Treatment of established osteoporosis with 1α (OH) vitamin D3 and low dose intermittent elcatonin (eel calcitonin derivative)

In addition to estrogen widely used all over the world for the prevention of postmenopausal osteoporosis, calcitonin and vitamin D derivatives are commonly employed to treat established osteoporosis at higher age in Japan. In order to critically assess the usefulness of vitamin D derivatives and calcitonin alone or in combination on the advancement of vertebral deformity at higher age, 32 osteoporotic patients with vertebral deformity with the mean age of 79 were randomly divided into 4 groups with indistinguishable age and severity of the vertebral deformity. Group 1 served as the control without specific medications for osteoporosis. Group 2 was treated with 10 units elcatonin (eel calcitonin derivative) injected intramuscularly twice a week. Group 3 was given 0.75 to 1.5μg/day 1α (OH) vitamin D₃ orally. Group 4 was given a combination of treatments used in Groups 2 and 3. In the lateral X-ray film of the spine taken prior to the test and every 6 months thereafter, the shape of the vertebral body T₈ through L₄ was monitored by measuring the anterior, central and posterior heights. Decrease of the vertebral height ratio; anterior or middle height/posterior or adjacent intact posterior height, by more than 20% of the original value or from above to below 0.80 both appeared to be inhibited during administration of 1α (OH) vitamin D₃. Such effect seems to be augmented by simultaneous administration of elcatonin. Actual decrease of vertebral height ratio values and the per cent fall from the original value significantly less in Groups 3 and 4 than in Group 1. Development of vertebral deformity assessed by the changes of the vertebral height thus appears to decrease during treatment with 1α (OH) vitamin D₃ especially together with calcitonin in established osteoporosis.     

重组人PTH(1-34)与依降钙素对绝经后女性骨质疏松患者骨代谢和血清SPARC的影响

目的 观察重组人甲状旁腺素(1-34)[ rhPTH(1-34)]和依降钙素对绝经后女性骨质疏松患者骨密度和骨代谢及血清富含半胱氨酸的酸性蛋白( SPARC)水平的影响.方法 124例绝经后女性骨质疏松症患者随机分为PTH组(n=89),给予rhPTH (1-34)200 U皮下注射每日一次和CT组(n=35),给予依降钙素20U肌肉注射每周一次,共12个月.于治疗前、治疗后6个月、12个月测定各组一般生化指标,腰椎L2-4、左股骨颈、大转子及Ward三角的骨密度、血清钙、磷水平.采用酶联免疫法(ELISA)测定血清骨碱性磷酸酶(BSAP)、富含半胱氨酸的酸性蛋白(SPARC)等骨代谢相关指标水平情况.结果 rhPTH治疗12个月后腰椎L2-4骨密度较基线增加了7.9％(P＜0.05);血清钙和BSAP水平12个月时较治疗前分别增加了8.3％和93.4％(均P＜0.05);血清SPARC水平12个月时较基线增加了12.6％(P＜0.05);与治疗前相比,依降钙素治疗12个月时腰椎L2-4骨密度增加了3.2％(P＜0.05);血清钙、BSAP和SPARC水平均无显著改变.结论 rhPTH (1-34)能显著促进骨合成代谢,其疗效优于依降钙素;血清SPARC水平的增加可能在rhPTH促进成骨过程中起重要作用.     

Health-related quality of life (HRQOL) in Japanese osteoporotic patients and its improvement by elcatonin treatment

Health-related quality of life (HRQOL; QOL hereafter) was evaluated in Japanese osteoporotic patients using three questionnaires; the SF-36 (MOS 36-Item Short-Form Health Survey; generic, profile-type), the EQ-5D (Euro Qol-5 Dimensions; generic, preference-based), and the JOQOL (Japanese Osteoporosis Quality of Life 1999; disease-targeted). The eight subscales and two summary scores of the SF-36 were impaired in these patients even after correction for age and sex. The scores on the EQ-5D and JOQOL correlated well with the subscales of the SF-36 that represent the physical aspects of physical function and bodily pain, which suggests that physical aspects are important determinants of overall QOL status in osteoporotic patients. Although the QOL scores did not correlate with bone mineral density, they were markedly influenced by the presence of vertebral fractures. In particular, the presence of two or more vertebral fractures greatly decreased the QOL scores. We then evaluated the QOL scores before and after treatment. The patients were either given calcium supplementation alone or calcium plus once-weekly elcatonin (Elcitonin, Asahi Kasei Pharma, Tokyo, Japan) injection. Elcatonin treatment markedly improved diverse aspects of the QOL, whereas calcium alone did not. The current data suggest that osteoporosis, especially in the presence of vertebral fracture, is associated with compromised QOL, and therapeutic intervention for osteoporosis should be evaluated in terms of QOL, as well as in terms of increases in bone mineral density and fracture prevention.     

