-
1.
Analysis of the Mechanism and Safety of Bisphosphonates in Patients with Lung Cancer and Bone Metastases.
Zhang, G, Gong, H, Xu, H
Computational and mathematical methods in medicine. 2021;:5343104
Abstract
OBJECTIVE To explore the mechanism and safety of bisphosphonates in patients with lung cancer and bone metastases. METHOD A total of 104 patients with lung cancer and bone metastases in our hospital were selected and randomly divided into two groups: control group (n = 54) and research group (n = 50). Chemotherapy was given to the control group, and the research group was treated with bisphosphonate drugs. The quality of life, HAMA, HAMD score, VAS score, treatment effect, serum calcium and KPS score, inflammatory factor levels, and immune function were compared between the two groups. RESULT The quality of life in both groups was significantly increased (P < 0.05). The HAMA and HAMD scores of the research group decreased significantly than those of the control group after treatment (P < 0.05). The VAS scores of the two groups were significantly reduced (P < 0.05). The effective rates of treatment in the control group and the research group were 81.5% and 96.0%, respectively. Serum calcium was significantly decreased, and KPS score was significantly increased at weeks 1 and 6 after treatment, and the change was more obvious in the research group (P < 0.05). The levels of inflammatory factors in the two groups were significantly reduced, and the immune indicators were significantly increased. CONCLUSION Bisphosphonates have good effect on patients with lung cancer and bone metastases, which can improve anxiety and depression, reduce pain score, improve serum calcium level and immune function, and reduce inflammatory response. Therefore, bisphosphonate drug therapy is worth widely used.
-
2.
Monthly Oral Ibandronate Reduces Bone Loss in Korean Women With Rheumatoid Arthritis and Osteopenia Receiving Long-term Glucocorticoids: A 48-week Double-blinded Randomized Placebo-controlled Investigator-initiated Trial.
Shin, K, Park, SH, Park, W, Baek, HJ, Lee, YJ, Kang, SW, Choe, JY, Yoo, WH, Park, YB, Song, JS, et al
Clinical therapeutics. 2017;(2):268-278.e2
Abstract
PURPOSE Our aim was to investigate the efficacy of monthly oral ibandronate in Korean women with rheumatoid arthritis and reduced bone mineral density (BMD) receiving long-term glucocorticoids. METHODS Patients (n = 167 women) were randomly assigned (1:1) to receive ibandronate 150 mg or placebo every 4 weeks. Patients had taken glucocorticoid (equivalent of daily prednisolone ≥5 mg) for 3 or more consecutive months before enrollment, and had a lumbar spine 1 to 4 (L1-L4) T-score of < -1.0 and ≥ -2.5. Both groups were provided with daily calcium carbonate and cholecalciferol. The primary end point was the L1 to L4 BMD percent changes at 48 weeks compared with baseline. FINDINGS Baseline characteristics were comparable between the 2 groups. BMD percent changes in L1 to L4 at 48 weeks were significantly different between the ibandronate versus the placebo group (+3.7% [5.1%] vs -1.9% [4.4%], respectively; P < 0.0001). BMD percent changes at 48 weeks in femur neck and total hip also had similar results (P = 0.0073 and P = 0.0031, respectively). Decrease of serum type 1 collagen C-terminal telopeptide was significant at both 24 and 48 weeks in the ibandronate group. There was no incident of fragility fracture in both groups during the study period. Safety profiles, including adverse events, were comparable between the 2 groups. IMPLICATIONS Monthly oral ibandronate for 48 weeks is well tolerated and effective in reducing bone mineral loss in women with rheumatoid arthritis on long-term glucocorticoid therapy. Longer follow-up studies are needed to investigate the benefit of ibandronate on fracture rate reduction in this subset of patients. ClinicalTrials.gov identifier: NCT01287533.
-
3.
Effect of bisphosphonate initiation at week 2 versus week 12 on short-term functional recovery after femoral neck fracture: a randomized controlled trial.
