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1.
The effect of increasing dialysate magnesium on calciprotein particles, inflammation and bone markers: post hoc analysis from a randomized controlled clinical trial.
Bressendorff, I, Hansen, D, Pasch, A, Holt, SG, Schou, M, Brandi, L, Smith, ER
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2021;(4):713-721
Abstract
BACKGROUND The formation of calciprotein particles (CPPs) may be an important component of the humoral defences against ectopic calcification. Although magnesium (Mg) has been shown to delay the transition of amorphous calcium-/phosphate-containing primary CPP (CPP-1) to crystalline apatite-containing secondary CPP (CPP-2) ex vivo, effects on the endogenous CPP pool are unknown. METHODS We used post hoc analyses from a randomized double-blind parallel-group controlled clinical trial of 28 days treatment with high dialysate Mg of 2.0 mEq/L versus standard dialysate Mg of 1.0 mEq/L in 57 subjects undergoing maintenance hemodialysis for end-stage kidney disease. CPP load, markers of systemic inflammation and bone turnover were measured at baseline and follow-up. RESULTS After 28 days of treatment with high dialysate Mg, serum total CPP (-52%), CPP-1 (-42%) and CPP-2 (-68%) were lower in the high Mg group (all P < 0.001) but were unchanged in the standard dialysate Mg group. Tumour necrosis factor-α (-20%) and interleukin-6 (-22%) were also reduced with high dialysate Mg treatment (both P < 0.01). High dialysate Mg resulted in higher levels of bone-specific alkaline phosphatase (a marker of bone formation) (+17%) but lower levels of tartrate-resistant acid phosphatase 5 b (a marker of bone resorption; -33%) (both P < 0.01). Inflammatory cytokines and bone turnover markers were unchanged in the standard dialysate Mg group over the same period. CONCLUSIONS In this exploratory analysis, increasing dialysate Mg was associated with reduced CPP load and systemic inflammation and divergent changes in markers of bone formation and resorption.
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2.
The surgical management of the cavity and bone defects in enchondroma cases: A prospective randomized trial.
Nazarova, NZ, Umarova, GS, Vaiman, M, Asilova, SU, Abba, M, Foonberg, M, Shterenshis, M
Surgical oncology. 2021;:101565
Abstract
BACKGROUND We compared the curettage/bone grafting and the curettage/bone graft substitutes surgical techniques in their relation to functional outcomes, oncologic outcome (recurrence, malignant transformation), the rate of postsurgical complications, durations of surgery and of postsurgical immobilization for hand-localized cases of solitary and multiple enchondromas. METHODS The current prospective randomized trial analyzed 200 adult patients (2012-2017) with enchondroma who underwent surgical intervention. The cases were randomly divided into Group 1 (n = 100; F 56, M 44) for surgeries with curettage and autogenous bone grafting, and Group 2 (n = 100; F 55, M 45) for surgeries with curettage and bone graft substitutes. The placebo control Group 3 consisted of cases operated by curettage only (n = 56; F 31, M 25). The follow-up period was set at 30 months. RESULTS The duration of surgery was 51 ± 4 min in Group 1 and 27 ± 1 min in Group 2 (p = 0.008). In Group 1, the rate of recurrence was 6% against 1% in Group 2 (p = 0.005). No other statistically significant differences in postsurgical outcomes between three involved groups were noted. CONCLUSION In cases of enchondroma of the hand, postsurgical functional outcomes, the rate of postsurgical complications, the duration of immobilization, and the time to complete recovery are not influenced by the type of chosen grafting material. The implementation of HAp-collagen bone substitutes in granules instead of autogenous bone grafting reduces the duration of surgery. The implementation of autogenous bone grafting may increase the rate of tumor recurrence.
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3.
Comparable bone union progression after opening wedge high tibial osteotomy using allogenous bone chip or tri-calcium phosphate granule: a prospective randomized controlled trial.
