmenopausal women with osteopenia. The coprimary endpoints were the bone turnover markers β‐C‐terminal telopeptide of type I collagen (β‐CTX) and serum procollagen type‐I N‐terminal propeptide (P1NP). Secondary endpoints were bone mineral density (BMD) at the lumbar spine, total hip, and total body. After 3 years, mean (95% confidence interval) levels of serum β‐CTX and P1NP were 44% (27–60) and 40% (24%–56%) lower in the zoledronate group (p < .001 versus placebo for each marker). BMD was higher in the zoledronate group than in the placebo group by an average of 6.8% (4.6%–9.1%) at the lumbar spine, 4.0% (1.8%–6.3%) at the total hip, and 2.0% (0.9%–3.0%) at the total body (p < .001 for each skeletal site). Between‐group differences in markers of bone turnover and BMD were stable from 12 to 36 months. These data demonstrate that the antiresorptive effects of a single 5‐mg dose of zoledronate are sustained for 3 years; clinical trials to investigate the antifracture efficacy of dosing intervals longer than 1 year are justified. © 2010 American Society for Bone and Mineral Research.Keywords
This publication has 11 references indexed in Scilit:
- Zoledronic Acid for the Prevention of Bone Loss in Postmenopausal Women With Low Bone MassObstetrics & Gynecology, 2009
- The Antiresorptive Effects of a Single Dose of Zoledronate Persist for Two Years: A Randomized, Placebo-Controlled Trial in Osteopenic Postmenopausal WomenJournal of Clinical Endocrinology & Metabolism, 2009
- Effects of Intravenous Zoledronate on Bone Turnover and BMD Persist for at Least 24 MonthsJournal of Bone and Mineral Research, 2008
- Establishing a reference range for bone turnover markers in young, healthy womenBone, 2008
- Zoledronic Acid and Clinical Fractures and Mortality after Hip FractureNew England Journal of Medicine, 2007
- Once-Yearly Zoledronic Acid for Treatment of Postmenopausal OsteoporosisNew England Journal of Medicine, 2007
- Compliance with osteoporosis therapy is the weakest linkThe Lancet, 2006
- Change in Bone Turnover and Hip, Non-Spine, and Vertebral Fracture in Alendronate-Treated Women: The Fracture Intervention TrialJournal of Bone and Mineral Research, 2004
- Intravenous Zoledronic Acid in Postmenopausal Women with Low Bone Mineral DensityNew England Journal of Medicine, 2002
- Effects of Risedronate Treatment on Vertebral and Nonvertebral Fractures in Women With Postmenopausal OsteoporosisA Randomized Controlled TrialJama-Journal Of The American Medical Association, 1999