益钙宁治疗骨质疏松症骨痛45例疗效观察

益钙宁(人工合成鳗鱼降钙素,Elcatonin)治疗原发性骨质疏松症45例,有明显的减轻骨痛和改善活动功能的效果,有效率为91.1％,31例(占68.9％)病人停药后改善疼痛作用持续1个月以上。血TRAP和尿Ftyp排量在用约后均有明显降低,支持此药行抑制破骨细胞活性的作用。仅用药初期少数病人有轻微脸红、心悸或恶心等副作用。可自行缓解或对症处理后消失。     

Effects of 5-year treatment with elcatonin and alfacalcidol on lumbar bone mineral density and the incidence of vertebral fractures in postmenopausal women with osteoporosis: a retrospective study

 The purpose of this retrospective study was to compare the effects of long-term treatment (5 years) with elcatonin and alfacalcidol on bone mineral density (BMD) and the incidence of vertebral fractures in postmenopausal women with osteoporosis. Fifty-six osteoporotic women, more than 5 years after menopause and 58–79 years of age, were enrolled in the study and allocated to an elcatonin treatment group (20 units IM, weekly; n = 30) or an alfacalcidol treatment group (1 μg/day, daily; n = 26). BMD of the lumbar spine (L2-L4) was measured by dual energy X-ray absorptiometry at baseline and every year for 5 years. There were no significant differences in age, body mass index, years since menopause, BMD, or number of prevalent vertebral fractures at baseline between the two groups. One-way analysis of variance with repeated measurements showed no significant longitudinal changes in BMD in either group, suggesting that both treatments sustained the BMD over 5 years. Two-way analysis of variance with repeated measurements also showed no significant differences in longitudinal changes in BMD between the two groups, suggesting that the effects of the two treatments on BMD were similar. However, the number of incident vertebral fractures per patient was significantly lower in the alfacalcidol treatment group than in the elcatonin treatment group (0.80 ± 1.19 and 2.08 ± 2.73, respectively; P < 0.05). These findings indicate that both treatments appeared to sustain lumbar BMD similarly over a 5-year period in postmenopausal women with osteoporosis, but alfacalcidol treatment may be superior to elcatonin treatment regarding the incidence of vertebral fractures. Further study with prospective observations are needed to confirm the results of the present study. Received: April 2, 2002 / Accepted: July 13, 2002 Offprint requests to: J. Iwamoto     

Effects of combined elcatonin and alendronate treatment on the architecture and strength of bone in ovariectomized rats

We examined the combined effects of elcatonin (ECT) and alendronate (ALN) on bone mass, architecture, and strength in ovariectomized (OVX) rats. Fifty female Sprague Dawley rats, aged 13 weeks, were divided into Sham, OVX, OVX+ECT, OVX+ALN, and OVX+ECT+ALN groups (n = 10). Immediately after ovariectomy, ECT was administered at a dose of 15 units (U)/kg three times a week, and ALN was administered daily at a dose of 2.0 µg/kg, subcutaneously for 12 weeks. The three-dimensional architecture of the bone in the distal femoral metaphysis was analyzed using a microfocus X-ray computed tomography system (µCT), and bone strength was measured using a material-testing machine. Trabe-cular bone volume (BV/TV) and number (Tb.N) were significantly greater in the OVX+ECT and OVX+ALN groups than in the OVX group. In the OVX+ECT+ALN group, BV/TV and Tb.N were significantly greater when compared with those in the OVX+ECT and OVX+ALN groups. Trabecular thickness (Tb.Th) was significantly greater in the OVX+ECT+ALN group than in the OVX+ALN group. With regard to bone strength, the compression strength in the femoral metaphysis was significantly lower in the OVX group than in the Sham group. The reduction of compression strength was slightly lower in the OVX+ECT and OVX+ALN groups. In the OVX+ECT+ALN group, the compression strength in the femoral metaphysis significantly increased when compared with the OVX and OVX+ECT groups. These results suggest that the combined treatment of ECT and ALN does not alter the individual effects of each drug and that it exerts an additive effect on trabecular architecture and bone strength in OVX rats.     

