Gutteridge D H, Holzherr M L, Retallack R W, Price R I, Will R K, Dhaliwal S S, Faulkner D L, Stewart G O, Stuckey B G A, Prince R L, Criddle R A, Drury P J, Tran L, Bhagat C I, Kent G N, Jamrozik K
Department of Endocrinology, Sir Charles Gairdner Hospital, Verdun Street, Nedlands, Western Australia 6009, Australia,
Calcif Tissue Int. 2003 Jul;73(1):33-43. doi: 10.1007/s00223-002-2023-4.
We report a prospective, randomized, multicenter, open-label 2-year trial of 81 postmenopausal women aged 53-79 years with at least one minimal-trauma vertebral fracture (VF) and low (T-score below - 2) lumbar bone mineral density (BMD). Group HRT received piperazine estrone sulfate (PES) 0.625 - 1.25 mg/d +/- medroxyprogesterone acetate (MPA) 2.5 - 5 mg/d; group HRT/D received HRT plus calcitriol 0.25 microg bd. All with a baseline dietary calcium (Ca) of < 1 g/ d received Ca carbonate 0.6 g nocte. Final data were on 66 - 70 patients. On HRT/D, significant (P < 0.001) BMD increases from baseline by DXA were at total body - head, trochanter, Ward's, total hip, intertrochanter and femoral shaft (% group mean delta 4.2, 6.1, 9.3, 3.7, 3.3 and 3.3%, respectively). On HRT, at these 6 sites, significant deltaS were restricted to the trochanter and Wards. Significant advantages of HRT/D over HRT were in BMD of total body (- head), total hip and trochanter (all P = 0.01). The differences in mean delta at these sites were 1.3, 2.6 and 3.9%. At the following, both groups improved significantly -lumbar spine (AP and lateral), forearm shaft and ultradistal tibia/fibula. The weightbearing, site - specific benefits of the combination associated with significant suppression of parathyroid hormone-suggest a beneficial effect on cortical bone. Suppression of bone turnover was significantly greater on HRT/D (serum osteocalcin P = 0.024 and urinary hydroxyproline/creatinine ratio P = 0.035). There was no significant difference in the number of patients who developed fresh VFs during the trial (HRT 8/36, 22%; HRT/D 4/34, 12% - intention to treat); likewise in the number who developed incident nonvertebral fractures. This is the first study comparing the 2 treatments in a fracture population. The results indicate a significant benefit of calcitriol combined with HRT on total body BMD and on BMD at the hip, the major site of osteoporotic fracture.
我们报告了一项前瞻性、随机、多中心、开放标签的为期2年的试验，该试验纳入了81名年龄在53 - 79岁之间的绝经后女性，她们至少有一处轻微创伤性椎体骨折（VF）且腰椎骨密度（BMD）较低（T值低于 - 2）。激素替代疗法（HRT）组接受硫酸哌嗪雌酮（PES）0.625 - 1.25 mg/天±醋酸甲羟孕酮（MPA）2.5 - 5 mg/天；激素替代疗法/钙三醇（HRT/D）组接受HRT加钙三醇0.25μg，每日两次。所有基线饮食钙（Ca）<1 g/天的患者每晚服用碳酸钙0.6 g。最终数据来自66 - 70名患者。在HRT/D组，通过双能X线吸收法（DXA）测量，全身 - 头部、大转子、沃德三角、全髋、转子间和股骨干的骨密度从基线显著增加（P < 0.001）（组平均变化百分比分别为4.2%、6.1%、9.3%、3.7%、3.3%和3.3%）。在HRT组，在这6个部位，显著变化仅限于大转子和沃德三角。HRT/D组相对于HRT组在全身（不包括头部）、全髋和大转子的骨密度方面具有显著优势（均P = 0.01）。这些部位的平均变化差异分别为1.3%、2.6%和3.9%。在以下部位，两组均有显著改善 - 腰椎（前后位和侧位）、前臂骨干和胫腓骨远端。这种联合疗法在负重部位的特定益处与甲状旁腺激素的显著抑制相关，提示对皮质骨有有益作用。HRT/D组对骨转换的抑制作用显著更大（血清骨钙素P = 0.024，尿羟脯氨酸/肌酐比值P = 0.035）。在试验期间发生新发椎体骨折的患者数量没有显著差异（HRT组8/36，22%；HRT/D组4/34，12% - 意向性治疗）；发生非椎体骨折的患者数量同样没有显著差异。这是第一项在骨折人群中比较这两种治疗方法的研究。结果表明，钙三醇与HRT联合使用对全身骨密度以及髋部（骨质疏松性骨折的主要部位）的骨密度有显著益处。
