Atamaz F, Hepguler S, Akyildiz M, Karasu Z, Kilic M
Department of Physical Therapy and Rehabilitation, Medical Faculty of Ege University, Bornova-Izmir, Turkey.
Osteoporos Int. 2006;17(6):942-9. doi: 10.1007/s00198-006-0082-5. Epub 2006 Mar 21.
The purpose of this study was to evaluate the effects of alendronate (ALN) on bone mineral density (BMD) and bone turnover markers in patients with orthotopic liver transplantation (OLT).
In the prospective, controlled, open study with 24 months of follow-up, 98 patients with OLT were randomised to receive ALN 70 mg weekly or no ALN; calcium (Ca) 1,000 mg daily and 0.5 mcg calcitriol daily were provided to all patients. Lumbar spine (LS) and hip BMDs were measured at 6-month intervals by dual-energy X-ray absorptiometry (DEXA). Spinal radiographs were obtained to assess vertebral fractures. Additionally, bone turnover markers, serum parathyroid hormone (PTH) and biochemical parameters were determined every 3 months.
Compared with the control group, the ALN group showed significant increases in BMD of the LS (5.1+/-3.9% vs 0.4+/-4.2%, p<0.05 at 12 months, 8.9+/-5.7% vs 1.4+/-4.9%, p<0.05 at 24 months), femoral neck (4.3+/-3.8% vs -1.1+/-3.1%, p<0.05 at 12 months, 8.7+/-4.8% vs 0.6+/-4.5%, p<0.05 at 24 months) and total femur (3.6+/-3.8% vs -0.6+/-4.0%, p<0.05 at 12 months, 6.2+/-3.8% vs 0.3+/-4.6%, p<0.05 at 24 months). In the ALN group, osteocalcin and urinary deoxypyridinoline (DPD) decreased significantly at the sixth month, with no further change, by -35.6% and -63.0%, on average, respectively (p<0.05). In the control group, a significant increase in biochemical markers of bone turnover was observed in comparison to baseline values (p<0.05). PTH increased within reference levels without a difference between groups. Two nonvertebral fractures (4.2%) and nine vertebral fractures (18.8%) in the control group and three vertebral fractures (6.8%) in the ALN group occurred during the follow-up. The weekly ALN was well tolerated, and no severe side effects occurred.
This is the first randomised study including a control group to demonstrate that weekly ALN was able to significantly increase BMD in patients with OLT when compared with Ca and calcitriol alone. However, ALN did not appear to offer protection against fractures.
本研究旨在评估阿仑膦酸钠（ALN）对原位肝移植（OLT）患者骨矿物质密度（BMD）和骨转换标志物的影响。
在这项为期24个月随访的前瞻性、对照、开放性研究中，98例OLT患者被随机分为两组，一组每周接受70mg ALN，另一组不接受ALN；所有患者均每日补充1000mg钙（Ca）和0.5μg骨化三醇。每隔6个月采用双能X线吸收法（DEXA）测量腰椎（LS）和髋部的骨密度。拍摄脊柱X光片以评估椎体骨折情况。此外，每3个月测定一次骨转换标志物、血清甲状旁腺激素（PTH）和生化参数。
与对照组相比，ALN组患者的腰椎骨密度在12个月时显著增加（5.1±3.9% vs 0.4±4.2%，p<0.05），24个月时增加更为明显（8.9±5.7% vs 1.4±4.9%，p<0.05）；股骨颈骨密度在12个月时增加（4.3±3.8% vs -1.1±3.1%，p<0.05），24个月时进一步增加（8.7±4.8% vs 0.6±4.5%，p<0.05）；全股骨骨密度在12个月时增加（3.6±3.8% vs -0.6±4.0%，p<0.05），24个月时增加（6.2±3.8% vs 0.3±4.6%，p<0.05）。在ALN组，骨钙素和尿脱氧吡啶啉（DPD）在第6个月时显著下降，之后无进一步变化，平均分别下降了35.6%和63.0%（p<0.05）。与基线值相比，对照组骨转换生化标志物显著增加（p<0.05）。PTH在参考范围内升高，两组间无差异。随访期间，对照组发生了2例非椎体骨折（4.2%）和9例椎体骨折（18.8%），ALN组发生了3例椎体骨折（6.8%）。每周一次的ALN耐受性良好，未出现严重副作用。
这是第一项纳入对照组的随机研究，结果表明与单独补充钙和骨化三醇相比，每周一次的ALN能够显著提高OLT患者的骨密度。然而，ALN似乎并不能预防骨折。