益钙宁治疗原发性骨质疏松10例临床观察

我们用益钙宁治疗原发性骨质疏松患者１０例，显示有明显减轻骨痛和改善活动功能的疗效，除１例经证实为多发性骨髓瘤疗效较差外，均取得明显改善，总有效率９２．８％。副作用见１酌轻度恶心，头痛，１例发生黄疸，药物性肝炎。     

中西医结合治疗骨质疏松症疗效观察

目的观察中西医结合治疗老年骨质疏松症(OP)1 a的疗效。方法选取老年骨质疏松症患者30例,在补骨脂颗粒、依降钙素联合使用3个月后,改用仙灵骨葆、福善美、阿法骨化醇口服,联合连续使用9个月。测定治疗前后腰椎、股骨颈与全髋的骨密度(BMD)。结果除L1BMD外,L1T值和L2、L3、L4、L2—4、股骨颈、股骨粗隆、全髋的BMD及T值均上升;其中L3、股骨粗隆的BMD和T值治疗前后比较有显著性差异,其余治疗前后比较均无显著性差异。结论中西医结合治疗老年骨质疏松症疗效较好,可以明显提高BMD。     

依降钙素治疗老年骨质疏松症的临床疗效观察

目的探讨依降钙素治疗老年骨质疏松症的疗效。方法 92例诊断为骨质疏松症的老年患者,随机分为依降钙素组46例,常规治疗组(对照组)46例,对照组口服维生素E,30 mg/次,4次/d,3个月为1个疗程;依降钙素组在常规治疗基础上加用依降钙素治疗,每次肌内注射20 U,2次/周,连续4周,后改为1次/周,3个月为1个疗程,观察两组临床疗效、视觉模拟评分(VAS)、骨密度、血钙、血磷的差异。结果依降钙素组总有效率为100.00%,对照组总有效率为28.26%,依降钙素组的疗效显著优于对照组,差异具有统计学意义(P<0.01);经治疗后两组患者疼痛较治疗前有明显改善,依降钙素组显著优于对照组,差异具有统计学意义(P<0.01);经治疗后L4、L5骨密度有不同程度的增加,依降钙素组显著优于对照组,差异具有统计学意义(P<0.01);经治疗后两组血钙均有不同程度的增加,依降钙素组显著优于对照组,差异具有统计学意义(P<0.01)。结论依降钙素是治疗老年骨质疏松症的疗效可靠、安全的药物,值得临床推广使用。     

益钙宁治疗绝经后骨质疏松的骨密度和骨转换指标的改变

目的为观察绝经后骨质疏松妇女应用益钙宁长期治疗４８周至７２周对骨密度（ＢＭＤ）及骨转换生化指标的影响。方法３３例患者应用益钙宁（２０单位／次，１次／周）加乳酸钙（元素钙，５００ｍｇ／日）治疗，另３５例患者单纯用乳酸钙（元素钙５００ｍｇ／日）治疗。结果应用益钙宁加钙治疗组患者腰椎２～４ＢＭＤ在治疗２４周始即有明显增加并持续至７２周；股骨近端的ＢＭＤ增加，Ｗａｒｄｓ三角区部位见于２４周到４８周；股骨颈部位见于４８周和７２周；大转子部位仅在７２周。血ＢＧＰ水平治疗２４周呈增高的改变，而血ＴＲＡＰ和尿ＨＹＰ／Ｃｒ比值的改变于治疗２４周、４８周和７２周均有明显的下降。单纯用钙对照组于治疗后与治疗前比较未见明显改变。结论本研究结果提示益钙宁长期治疗可抑制骨吸收并可能刺激骨形成，预防骨量丢失并增加骨量