Unnanuntana, A, Laohaprasitiporn, P, Jarusriwanna, A
Archives of osteoporosis. 2017;(1):27
-
-
Free full text
-
Abstract
UNLABELLED The appropriate time to initiate bisphosphonate treatment after a fragility fracture has not yet been established. In this study, we found no significant differences in short-term functional recovery between femoral neck fracture patients who received bisphosphonate treatment at 2 versus 12 weeks after hemiarthroplasty. INTRODUCTION Bisphosphonate is the mainstay therapy for prevention and treatment of osteoporosis. The aim of this study was to investigate the effect of bisphosphonate initiation on short-term functional recovery in femoral neck fracture patients at 2 versus 12 weeks after hemiarthroplasty. METHODS One hundred patients were randomly allocated into two groups in a parallel group designed, randomized, controlled trial. Both groups received risedronate 35 mg/week at either 2 or 12 weeks after hemiarthroplasty. All patients received calcium and vitamin D supplementation. Functional recovery was assessed by de Morton Mobility Index, Barthel Index, EuroQol 5D, visual analog scale, 2-min walk test, and timed get-up-and-go test at 2 weeks, 3 months, and 1 year after surgery. RESULTS At the 3-month follow-up, all functional outcome measures showed significant improvement in both groups. There were no statistically significant differences in any of the functional outcomes between groups at both the 3-month and 1-year follow-ups. Although patients who received bisphosphonate initiation at week 2 had lower serum calcium level at 3 months and more overall adverse events than patients in the week 12 group, no patients in either group discontinued their prescribed medications. CONCLUSIONS While underpowered, the findings of this study suggest that there were no significant differences in short-term functional recovery or significant adverse events between the two bisphosphonate groups. Thus, the initiation of bisphosphonate therapy may be considered as early as 2 weeks after femoral neck fracture. It is important that low serum calcium and vitamin D status must be corrected with calcium and vitamin D supplementation prior to or at the time of bisphosphonate initiation. CLINICAL TRIAL REGISTRATION NUMBER This study was registered in the database via the Protocol Registration and Results System (PRS) (NCT02148848).
-
4.
Effectiveness of monotherapy and combined therapy with calcitonin and minodronic acid hydrate, a bisphosphonate, for early treatment in patients with new vertebral fractures: An open-label, randomized, parallel-group study.
Tanaka, S, Yoshida, A, Kono, S, Ito, M
Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association. 2017;(3):536-541
Abstract
BACKGROUND Evidence related to the effectiveness of combination drug therapy for the treatment of osteoporosis is currently considered insufficient. Therefore, this study was performed to clarify the effects of monotherapy, and combination therapy, with a bisphosphonate (minodronic acid hydrate), a bone resorption inhibitor, and calcitonin (elcatonin), which is effective for the alleviation of pain due to vertebral fractures in osteoporotic patients. METHODS Study participants comprised of 51 female subjects with post-menopausal osteoporosis, whose main complaint was acute lower back pain caused by vertebral fractures. Subjects were randomly allocated into three groups and then administered with either intramuscular injections of elcatonin at a dose of 20 units weekly, minodronic acid hydrate at a dose of 1 mg daily, or a combination of these two drugs. As primary endpoints, time-dependent changes in levels of pain were assessed using a visual analog scale from baseline to 6 months of duration. In addition, we examined the effects of monotherapies, and a combination therapy on bone resorption, with changes in bone mineral density at 4 sites and advanced hip assessment parameters from baseline to 6 months. A two-tailed significance level of 5% was used for hypothesis testing. RESULTS Elcatonin monotherapy showed some alleviation of pain immediately after any vertebral fractures, which was more than in the minodronic acid hydrate monotherapy group. In addition, the minodronic acid hydrate monotherapy group experienced more effective inhibited bone resorption than the elcatonin monotherapy group. In the combination therapy, the efficacy for alleviating pain and inhibiting bone resorption was equivalent to the effect observed in the elcatonin and minodronic acid hydrate monotherapy groups respectively, with further improved values of bone mineral density observed in the femoral neck and lumbar vertebrae, and in parameters of advanced hip assessment compared with both monotherapy groups. CONCLUSIONS Combination therapy with elcatonin and minodronic acid hydrate appears to be an effective treatment for osteoporosis patients with lower back pain, caused by fresh vertebral fractures.
