Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Cleveland, OH, USA.
MetroHealth Medical Center, SCI Program, 4229 Pearl Road, Cleveland, OH, USA.
Spinal Cord. 2020 Aug;58(8):921-929. doi: 10.1038/s41393-020-0431-9. Epub 2020 Feb 13.
Randomized double blind, placebo-controlled trial.
To examine the effect of early intravenous zoledronic acid (ZA) on bone markers and areal bone mineral density (aBMD) in persons with acute ASIA Impairment Scale (AIS) A traumatic spinal cord injury (SCI).
Two inpatient rehabilitation units.
Thirteen men, 2 women, aged 19-65, C4-T10 AIS A SCI, received 5 mg intravenous ZA vs. placebo 12-21 days post injury. Markers of bone formation (procollagen N-1 terminal propeptide [P1NP]), bone resorption (serum C-telopeptide [CTX]), and aBMD by dual-energy X-ray absorptiometry (DXA) for hip (femur-proximal, intertrochanteric, neck), and knee (distal femur, proximal tibia) were obtained at baseline, 2 weeks post infusion (P1NP, CTX only), 4 and 12 months post injury.
P1NP remained unchanged, while CTX decreased in ZA but increased in controls at 2 weeks (mean difference = -97%, p < 0.01), 4 months (mean difference = -54%, p < 0.05), but not 12 months (mean difference = 3%, p = 0.23). Changes in aBMD at the hip favored ZA at 4 months (mean difference 10.3-14.1%, p < 0.01) and 12 months (mean difference 10.8-13.1%, p < 0.02). At 4 months, changes in aBMD favored ZA at the distal femur (mean difference 6.0%, 95% CI: 0.7-11.2, p < 0.03) but not proximal tibia (mean difference 8.3%, 95% CI: -6.9 to 23.6, p < 0.23). Both groups declined in aBMD at 12 months, with no between group differences.
ZA administered ≤21 days of complete traumatic SCI maintains aBMD at the hip and distal femur at 4 months post injury. This effect is partially maintained at 12 months.
随机双盲、安慰剂对照试验。
研究早期静脉注射唑来膦酸（ZA）对急性美国脊髓损伤协会（AIS）A 级创伤性脊髓损伤（SCI）患者骨标志物和面积骨密度（aBMD）的影响。
两个住院康复病房。
13 名男性和 2 名女性，年龄 19-65 岁，C4-T10 AIS A SCI，在损伤后 12-21 天接受 5mg 静脉注射 ZA 或安慰剂。在基线时、输注后 2 周（仅 P1NP、CTX）、4 个月和 12 个月时，通过双能 X 射线吸收法（DXA）获得骨形成标志物（前胶原 N-端前肽[P1NP]）、骨吸收标志物（血清 C-端肽[CTX]）和髋部（股骨近端、转子间、颈部）、膝部（股骨远端、胫骨近端）的 aBMD。
ZA 组的 P1NP 保持不变，而对照组在 2 周时 CTX 下降（平均差异=-97%，p<0.01），4 个月时（平均差异=-54%，p<0.05），但 12 个月时（平均差异=3%，p=0.23）没有变化。髋部 aBMD 的变化在 4 个月时（平均差异 10.3-14.1%，p<0.01）和 12 个月时（平均差异 10.8-13.1%，p<0.02）有利于 ZA。在 4 个月时，ZA 组在股骨远端的 aBMD 变化更优（平均差异 6.0%，95%CI：0.7-11.2，p<0.03），但在胫骨近端（平均差异 8.3%，95%CI：-6.9 至 23.6，p<0.23）则不然。两组在 12 个月时的 aBMD 均下降，组间无差异。
在完全性创伤性 SCI 后≤21 天给予 ZA 可维持髋部和股骨远端的 aBMD 在损伤后 4 个月。这种效果在 12 个月时部分维持。
