-
1.
Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms.
Scheinberg, M, Pott Júnior, H, Macêdo, EA, Bocchi de Oliveira, MF, Ecclissato, C, Amazonas, RB
Drug design, development and therapy. 2018;:2775-2783
Abstract
PURPOSE This study investigated the safety and efficacy of fixed-dose combination tablets of naproxen/esomeprazole magnesium and nimesulide/pantoprazole to determine if both regimens are equally suited to relieve pain in patients with osteoarticular diseases and dyspeptic symptoms. METHODS Patients were randomly assigned to receive either nimesulide/pantoprazole (100 mg/20 mg) twice daily or naproxen/esomeprazole magnesium (500 mg/20 mg) twice daily for 14 days. The primary endpoint was defined as the mean change in modified Western Ontario and McMaster Universities Osteoarthritis Index pain subscale. Secondary endpoints were mean visual analog scale score of dyspeptic symptoms (nausea, abdominal discomfort/pain, epigastric burning, postprandial fullness), mean visual analog scale score of individual dyspeptic symptoms, and individual score of dyspeptic symptoms according to patient diary. This study is registered at ClinicalTrials.gov: NCT01670552. RESULTS A total of 490 patients were enrolled and randomized, and 399 completed treatment (naproxen/esomeprazole, n=201; nimesulide/pantoprazole, n=198). The difference in mean change in the modified Western Ontario and McMaster Universities Osteoarthritis Index pain score after 7 days of treatment between the two treatment groups was 2.33 mm (95% CI, -1.22 to 5.89 mm). After 14 days of therapy, the difference was 0.45 mm (95% CI, -3.29 to 4.19 mm). The most common adverse events in the pooled group were abdominal discomfort, abdominal distention, dyspepsia, and nausea, but none of these was deemed to be clinically meaningful. CONCLUSION The present study demonstrated noninferiority of a 14-day regimen with a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for the treatment of osteoarticular pain.
-
2.
Oligosaccharide nanomedicine of alginate sodium improves therapeutic results of posterior lumbar interbody fusion with cages for degenerative lumbar disease in osteoporosis patients by downregulating serum miR-155.
Qu, Y, Wang, Z, Zhou, H, Kang, M, Dong, R, Zhao, J
International journal of nanomedicine. 2017;:8459-8469
Abstract
Degenerative lumbar disease (DLD) is a significant issue for public health. Posterior lumbar intervertebral fusion with cages (PLIFC) has high-level fusion rate and realignment on DLD. However, there are some complications following the surgery. Alginate oligosaccharides (AOS) have antioxidant and anti-inflammatory activities and may be suitable for infection therapy. MiR-155 is a biomarker associated with inflammatory and oxidative stress. AOS may promote PLIFC therapy by regulating miR-155. Pluronic nanoparticles and oligosaccharide nanomedicine of alginate sodium (ONAS) were prepared with ampicillin at size <200 nm. Ninety-six DLD osteoporosis patients received PLIFC and were evenly assigned into ONAS group (OG, oral administration of 100 mg ONAS daily) and control group (PG, 100 mg pluronic nanoparticles). Serum miR-155 level was measured by real-time quantitative PCR. The levels of superoxide dismutase (SOD), glutathione (GSH), aspartate aminotransaminase (AST), alanine aminotransferase (ALT), interleukin-1β (IL-1β), and interleukin-1 receptor antagonist (IL-1ra) were measured. Weighted mean difference (WMD), relative risk (RR), complications, surgery infection rate, fusion rate, and Japanese Orthopaedic Association (JOA) scores were used to evaluate therapeutic efficacy. After 1-month therapy, infection rates and side effects were lower in OG than those in PG (RR =0.64, 95% confidence interval [CI] [0.48, 0.84], P=0.001). The fusion rates were higher in OG than in PG (WMD =21.96, 95% CI [-0.24, 37.62], P=0.021). The JOA scores were higher in OG than in PG (RR =0.52, 95% CI [0.33, 0.84], P=0.007), and no significant difference was found for the visual analog scale and Oswestry Disability Index. Serum levels of miR-155, ALT, AST, and IL-1β were lower while SOD, GSH, and IL-1ra were higher in OG than in PG. MiR-155 mimic increased the levels of ALT, AST, and IL-1β and reduced the levels of SOD, GSH, and IL-1ra. In contrast, miR-155 inhibitor had reverse results. Therefore, ONAS has better improvement in complications and therapeutic effects on DLD by regulating serum miR-155.
