The present study was designed to determine if levels of serum cytokines, such as interleukin (IL) -1beta, IL-2, IL-2r, IL-6, IL-6r, IL-8, IL-10, and TNF-alpha are different in osteoporotic and non-osteoporotic postmenopausal women, and to evaluate the effects of calcitonin and alendronate therapies over a six month period on serum cytokine levels in postmenopausal osteoporotic women. Serum levels of IL-2, TNF-alpha and IL-8 were found to be significantly higher (p < 0.05), and serum IL-10, and IL-6r significantly lower in the calcitonin (N=60) and the alendronate (N=60) treatment groups than in the control group (N=50) (p < 0.05). But, no significant difference was apparent between the calcitonin and alendronate treated groups before treatment. Statistically significant changes occurred in patients, with respect to the levels of serum IL-6r, and IL-8 after one month (p < 0.05), in IL-2r, IL-6r, IL-8, IL-10 after three months, and in IL-1beta, IL-6r, IL-8, IL-10 and TNF-alpha after six months of calcitonin therapy (p < 0.05). No significant difference was observed in IL-6r after one month, in IL-8 and IL-10 after three months, and in TNF-alpha after six months in the calcitonin treated group and in the control group, whereas these parameters were significantly different at baseline. In the alendronate treated group, statistically significant changes occurred in the levels of serum IL-1alpha and IL-6 after three months, and in IL-1beta, IL-6, IL-6r and TNF-alpha after six months (p < 0.05). No significant difference was observed in IL-6r after one month, in IL-10 after three months or in TNF-alpha after six months between the alendronate treatment group and the control group, whereas these parameters were significantly different at baseline. In conclusion, we suggest that; 1) not only IL-1, IL-6, TNF-alpha and IL-11 but also IL-2, IL-8 and IL-10 may have roles in the etiopathogenesis of osteoporosis, 2) calcitonin therapy have a more distinct influence on serum levels of some cytokines and have an earlier effect than alendronate therapy (especially upon IL-2r, IL-8, and IL-10). Nevertheless, further longitudinal studies are needed to identify the cytokines involved in the pathogenesis of postmenopausal osteoporosis and to evaluate the influence of different treatments on these cytokines.
Aged ; Alendronate/*therapeutic use ; Calcitonin/*therapeutic use ; Cytokines/*metabolism ; Female ; Human ; Middle Aged ; Osteoporosis, Postmenopausal/*drug therapy/*metabolism ; Time Factors

OBJECTIVETo investigate the effectiveness of alendronate Chinese national product in the prevention and treatment of postmenopausal osteoporosis.

METHODSThe 56 postmenopausal women with osteopenia or osteoporosis were randomly divided into two groups: treated with alendronate 10 mg/d (28 cases) orally and placebo (28 cases), for 6 months. All subjects received 600 mg/d of calcium carbonate and vitamin D 1,000 U/d. Bone mineral density (BMD) of the lumbar spine, femoral neck, trochanter and Ward's triangle were measured by dual energy X-ray absorptiometry as well as the markers of bone turnover were analysed at the beginning and the end of the study.

RESULTSThe results showed that lumbar spine BMD increased by 5% in the alendronate group (P < 0.01), but decreased in BMD of the lumbar spine and femur in the placebo group (P < 0.05) after 6 months of treatment. In the alendronate group the marker of bone resorption and bone formation were significantly decreased after alendronate therapy. There were no change in placebo group.

CONCLUSIONSAlendronate (Chinese national product) is effective in reducing bone turnover and promoting bone mass of postmenopausal osteoporosis.

Absorptiometry, Photon ; Aged ; Alendronate ; therapeutic use ; Bone Density ; Female ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal ; drug therapy ; prevention & control

Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D3 (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients.
Adult ; Aged ; Alendronate/adverse effects/*therapeutic use ; Cholecalciferol/adverse effects/deficiency/*therapeutic use ; Female ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal/*drug therapy ; Vitamin D Deficiency/*drug therapy

BACKGROUNDA new treatment strategy is to target specific areas of the skeletal system that are prone to clinically significant osteoporotic fractures. We term this strategy as the "local treatment of osteoporosis". The study was performed to investigate the effect of alendronate-loaded calcium phosphate cement (CPC) as a novel drug delivery system for local treatment of osteoorosis.