-
5.
Higher response with bone mineral density increase with monthly injectable ibandronate 1 mg compared with oral risedronate in the MOVER study.
Nakano, T, Yamamoto, M, Hashimoto, J, Tobinai, M, Yoshida, S, Nakamura, T
Journal of bone and mineral metabolism. 2016;(6):678-684
Abstract
We examined response to bone mineral density (BMD) gains in the MOVER study following treatment with intravenous (IV) ibandronate 1 mg/month, and investigated the characteristics of a non-responder group. At 1 year, responder rates for patients with BMD increases >0 % were similar with IV ibandronate 0.5 or 1 mg/month and oral risedronate 2.5 mg/day. However, after 3 years, responder rates with BMD increases ≥3 % were highest with ibandronate 1 mg at all bone sites (>80 % at the lumbar spine [L2-L4] and >50 % at all femur sites, which was significantly higher than with risedronate). Non-responders were defined by BMD increases ≤3 % at L2-L4 or ≤0 % at total hip, and ≤50 % reduction in creatinine-corrected urinary collagen type 1 cross-linked C-telopeptide (uCTX) from baseline to 1 year. There were a small number of non-responders in the ibandronate 1 mg group: 3.3 % (10/299) with ≤0 % total hip BMD increase and ≤50 % uCTX reduction from baseline. These non-responders had lower 25-hydroxyvitamin D (25[OH]D) levels than responders, but no differences in kidney function, L2-L4 BMD or bone turnover marker baseline values. Throughout the study, non-responders failed to show any increases in BMD. Our analysis demonstrates significantly higher responder rates with IV ibandronate 1 mg/month than with risedronate at 3 years. A small number of non-responders in the ibandronate group had lower 25(OH)D baseline levels than responders, suggesting that 25(OH)D levels could be a useful indicator of BMD response to therapy.
-
6.
Effects of zoledronate on the radiation-induced collagen breakdown: a prospective randomized clinical trial.
Gierloff, M, Reutemann, M, Gülses, A, Niehoff, P, Wiltfang, J, Açil, Y
Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico. 2015;(6):454-61
Abstract
BACKGROUND A negative side effect of therapeutic irradiation is the radiation-induced bone loss which can lead, in long term, to pathological fractures. Until today, the detailed mechanism is unknown. If osteoclasts would mainly contribute to the pathological bone loss, bisphosphonates could potentially counteract the osteolytic process and possibly help to prevent long-term complications. The aim of this study was to evaluate the effect of zoledronic acid on the early radiation-induced degradation of bone collagen fibrils by monitoring the urinary excretion of hydroxylysylpyridinoline and lysylpyridinoline under radiotherapy. PATIENTS AND METHODS A total of 40 patients with skeletal metastases were assigned for a local radiotherapy and bisphosphonate treatment. The patients were prospectively randomized into two treatment groups: group A (n = 20) received the first zoledronate administration after and group B (n = 20) prior to the radiotherapy. Urine samples were collected from each patient on the first day, in the middle, and on the last day of the radiation therapy. Measurement of the bone metabolites hydroxylysylpyridinoline and lysylpyridinoline was performed by high-performance liquid chromatography. Statistical analysis was performed using the Mann-Whitney U test. RESULTS The hydroxylysylpyridinoline and lysylpyridinoline excretion decreased significantly in the combined bisphosphonate and radiotherapy group (p = 0.02, p = 0.08). No significant change of the hydroxylysylpyridinoline and lysylpyridinoline excretion was determined in the patients that received solely irradiation. CONCLUSION The results indicate the ability of zoledronate to prevent the early radiation-induced bone collagen degradation suggesting that the radiation-induced bone loss is mainly caused by osteoclastic bone resorption rather than by a direct radiation-induced damage.
