Durability and delayed treatment effects of zoledronic acid on bone loss after spinal cord injury: A randomized, controlled trial
The objective of this study was to examine the effects of timing and frequency of ZOL over 2 years. In this double-blind, placebo-controlled trial, we randomized 60 individuals with acute SCI (<120 days of injury) to receive either ZOL 5 mg infusion (n=30) or placebo (n=30). After 12 months, groups were again randomized to receive ZOL or placebo, resulting in four treatment groups for year 2: 1) ZOL both years, 2) ZOL year 1, placebo year 2, 3) placebo year 1, ZOL year 2, and 4) placebo bot h years. Our primary outcome was bone loss at 12 months; compared to placebo, a single infusion of ZOL attenuated bone loss at the proximal femur, where median changes relative to baseline were -1.7 to -2.2% for ZOL vs. -11.3 to -12.8% for placebo ( p<0.001). Similarly, the distal femur and proximal tibia demonstrated changes of -4.7 to -9.6% for ZOL vs. -8.9 to -23.0% for placebo (p ≤0.042). After 24 months, differences were significant at the proximal femur only (-3.2 to -6.0% for ZOL vs. -16.8 to -21.8% for placebo; p≤0.018). Although not statistically significant, median bone density losses suggested some benefit from two annual infusions compared to a single baseline in fusion, as well as from a single infusion 12 months after baseline compared to two years of placebo; therefore, further investigation in the 12 to 24-month treatment window is warranted. No unanticipated adverse events associated with drug treatment were observed. In summary, ZOL 5 mg infusion after acu...
Source: Journal of Bone and Mineral Research - Category: Orthopaedics Authors: W. Brent Edwards,
Ifaz T. Haider,
Narina Simonian,
Joana Barroso,
Thomas J. Schnitzer Tags: Clinical Trial Source Type: research
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