METHODSAn in vitro study was performed using CPC fabricated with different concentrations of alendronate (ALE, 0, 2, 5, 10 weight percent (wt%)). The microstructure, setting time, infrared spectrum, biomechanics, drug release, and biocompatibility of the composite were measured in order to detect changes when mixing CPC with ALE. An in vivo study was also performed using 30 Sprague-Dawley rats randomly divided into six groups: normal, Sham (ovariectomized (OVX) + Sham), CPC with 2% ALE, 5%ALE, and 10% ALE groups. At 4 months after the implantation of the composite, animals were sacrificed and the caudal vertebrae (levels 4-7) were harvested for micro-CT examination and biomechanical testing.

RESULTSThe setting time and strength of CPC was significantly faster and greater than the other groups. The ALE release was sustained over 21 days, and the composite showed good biocompatibility. In micro-CT analysis, compared with the Sham group, there was a significant increase with regard to volumetric bone mineral density (BMD) and trabecular number (Tb.N) in the treated groups (P < 0.05). Trabecular spacing (Tb.Sp) showed a significant increase in the Sham group compared to other groups (P < 0.01). However, trabecular thickness (Tb.Th) showed no significant difference among the groups. In biomechanical testing, the maximum compression strength and stiffness of trabecular bone in the Sham group were lower than those in the experimental groups.

CONCLUSIONSThe ALE-loaded CPC displayed satisfactory properties in vitro, which can reverse the OVX rat vertebral trabecular bone microarchitecture and biomechanical properties in vivo.

Alendronate ; therapeutic use ; Animals ; Bone Cements ; chemistry ; therapeutic use ; Bone Density ; drug effects ; Calcium Phosphates ; chemistry ; Female ; Osteoporosis ; drug therapy ; Rats ; Rats, Sprague-Dawley

We investigated the effects and optimal treatment frequency of pulsed electromagnetic fields (PEMFs) on postmenopausal osteoporosis (PMO). A comparison was performed with the cyclical alendronate and a course of PEMFs in the treatment for postmenopausal osteoporosis on bone mineral density (BMD), pain intensity and balance function. There was no significant difference between the two groups on mean percentage changes from baseline of BMD within 24 weeks after random treatments (P > or = 0.05). However, at the ends of 48 weeks and 72 weeks, the BMD of the PEMFs group were significantly lower than that of the alendronate group (P < 0.05). No significant difference was detected between the two groups with regard to treatment effects on Visual Analogue Scale score, the Timed Up & Go Test and Berg Balance Scale score. Compared with cyclical alendronate, a course of PEMFs was as effective as alendronate in treating PMO for at least 24 weeks. So its optimal treatment frequency for PMO may be one course per six months.
Alendronate ; therapeutic use ; Bone Density ; Bone Density Conservation Agents ; therapeutic use ; Electromagnetic Fields ; Female ; Humans ; Magnetic Field Therapy ; Osteoporosis, Postmenopausal ; therapy

BACKGROUNDGenetic factors are important in the pathogenesis of osteoporosis, but less is known about the genetic determinants of osteoporosis treatment. We aimed to explore the association between the gene polymorphisms of key enzyme farnesyl diphosphate synthase (FDPS) in mevalonate signaling pathway of osteoclast and response to alendronate therapy in osteoporotic postmenopausal women in China.

METHODSThe study group comprised 639 postmenopausal women aged (62.2 ± 7.0) years with osteoporosis or osteopenia who had been randomly assigned to low dose group (70 mg/2 w) or standard dose group (70 mg/w) of alendronate in this 1-year study. We identified allelic variant of the FDPS gene using the polymerase chain reaction and restriction enzyme Faul. Before and after treatment, serum levels of calcium, phosphate, alkaline phosphatase (ALP), cross linked C-telopeptide of type I collagen (β-CTX) were detected. Bone mineral density (BMD) at lumbar spine and proximal femur was measured. The association was analyzed between the polymorphisms of FDPS gene and the changes of BMD, bone turnover biomarkers after the treatment.