-
3.
ACTN3 Gene and Susceptibility to Sarcopenia and Osteoporotic Status in Older Korean Adults.
Cho, J, Lee, I, Kang, H
BioMed research international. 2017;:4239648
Abstract
BACKGROUND Little information is available about molecular markers for sarcopenia and osteoporosis in Asian populations. OBJECTIVE This study investigated the association of the ACTN3 polymorphism with sarcopenia and osteoporotic status in older Korean adults. METHODS Older Korean 62 men and 270 women (mean age 73.7 ± 6.6 years) participated in this study. Body mass index, percent body fatness, appendicular skeletal muscle mass, and bone mineral density of the lumbar spine, femur, and total body were analyzed with dual-energy X-ray absorptiometry. ACTN3 R/X genotyping was determined using TaqMan probes. RESULTS Determination of odds ratios (ORs) and 95% confidence intervals (CIs) using binary logistic regression analyses showed that XX homozygotes were at a significantly higher risk of sarcopenia (OR = 2.056, 95% CI = 1.024-4.127, p = 0.043) and osteoporosis (OR = 2.794, 95% CI = 1.208-5.461, p = 0.016) than RR homozygotes (reference group, OR = 1). The OR of XX homozygotes for having sarcopenia remained significant (OR = 2.237, 95% CI = 1.044-4.836, p = 0.038) after adjustments for age, gender, body fatness, and serum vitamin D. The OR of XX homozygotes for having osteoporosis was no longer significant (OR = 2.682, 95% CI = 0.960-7.942, p = 0.075) after adjustments for the covariates. CONCLUSION Our findings suggest that the ACTN3 R577X genotype may influence decline in muscle and bone health phenotypes in older Korean adults.
-
4.
Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation.
Yamamoto, T, Tsujimoto, M, Sowa, H
Clinical interventions in aging. 2015;:1101-9
Abstract
OBJECTIVE Serum procollagen type I N-terminal propeptide (PINP), a representative marker of bone anabolic action, is strongly related to bone mineral density during teriparatide therapy. This post hoc study analyzed data from a Phase III study (ClinicalTrials.gov identifier NCT00433160) to determine if there was an association between serum PINP elevation and serum calcium concentration or calcium metabolism-related disorders. RESEARCH DESIGN AND METHODS Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects. MAIN OUTCOME MEASURES Serum PINP levels were measured at baseline, and after 1, 3, 6, 12, 18, and 24 months of treatment. Serum calcium levels were measured at baseline, and after 1, 3, 6, 9, 12, 15, 18, 21, and 24 months of treatment. RESULTS Serum PINP increased from baseline to 1 month of treatment and then remained high through 24 months. Twenty-eight of 195 subjects experienced PINP elevations >200 μg/L during teriparatide treatment. Serum calcium concentration in both the teriparatide and placebo groups remained within the normal range. There was no clinically relevant difference in serum calcium concentration between subjects with PINP >200 μg/L and subjects with PINP ≤200 μg/L. Two subjects experienced hypercalcemia and recovered without altering teriparatide treatment. Adverse events possibly related to calcium metabolism disorders included periarthritis calcarea (one subject) and chondrocalcinosis pyrophosphate (two subjects), but neither was accompanied with a significant increase in PINP or serum calcium concentration. CONCLUSION Although the moderate size of this study prevented statistical analysis of any potential association between calcium metabolism-related disorders and elevated PINP, this analysis suggests that there was no association between serum PINP elevation during daily teriparatide treatment and serum calcium concentration or calcium metabolism-related disorders in Japanese subjects.
