Boutsen Y, Jamart J, Esselinckx W, Devogelaer J P
Department of Rheumatology, Université Catholique de Louvain, University Hospital in Mont-Godinne, Yvoir, Belgium.
J Bone Miner Res. 2001 Jan;16(1):104-12. doi: 10.1359/jbmr.2001.16.1.104.
The aim of this study was to compare the action of two regimens of intravenous (iv) pamidronate in the primary prevention of glucocorticoid-induced osteoporosis (GC-OP). The primary purpose of the study was to determine whether any differences in bone mineral density (BMD) appeared after 1 year. A secondary endpoint aimed at assessing the remodeling parameters in order to better understand the mechanisms of action of the various regimens. Thirty-two patients, who required first-time, long-term glucocorticoid therapy at a daily dose of at least 10 mg of prednisolone, were studied. Simultaneously with the initiation of their glucocorticoid treatment, patients also were randomly allocated to receive a single iv infusion of 90 mg of pamidronate at the start (group A); a first infusion of 90 mg of pamidronate followed, subsequently, by an iv infusion of 30 mg pamidronate every 3 months (group B); and a daily 800-mg elemental calcium supplement given as calcium carbonate (group C), which also was taken by patients in groups A and B. Patients were matched for starting glucocorticoid doses, sex, menopausal status, and hormonal replacement therapy. Lumbar spine and hip (total and subregions) BMDs were measured at the outset and repeated at 6-month intervals by dual-energy X-ray absorptiometry (DXA; Hologic QDR-2000). Bone turnover was assessed by measurement of total and bone-specific serum alkaline phosphatase activity (B-ALP), serum osteocalcin (OC), and serum C-telopeptide cross-links of type I collagen (CTX). After 1 year, the mean BMD changes for groups A, B, and C were, respectively, 1.7, 2.3, and -4.6% at the lumbar spine; 1.2, 1.2, and -3.1% at the femoral neck; 1.0, 2.6, and -2.2% for the total hip region. No difference was observed between pamidronate regimens but a highly significant difference was observed between both pamidronate regimens and the control group at the lumbar spine (p < 0.001), at the femoral neck (p < 0.01), and for the total hip (p < 0.05). A significant decrease of serum C-telopeptide was observed, after 3 months, in groups A and B (p = 0.029), but a sustained decrease of bone resorption over time was observed only in group B. As far as BMD evolution over 1 year was concerned, iv pamidronate, given either as a single infusion or once every 3 months, effectively achieved primary prevention of GC-OP.
本研究的目的是比较两种静脉注射帕米膦酸盐方案在糖皮质激素诱导的骨质疏松症(GC-OP)一级预防中的作用。该研究的主要目的是确定1年后骨矿物质密度(BMD)是否出现任何差异。次要终点旨在评估重塑参数,以便更好地理解各种方案的作用机制。对32例首次需要长期接受每日至少10 mg泼尼松龙糖皮质激素治疗的患者进行了研究。在开始糖皮质激素治疗的同时,患者还被随机分配,在开始时接受单次静脉输注90 mg帕米膦酸盐(A组);先输注90 mg帕米膦酸盐,随后每3个月静脉输注30 mg帕米膦酸盐(B组);以及给予每日800 mg元素钙补充剂碳酸钙(C组),A组和B组患者也服用该补充剂。对患者的起始糖皮质激素剂量、性别、绝经状态和激素替代疗法进行了匹配。在研究开始时测量腰椎和髋部(整体及各亚区域)的骨密度,并通过双能X线吸收法(DXA;Hologic QDR-2000)每6个月重复测量一次。通过测量血清总碱性磷酸酶活性和骨特异性碱性磷酸酶活性(B-ALP)、血清骨钙素(OC)以及I型胶原的血清C-末端肽交联(CTX)来评估骨转换。1年后,A组、B组和C组在腰椎的平均骨密度变化分别为1.7%、2.3%和-4.6%;在股骨颈分别为1.2%、1.2%和-3.1%;在全髋区域分别为1.0%、2.6%和-2.2%。在帕米膦酸盐方案之间未观察到差异,但在腰椎(p < 0.001)、股骨颈(p < 0.01)和全髋(p < 0.05)处,两种帕米膦酸盐方案与对照组之间均观察到高度显著差异。3个月后,A组和B组血清C-末端肽显著降低(p = 0.029),但仅在B组观察到随着时间推移骨吸收持续降低。就1年内的骨密度变化而言,单次静脉输注或每3个月输注一次的静脉注射帕米膦酸盐有效地实现了GC-OP的一级预防。