RESULTSThe FDPS rs2297480 polymorphisms were associated with baseline BMD at femoral neck, and patients with CC genotype had significantly higher baseline femoral neck BMD ((733.6 ± 84.1) mg/cm(2)) than those with AC genotypes ((703.0 ± 86.9) mg/cm(2)) and AA genotypes ((649.8 ± 62.4) mg/cm(2)) (P < 0.01). No significant difference in BMD at lumbar spine was observed among different genotypes of FDPS. The percentage change of serum ALP level was significantly lower in patients with CC genotype (-22.9%) than that in those with AC genotype (-24.1%) and AA genotype (-29.8%) of FDPS after 12 months of alendronate treatment (P < 0.05). Neither percentage change of BMD nor β-CTX level after alendronate treatment had association with FDPS genotype.

CONCLUSIONSFDPS gene was probably a candidate gene to predict femoral neck BMD at baseline. FDPS gene alleles could predict change percentage of ALP after treatment of alendronate, but possibly had no significant relationship with the responsiveness of BMD to alendronate therapy.

Alendronate ; therapeutic use ; Asian Continental Ancestry Group ; Bone Density Conservation Agents ; therapeutic use ; Female ; Geranyltranstransferase ; genetics ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal ; drug therapy ; genetics ; Polymorphism, Genetic

OBJECTIVE: To evaluate quality of life (QOL) in the treatment assessment of postmenopausal osteoporosis (PMOP) by comparing the QOL of three treatments: hormone replacement treatment, supplement of calcium and vitamin D and risedronate. METHODS: All patients with postmenopausal osteoporosis (PMOP) in this clinical trial had been allocated into 4 groups: placebo therapy group, vitamin D addition calcium therapy group, hormone replacement treatment (HRT) therapy group, and risedronate therapy group. We measured the bone mineral density (BMD) and quality of life sale (QOLS) of patients in three times, before the treatment, 3 months after the treatment,and 12 months after the treatment. The differences of the QOL and BMD at the 4 groups and at different time, the linear correlation of the change of QOL and the change of BMD, were both compared after the measurement. RESULTS: The total score of QOL and the score of disease domain and physical domain of HRT therapy group and risedronate therapy group were higher than the placebo therapy group (F = 17. 335, P <0.001), but vitamin D addition calcium therapy group was not different from that of the placebo therapy group. The score of other three domains had no statistically significant difference among the 4 groups. The score of disease domain of the patients of risedronate therapy group started to increase after 3 months of treatment, and continued to increase after 12 months of treatment. The score of disease domain of the patients of HRT therapy group started to increase only after 12 months of treatment. But the score of disease domain of the patients of vitamin D addition calcium therapy group did not increase after 12 months of treatment. The changes of the score of disease domain had the linar correlation with the changes of BMD, and the correlation coefficient was from 0.608 to 0.827. CONCLUSION QOL may become one of the indexes of medical treatment outcome assessment system for PMOP.
Absorptiometry, Photon ; Alendronate ; therapeutic use ; Estrogen Replacement Therapy ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal ; drug therapy ; psychology ; Quality of Life ; Vitamin D ; therapeutic use

OBJECTIVE: To study and compare the clinical effects of Rehmannia Decoction and alendronate sodium for the treatment of primary osteoporosis. METHODS: From January 2016 to December 2017, 72 patients with primary osteoporosis who took Dihuang Decoction(DHD) orally and alendronate regularly for more than one year were randomly divided into 2 groups:experimental group and control group. The experimental group consisted of 14 males and 22 females, with an average age of(63.97±3.70) years old. The patients in the experimental group took Chinese medicine DHD, one dose each time, one time in the morning and one time in the evening, twice a week. The control group consisted of 16 males and 20 females with an average age of(63.36±3.07) years old. Patients in the control group were given alendronate 70 mg orally once a week. The basic treatment for osteoporosis remained unchanged in both groups(600 mg of calcium carbonate D3 and 0.5 μg of calcitriol capsules were taken daily). Bone mineral density (BMD) of femoral neck and lumbar vertebrae was measured by dual energy X-ray absorptiometry before and after treatment for one year. The levels of serum collagen type I C-terminal peptide (beta-CTX) and serum osteoclast (SOST) were measured before and after treatment for two groups. RESULTS: The age, bone mineral density, SOST and beta-CTX baseline values between the two groups before and after anti-osteoporosis treatment were compared. The difference was not statistically significant(>0.05). Compared with the two groups, the BMD of femoral neck and lumbar vertebrae were increased after 1 year of anti-osteoporosis treatment. The differences were statistically significant (<0.001). The value of serum beta-CTX was significantly lower than before. The values were 52.002 and 50.071 respectively. The value of serum SOST was increased than that before treatment. The values were -29.242 and -30.807 respectively. The differences were statistically significant (<0.001). BMD of the femoral neck and lumbar spine was compared between the two groups after treatment. The P values were 0.294 and 0.478 respectively. The difference was not statistically significant (>0.05). The serum beta-CTX values were compared between the two groups after treatment. The value was 0.908. The serum SOST values were compared between the two groups after treatment. The value was 0.888. The difference was not statistically significant (>0.05). CONCLUSIONS In this study, traditional Chinese medicine DHD is used to treat osteoporosis. It is found that DHD and alendronate have a good effect. The DHD can be used as a choice of Chinese medicine in the treatment of primary osteoporosis.
Absorptiometry, Photon ; Aged ; Alendronate ; therapeutic use ; Bone Density ; Bone Density Conservation Agents ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Osteoporosis ; drug therapy