-
7.
Effects of protein-rich nutritional supplementation and bisphosphonates on body composition, handgrip strength and health-related quality of life after hip fracture: a 12-month randomized controlled study.
Flodin, L, Cederholm, T, Sääf, M, Samnegård, E, Ekström, W, Al-Ani, AN, Hedström, M
BMC geriatrics. 2015;:149
Abstract
BACKGROUND The catabolic state that follows hip fracture contributes to loss of muscle mass and strength, that is sarcopenia, which impacts functional ability and health-related quality of life. Measures to prevent such long-term postoperative consequences are of important concern. The aim of this study was to evaluate the combined effects of protein-rich nutritional supplementation and bisphosphonate on body composition, handgrip strength and health-related quality of life following hip fracture. METHODS The study included 79 men and women with hip fracture, mean age 79 years (SD 9), without severe cognitive impairment, who were ambulatory and living independently before fracture. Patients were randomized postoperatively to receive liquid supplementation that provided 40 g of protein and 600 kcal daily for six months after the fracture, in addition to bisphosphonates once weekly for 12 months (group N, n = 26), or bisphosphonates alone once weekly for 12 months (group B, n = 28). All patients, including the controls (group C, n = 25) received calcium 1 g and vitamin D3 800 IU daily. Body composition as measured by dual-energy X-ray absorptiometry (DXA), handgrip strength (HGS) and health-related quality of life (HRQoL) were registered at baseline, six and 12 months postoperatively. RESULTS There were no differences among the groups regarding change in fat-free mass index (FFMI), HGS, or HRQoL during the study year. Intra-group analyses showed improvement of HGS between baseline and six months in the N group (P = 0.04). HRQoL decreased during the first year in the C and B groups (P = 0.03 and P = 0.01, respectively) but not in the nutritional supplementation N group (P = 0.22). CONCLUSIONS Protein-rich nutritional supplementation was unable to preserve FFMI more effectively than vitamin D and calcium alone, or combined with bisphosphonate, in this relatively healthy group of hip fracture patients. However, trends toward positive effects on both HGS and HRQoL were observed following nutritional supplementation. TRIAL REGISTRATION Clinicaltrials.gov NCT01950169 (Date of registration 23 Sept 2013).
-
8.
Low-dose pamidronate for treatment of early bone loss following kidney transplantation: a randomized controlled trial.
Shahidi, S, Ashrafi, F, Mohammadi, M, Moeinzadeh, F, Atapour, A
Iranian journal of kidney diseases. 2015;(1):50-5
Abstract
INTRODUCTION Kidney transplantation is associated with rapid loss of bone mineral density (BMD) in the first months after transplantation. The effect of pamidronate on bone loss after transplantation was evaluated in a randomized controlled trial. MATERIALS AND METHODS Forty patients were enrolled in this study (16 in the pamidronate group and 24 in the control group). Pamidrinate was administered as 30-mg intravenous infusion within 2 days after transplantation and 3 months later. All of the patients received calcium and vitamin D supplementation. Laboratory parameters and BMD (lumbar spine and femoral neck) were measured at baseline and 6 months after kidney transplantation. RESULTS Bone mineral density at the initiation of study had no significant differences between the two groups. In each group, BMD of femoral neck and lumbar spine had no significant differences 6 months after transplantation in comparison to pretransplantation values. There was no significant difference in BMD changes after intervention between two groups. Parathyroid hormone level normalized in both of the pamidronate and control groups 6 months after kidney transplantation. Glomerular filtration rate at the end of study was not significantly different between the two groups. CONCLUSIONS Our study suggests that administration of calcium and vitamin D following transplantation may be beneficial to counterbalance the substantial bone loss occurring within 6 months after transplantation, and addition of pamidronate has no beneficial effect in BMD in this short interval after kidney transplantation.
-
9.
Comparison of two different strategies of treatment with zoledronate in HIV-infected patients with low bone mineral density: single dose versus two doses in 2 years.