Lee, DY, Lee, MC, Ha, CW, Kyung, HS, Kim, CW, Chang, MJ, Han, HS
Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA. 2019;(9):2945-2950
Abstract
PURPOSE The purpose of this study is to compare the progression rate of bone union and clinical outcomes of opening wedge high tibial osteotomy (OWHTO) using allogenous bone chip or tri-calcium phosphate (TCP) granule as bone graft materials. The hypothesis was that the bone union progression in OWHTOs using TCP granule grafts would be comparable to that of OWHTOs using allogenous bone chip grafts. METHODS Between 2011 and 2013, 54 patients who had undergone OWHTO for genu varum and osteoarthritis were randomized to one of the two groups at five centres. TCP granule was used to fill the defect in 27 patients and lyophilized allogenous bone chip was used in the other 27 patients. The degree of bone union was classified on a five-point scale and evaluated using plain radiographs of the knee at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, pain Visual Analogue Scale (VAS) score and complications were also evaluated. RESULTS The highest degree of bone union observed at 6 and 12 months postoperatively was grade 4, and the number of cases of union progression at each time-point was not significantly different between the two groups (p > 0.05). WOMAC and pain VAS scores also showed no differences between the two groups. No complications were observed during the 12-month period following OWHTO in either group. CONCLUSION OWHTO using TCP granule bone substitute showed similar bone union rates and clinical outcomes compared to allogenous bone chip grafts. TCP granule can be used as bone substitutes instead of allogenous bone chip grafts in OWHTO. LEVEL OF EVIDENCE Level 1.
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4.
Evaluation of the Efficacy of a 1:1 Mixture of β-TCP and rhPDGF-BB in the Surgical Management of Two- and Three-Wall Intraosseous Defects: A Prospective Clinical Trial.
Kavyamala, D, G, NVS, Dwarakanath, CD, Anudeep, M
The International journal of periodontics & restorative dentistry. 2019;(1):107-113
Abstract
The aim of this split-mouth clinical and radiographic study was to evaluate and compare the regenerative potential of a combination of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and beta tricalcium phosphate (β-TCP) to the established technique of bone grafting with β-TCP alone in the surgical management of intraosseous defects. A total of 24 sites in 12 subjects with intraosseous defects were included and randomly divided into test (rhPDGF-BB + β-TCP) and control (β-TCP alone) sites. Clinical parameters were recorded at baseline, 3 months, and 6 months. Radiographic parameters were evaluated at baseline and 6 months. Both groups showed statistically significant reductions of all clinical parameters. Intergroup comparison demonstrated a significantly greater probing pocket depth reduction and clinical attachment level gain in the test group. The mean percentage defect fill was significantly greater in the test group than in the control group at 3 and 6 months, and greater improvement in defect angle was also evident in the test group. Although both groups showed definitive improvements in all parameters, the test group showed significantly better results when used to treat human periodontal intraosseous defects.
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Recombinant Human Platelet-Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP)-Collagen Matrix as an Alternative to Autograft.
Daniels, TR, Anderson, J, Swords, MP, Maislin, G, Donahue, R, Pinsker, E, Quiton, JD
Foot & ankle international. 2019;(9):1068-1078
Abstract
BACKGROUND Joint arthrodesis often employs autograft to promote union; graft harvesting can lead to perioperative morbidity. A Canadian randomized controlled trial (RCT) demonstrated that recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) combined with beta-tricalcium phosphate (β-TCP)-collagen was a safe, effective alternative to autograft. This multicenter North American RCT compared the safety and efficacy of rhPDGF-BB/β-TCP-collagen with autograft for ankle and hindfoot fusion. Subclassification using propensity scores (PS) incorporated patients from previous trials for enhanced statistical power for noninferiority testing and broader review of treatments. METHODS Patients requiring ankle or hindfoot arthrodesis and supplemental bone graft were treated with rhPDGF-BB/β-TCP-collagen (n = 69) or autograft (n = 35). Outcomes included joint fusion on computed tomography (24 weeks), clinical healing status, visual analog scale (VAS) pain, Short-Form 12 (SF-12), American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale, and Foot Function Index (FFI) scores over 52 weeks. PS methodology addressed potential selection bias arising from pooling data among these patients and 2 previous RCTs with similar inclusion criteria, surgical techniques, graft harvest techniques, and outcomes. All 132 rhPDGF-BB/β-TCP-collagen-treated patients and 167 of 189 candidate autograft-treated controls were selected for comparison by an independent statistician blinded to outcomes. RESULTS In the PS subclassification, 68.1% treatment patients and 68.4% controls achieved >50% osseous bridging at fusion sites. Clinical healing status was achieved in 84.8% of treated patients and 90.7% of controls at 52 weeks. Clinical, functional, and quality of life results demonstrated noninferiority of rhPDGF-BB/β-TCP-collagen to autograft. Safety-related outcomes were equivalent. CONCLUSION PS subclassification analysis of 3 RCTs demonstrated that rhPDGF-BB/β-TCP-collagen was as effective as autograft for ankle and hindfoot fusions, with less pain and morbidity than treatment with autograft. LEVEL OF EVIDENCE Level I, prospective randomized study.