OBJECTIVE: To determine the effect of alendronate on glucocorticoid-induced osteoporosis(GIO). METHODS: Thirty-five GIO patients were enrolled. Ten milligrams alendronate were prescribed daily for 6 months. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometer (DEXA) after and before the treatment. RESULTS: BMD at lumbar, neck and trochanter sites of the 35 patients after the treatment was significantly increased compared with those before the treatment (P<0.05). Urine Ca/Cr level was decreased (P<0.05). There was no severe side effect. CONCLUSION Alendronate is effective and well tolerated for GIO.
Adult ; Alendronate ; therapeutic use ; Bone Density ; drug effects ; Bone Density Conservation Agents ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Osteoporosis ; chemically induced ; drug therapy ; Prednisone ; adverse effects ; therapeutic use ; Rheumatic Fever ; drug therapy

OBJECTIVETo evaluate the efficacy and safety of alendronate for the treatment of osteoporosis/osteopenia secondary to hyperthyroidism.

METHODSFrom April 2008 to November 2009, 27 patients with hyperthyroidism with osteoporosis/ osteopenia measured by dual energy X-ray absorptiometry (DXA) were included in this study, and then they were randomly divided into two groups (group A and group B) by simple random sampling. Group A consisted of 14 patients treated with antithyroid drug and caltrate D, the antithyroid drug change with thyroid function, and caltrate D 600 mg per day. Group B consisted of 13 patients treated with antithyroid drug, caltrate D and alendronate, antithyroid drug and caltrate D the same as group A, and alendronate 70 mg weekly. Meanwhile, 21 healthy voluntary adults were chosen as control group. And compared with the control group which was treated with nothing. Followed-up for one year, the bone mineral density (including T-score, Z-score, BMD) in lumbar spine (LS), femoral neck (FN) and distal radius (DR) and general information, were compared before and after treatment.

RESULTSBMD at FN and DR were significantly higher at 12 months after treatment than at the baseline in group A (P = 0.000); T-score, Z-score, and BMD at the LS, FN and DR were all significantly higher at 12 months after treatment than at the baseline in group B (P < 0.05), but these data could not arrive to normal level. In group A, the percentage increased in BMD at the LS, FN, and DR were (4.34 +/- 10.5)%, (3.21 +/- 1.38)%, (1.95 +/- 0.44)%, respectively, at 12 months after treatment. In group B, the percentage increased in BMD at the LS, FN, and DR were (6.10 +/- 8.12)%, (4.10 +/- 5.64)%, (3.10 +/- 3.23)%, respectively, at 12 months after treatment. There was significant difference in the rate of increase between two groups (P < 0.05). AKP decreased, weight, BMI increased, and thyroid function decreased, after treatment than those before in both of the two groups. (P < 0.05).

CONCLUSIONAlendronate can significantly increase BMD in treating patients with hyperthyroidism and osteoporosis/osteopenia. Compared with anti-thyroid drugs alone, treatment with alendronate can obtain more clinical effect and also very safety.

Adult ; Alendronate ; therapeutic use ; Bone Density ; Bone Density Conservation Agents ; therapeutic use ; Bone Diseases, Metabolic ; drug therapy ; etiology ; Female ; Humans ; Hyperthyroidism ; complications ; drug therapy ; Male ; Middle Aged ; Osteoporosis ; drug therapy ; etiology