-
5.
The effect of a prevention program based on health belief model on osteoporosis.
Khani Jeihooni, A, Hidarnia, A, Kaveh, MH, Hajizadeh, E
Journal of research in health sciences. 2015;(1):47-53
Abstract
BACKGROUND Osteoporosis is one of the most common metabolic bone diseases. The purpose of this study was to investigate the effect of a prevention program based on health belief model on osteoporosis among women. METHODS In this quasi-case study, 120 patients (60 cases and 60 control), registered under the health centers in Fasa City, Fars Province, Iran were selected in 2014. A questionnaire consisting of demographic information, Health Belief Model (HBM) constructs was used to measure nutrition and walking performance for prevention of osteoporosis before, immediately after the intervention and six months later. Bone mineral density (BMD) was recorded at the lumbar spine and femur before and six months after intervention. Data were analyzed using SPSS19 via chi-square test, independent t-test, and Repeated Measures ANOVA at significance level of 0.05. RESULTS Immediately and six months after the intervention, the case group showed a significant increase in the knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, internal cues to action, nutrition and walking performance compared to the control group. Six months after the intervention, the value of lumbar spine BMD T-Score in the case group increased to 0.127, while in the control group it reduced to -0.043. The value of the Hip BMD T-Score in the intervention group increased to 0.125 but it decreased to -0.028 in the control group. CONCLUSIONS This study showed the effectiveness of knowledge, walking and diet on bone mass by HBM model. Hence, these models can act as a framework for designing and implementing educational interventions for the osteoporosis prevention.
-
6.
A phase IV, two-armed, randomized, cross-over study comparing compliance with once-a-month administration of vitamin D3 to compliance with daily administration of a fixed-dose combination of vitamin D3 and calcium during two 6-month periods.
Bruyère, O, Deroisy, R, Dardenne, N, Cavalier, E, Coffiner, M, Da Silva, S, De Niet, S, Reginster, JY
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2015;(12):2863-8
-
-
Free full text
-
Abstract
UNLABELLED In a randomized, cross-over study, once monthly administration of vitamin D3 was preferred over a once daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels. INTRODUCTION The aim of the present study was to compare a once-monthly administration of vitamin D3 to a daily administration of a fixed-dose combination of vitamin D3 and calcium during two treatment periods of 6 months. METHODS One hundred volunteers aged 50 years old or older were randomized to receive either one drinkable ampoule containing 25,000 IU vitamin D3 (D-Cure®, SMB) once monthly (group VD) or one chewable tablet containing 1000 mg calcium carbonate + 800 IU vitamin D3 (Steovit Forte®, Takeda) once daily (group VDCa) during 6 months. After the first 6 months of treatment, the groups were reversed according to the randomized cross-over design. Treatment compliance (i.e. the primary outcome), preference, acceptability and vitamin D levels and adverse events were all collected. RESULTS For the two periods, the patients had a significantly higher compliance in the VD group than in the VDCa group (p < 0.0001). During the study, 50 (56.8 %) patients preferred the VD treatment, 16 (18.2 %) patients preferred the VDCa, and for 22 (25.0 %) patients, neither treatment was preferred. At the end of the first 6 months of treatment, the mean (SD) increase of 25(OH)D was 6.57 ng/mL (8.19) in the VD group and 3.88 ng/mL (10.0) in the VDCa group (p = 0.16 between groups). CONCLUSION In this study, a once-monthly administration of vitamin D3 was preferred over a once-daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels.
-
7.
Bioceramic vertebral augmentation with a calcium sulphate/hydroxyapatite composite (Cerament SpineSupport): in vertebral compression fractures due to osteoporosis.
