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Low-dose zoledronate in osteopenic postmenopausal women: a randomized controlled trial
Andrew Grey1, Mark Bolland, Sumwai Wong
1Department of Medicine, University of Auckland, Private Bag 92 019, Auckland, New Zealand. a.grey@auckland.ac.nz
The Journal of Clinical Endocrinology and Metabolism
|November 11, 2011
Summary
Single doses of zoledronate below 5 mg demonstrated significant bone mineral density increases and reduced bone turnover in postmenopausal women. Further trials are warranted to assess the fracture efficacy of these lower zoledronate doses.
Area of Science:
- Bone biology and osteoporosis research
- Pharmacology and drug development
Background:
- Annual intravenous administration of 5 mg zoledronate is established for decreasing fracture risk.
- The skeletal effects of zoledronate doses below 4 mg have not been previously evaluated.
Purpose of the Study:
- To investigate the skeletal effects of single intravenous doses of zoledronate at 5 mg or less.
- To assess changes in bone mineral density and bone turnover markers.
Main Methods:
- A 1-year, double-blind, randomized, placebo-controlled trial involving 180 postmenopausal women with osteopenia.
- Single intravenous administration of zoledronate (1 mg, 2.5 mg, or 5 mg) or placebo.
- Primary endpoint: change in lumbar spine bone mineral density (BMD); Secondary endpoints: changes in hip and total body BMD, and bone turnover markers.
Main Results:
- All zoledronate dose groups showed statistically significant increases in lumbar spine and total hip BMD compared to placebo after 12 months.
- Bone turnover markers (β-CTX and P1NP) were significantly reduced by at least 40% in all zoledronate groups compared to placebo.
- A dose-dependent effect of zoledronate was observed on bone turnover markers.
Conclusions:
- Single intravenous doses of zoledronate below 5 mg exhibit significant antiresorptive effects.
- These findings support the justification for clinical trials to evaluate the antifracture efficacy of lower zoledronate doses.
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