Negredo, E, Bonjoch, A, Pérez-Álvarez, N, Ornelas, A, Puig, J, Herrero, C, Estany, C, del Río, L, di Gregorio, S, Echeverría, P, et al
HIV medicine. 2015;(7):441-8
-
-
Free full text
-
Abstract
OBJECTIVES Given the need for easily managed treatment of osteoporosis in HIV-infected patients, we evaluated the efficacy and tolerability of two doses of zoledronate, by comparing three groups of patients: those with annual administration, those with biennial administration (one dose in 2 years) and a control group with no administration of zoledronate. METHODS We randomized (2:1) 31 patients on antiretroviral therapy with low bone mineral density (BMD) to zoledronate (5 mg administered intravenously; 21 patients) plus diet counselling and to a control group (diet counselling; 10 patients). At week 48, patients treated with zoledronate were randomized again to receive a second dose (two-dose group; n = 12) or to continue with diet counselling only (single-dose group; n = 9). Changes in lumbar spine and hip BMD and bone turnover markers were compared. RESULTS The median percentage change from baseline to week 96 in L1-L4 BMD was -1.74% [interquartile range (IQR) -2.56, 3.60%], 7.90% (IQR 4.20, 16.57%) and 5.22% (IQR 2.02, 7.28%) in the control, two-dose and single-dose groups, respectively (P < 0.01, control vs. two doses; P = 0.02, control vs. single dose; P = 0.18, two doses vs. single dose). Hip BMD changed by a median of 2.12% (IQR -0.12, 3.08%), 5.16% (IQR 3.06, 6.74%) and 4.47% (IQR 1, 5.58%), respectively (P = 0.04, control vs. two doses; P = 0.34, two doses vs. single dose). No differences between the two-dose and single-dose groups were detected in bone markers at week 96. CONCLUSIONS The benefits for BMD of a single dose of zoledronate in 2 years may be comparable to those obtained with two doses of the drug after 96 weeks, although this study is insufficiently powered to exclude a real difference. Future studies should explore whether biennial administration of zoledronate is a useful alternative in the treatment of osteoporosis in HIV-infected patients.
-
10.
Multidetector-row computed tomography is useful to evaluate the therapeutic effects of bisphosphonates in glucocorticoid-induced osteoporosis.
Inoue, K, Hamano, T, Nango, N, Matsui, I, Tomida, K, Mikami, S, Fujii, N, Nakano, C, Obi, Y, Shimomura, A, et al
Journal of bone and mineral metabolism. 2014;(3):271-80
Abstract
Osteoporosis is one of the major complications of glucocorticoid therapy. Osteoporosis is usually defined by the levels of bone mineral density (BMD) assessed by dual energy X-ray absorptiometry (DEXA); however, glucocorticoids often induce fractures in patients with normal BMD. Thus, novel diagnostic approaches are required. In this study, we examined whether multidetector-row computed tomography (MDCT) is useful to assess the bone status in glucocorticoid-induced osteoporosis (GIO). Because bisphosphonates have been proven to prevent bone fracture in GIO, we tried to detect the therapeutic effects of bisphosphonates in GIO by MDCT. Fifteen Japanese patients with immunoglobulin A nephropathy who had normal renal function were enrolled in this open-label randomized trial. Patients were randomly divided into three groups-calcitriol (VD), menatetrenone (VK), or bisphosphonate (Bis). Bone conditions were analyzed twice by three different methods-bone turnover markers, DEXA, and MDCT-at the start and 6 months after the start of therapy. Both bone markers and DEXA could not detect significant differences among the therapeutic groups; however, MDCT-based analyses detected the preventive effects of bisphosphonates in GIO. Compared to VD, Bis improved structural indices, such as bone volume fraction, trabecular separation, marrow star volume, and structure model index whereas the difference between VD and VK was not significant. Finite element analysis revealed that simulated fracture load in the Bis group was significantly improved. These findings suggested that MDCT-based assessment is superior to bone markers and/or DEXA in assessing the therapeutic effect of bisphosphonates on GIO.