Rauschmann, M, Vogl, T, Verheyden, A, Pflugmacher, R, Werba, T, Schmidt, S, Hierholzer, J
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2010;(6):887-92
-
-
Free full text
-
Abstract
A prospective, non-randomized multicenter study was initiated to study efficacy and safety of a partly resorbable composite of calcium sulphate and hydroxyapatite (Cerament SpineSupport), a novel, injectable bioceramic, in osteoporotic patients with vertebral compression fractures during 18-month follow-up. Fifteen patients with low-energy trauma and 1-2 vertebral compression fractures verified by magnetic resonance imaging were recruited to undergo percutaneous bioceramic vertebral augmentation under fluoroscopy. The patients were treated with a highly flowable bioceramic containing calcium sulphate, hydroxyapatite and the non-ionic radiocontrast agent iohexol, with final setting time within 1 h. After the procedure, the patients were allowed to mobilize after 2 h. Pain (VAS), occurrence of remote and adjacent fractures, and Quality of Life (QoL; SF-36 and EQ-5D) was recorded during 18 months. The injected volume of the composite material ranged from 2.8 to 9 mL (mean 4.2 mL). Pre-operative VAS score was mean 70.3 (CI95% +/-8.7) with an immediate post-operative pain relief, which was maintained at the 4-week visit (mean 26.4 with CI95% +/-16.1) and 8-week visit (mean 18.0 with CI95% +/-13.5 pain relief). Eighty percent of the patients demonstrated a clinical improvement. The pain relief was maintained over 18 months and no adjacent fractures were observed. There was a statistically significant improvement of physical components in the QoL assessment. No extra-vertebral leakage or neurological deficits were reported in this series. This first prospective multicenter study on a partly resorbable bioceramic material indicate that fracture healing can be achieved with sustained pain relief over a follow-up period of 18 months in an osteoporotic patient population with vertebral compression fractures.
-
8.
Patient preference and acceptability of calcium plus vitamin D3 supplementation: a randomised, open, cross-over trial.
den Uyl, D, Geusens, PP, van Berkum, FN, Houben, HH, Jebbink, MC, Lems, WF
Clinical rheumatology. 2010;(5):465-72
-
-
Free full text
-
Abstract
UNLABELLED Preference for a drug formulation is important in adherence to long-term medication for chronic illnesses such as osteoporosis. We investigated the preference for and acceptability of chewable tablet containing calcium and vitamin D (Calci Chew D(3), Nycomed) compared to that of a sachet containing calcium and vitamin D(3) (Cad, Will-Pharma). This open, randomised, cross-over trial was set up to compare the preference and acceptability of two calcium plus vitamin D(3) formulations (both with 500 mg calcium and 400/440 IU vitamin D3), given twice a day in patients with osteoporosis. Preference and acceptability were assessed by means of questionnaires. Preference was determined by asking the question, which treatment the patient preferred, and acceptability was measured by scoring five variables, using rating scales. Of the 102 patients indicating a preference for a trial medication, 67% preferred the chewable tablet, 19% the sachet with calcium and vitamin D(3,) and 15% stated no preference. The significant preference for Calci Chew D(3) (p < 0.0001) was associated with higher scores for all five acceptability variables. The two formulations were tolerated equally well. A significant greater number of patients considered the chewable tablet as preferable and acceptable to the sachet, containing calcium and vitamin D(3). TRIAL REGISTRATION Current Controlled Trials ISRCTN18822358.
-
9.
Additional beneficial effects of recombinant growth hormone in alendronate-treated patients with idiopathic osteoporosis.
Lopes, RF, Coeli, CM, Vaisman, M, de Farias, ML
Endocrine journal. 2009;(7):851-8
-
-
Free full text
-
Abstract
In order to study the benefit of adding recombinant human growth hormone (rhGH) to antiresorptive therapy, six patients with idiopathic osteoporosis (IO) receiving alendronate plus calcium and vitamin D were started on daily subcutaneous injections of rhGH 2.0 IU for one year. Fasting morning urine and serum samples were collected for N telopeptide of type-1 collagen (NTX), serum bone-specific alkaline phosphatase (BSAP) and insulin-like growth factor 1 (IGF-1) during the study. Bone mineral density (BMD) was determined by dual-energy x-ray absorptiometry at baseline and 01 year. The effect of rhGH was evaluated comparing the percentage changes in BMD during the last year on ALN with the results obtained with the combined therapy. Serum IGF-1 increased in all patients but variations were not significant (p=0.266). Serum BSAP did not significantly change (p=0.078) but median NTX increased at 45 days from 12.3 to 19.8 nMBCE/mMCr (p=0.012) and tended to return to baseline values at 12 months (15.2 nMBCE/mMCr). Comparing with isolated ALN therapy, a beneficial effect on bone density was observed in 2/3 of the patients at lumbar spine, and percentage change (median and quartiles) varied from -0.65% (-2.33 and 2.23) on ALN to 0.70% (-0.35 and 3.03) on ALN+GH. Although no bone gain occurred at the femoral neck, our data point to a positive effect of rhGH in patients with idiopathic osteoporosis.
-
10.
Treatment of painful vertebral fractures by kyphoplasty in patients with primary osteoporosis: a prospective nonrandomized controlled study.
Kasperk, C, Hillmeier, J, Nöldge, G, Grafe, IA, Dafonseca, K, Raupp, D, Bardenheuer, H, Libicher, M, Liegibel, UM, Sommer, U, et al
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2005;(4):604-12
-
-
Free full text
-
Abstract
UNLABELLED This study investigates the effects of kyphoplasty on pain and mobility in patients with osteoporosis and painful vertebral fractures compared with conventional medical management. INTRODUCTION Pharmacological treatment of patients with primary osteoporosis does not prevent pain and impaired activity of patients with painful vertebral fractures. Therefore, we evaluated the clinical outcome after kyphoplasty in patients with vertebral fractures and associated chronic pain for >12 months. MATERIALS AND METHODS Sixty patients with primary osteoporosis and painful vertebral fractures presenting for >12 months were included in this prospective, nonrandomized controlled study. Twenty-four hours before performing kyphoplasty, the patients self-determined their inclusion into the kyphoplasty or control group so that 40 patients were treated with kyphoplasty, whereas 20 served as controls. This study assessed changes in radiomorphology, pain visual analog scale (VAS) score, daily activities (European Vertebral Osteoporosis Study [EVOS] score), number of new vertebral fractures, and health care use. Outcomes were assessed before treatment and at 3 and 6 months of follow-up. All patients received standard medical treatment (1g calcium, 1000 IE vitamin D(3), standard dose of oral aminobisphosphonate, pain medication, physical therapy). RESULTS Kyphoplasty increased midline vertebral height of the treated vertebral bodies by 12.1%, whereas in the control group, vertebral height decreased by 8.2% (p = 0.001). Augmentation and internal stabilization by kyphoplasty resulted in a reduction of back pain. VAS pain scores improved in the kyphoplasty group from 26.2 +/- 2 to 44.2 +/- 3.3 (SD; p = 0.007) and in the control group from 33.6 +/- 4.1 to 35.6 +/- 4.1 (not significant), whereas the EVOS score increased in the kyphoplasty group from 43.8 +/- 2.4 to 54.5 +/- 2.7 (p = 0.031) and in the control group from 39.8 +/- 4.5 to 43.8 +/- 4.6 (not significant). The number of back pain-related doctor visits within the 6-month follow-up period decreased significantly after kyphoplasty compared with controls: mean of 3.3 visits/patient in the kyphoplasty group and a mean of 8.6 visits/patient in the control group (p = 0.0147). CONCLUSIONS The results of this study show significantly increased vertebral height, reduced pain, and improved mobility in patients after kyphoplasty. Kyphoplasty performed in appropriately selected osteoporotic patients with painful vertebral fractures is a promising addition to current medical treatment.