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6.
Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism of alendronate sodium/vitamin D3 combination in Chinese women with postmenopausal osteoporosis: a post hoc efficacy analysis and safety reappraisal.
Liao, EY, Zhang, ZL, Xia, WB, Lin, H, Cheng, Q, Wang, L, Hao, YQ, Chen, DC, Tang, H, Peng, YD, et al
BMC musculoskeletal disorders. 2018;(1):210
Abstract
BACKGROUND Vitamin D (VD) insufficiency or deficiency is a frequent comorbidity in Chinese women with postmenopausal osteoporosis (PMO). The present study aimed to investigate 25-hydroxyvitamin D [25(OH) D] improvement and calcium-phosphate metabolism in Chinese PMO patients treated with 70 mg of alendronate sodium and 5600 IU of vitamin D3 (ALN/D5600). METHODS Chinese PMO women (n = 219) were treated with 12-month ALN/D5600 (n = 111) or calcitriol (n = 108). Changes in 25(OH) D at month 12 were post hoc analyzed by the baseline 25 (OH) D status using the longitudinal analysis. The main safety outcome measures included serum calcium and phosphate and 24-h urine calcium, and the repeated measures mixed model was used to assess the frequencies of the calcium-phosphate metabolic disorders. RESULTS Absolute change in mean serum 25(OH) D level was the greatest in VD-deficient patients and least in VD-sufficient patients at months six and 12 (both, P < 0.01). Serum calcium level remained significantly lower in the ALN/D5600 treatment group than in the calcitriol treatment group throughout the 12 months. Mean 24-h urine calcium slightly increased in the ALN/D5600 treatment group and significantly increased in the calcitriol treatment group (+ 1.1 and + 0.9 mmol/L at months six and 12; both, P < 0.05). Calcitriol treatment was associated with more frequent hypercalciuria at month six (9.4% vs. 18.5%, P = 0.05), but not at month 12 (12.3% vs. 13.0%). CONCLUSION Baseline VD status predicted 25(OH) D improvement in PMO patients on 12-month ALN/D5600 treatment. The daily use of 0.25 μg of calcitriol was associated with more frequent hypercalciuria at month six, compared to ALN/5600 treatment, necessitating the safety re-evaluation of calcitriol at a higher dosage.
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7.
Randomized exploratory study to measure ion release from calcium sodium phosphosilicate-containing dentifrice.
Burnett, GR, Morrison, J, Whitworth, D, Hughes, AJ, Nehme, M, Sanyal, S, Brotherhood, AJ, Hall, PJ
European journal of oral sciences. 2018;(5):382-389
Abstract
This exploratory study investigated salivary concentrations of silicon, calcium, sodium, and phosphorous over a 60-min time period following the use of a calcium sodium phosphosilicate (CSPS)-containing dentifrice. Participants brushed with a dentifrice containing 5% (w/w) or 0% (w/w) CSPS or swilled with a slurry containing 5% (w/w) CSPS/glycerol. Saliva samples were collected before, and 2, 5, 15, and 60 min after, product use and were analysed using inductively coupled plasma optical emission spectroscopy. Intra-oral pH measurements were also taken. Primary analysis was of centrifuged saliva supernatant containing only dissolved material. At most time points, the CSPS-containing dentifrice and slurry generated significantly more salivary silicon than the dentifrice containing 0% CSPS. At 2-15 min after brushing there was significantly more salivary calcium after use of the CSPS-containing dentifrice and slurry, compared with the 0% CSPS dentifrice; a significant reduction, from baseline, in salivary calcium after use of dentifrice containing 0% CSPS; and an increase in salivary sodium after use of dentifrices containing either 5% or 0% CSPS, but no differences between them. Salivary phosphorous concentration decreased significantly with all treatments 2-5 min after use. There were no significant between-treatment differences in intra-oral pH. Products were generally well tolerated. This study establishes that it is possible to measure changes in salivary ionic composition derived through oral retention of CSPS, delivered via a dentifrice.
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Prospective and Randomized Evaluation of ChronOS and Bio-Oss in Human Maxillary Sinuses: Histomorphometric and Immunohistochemical Assignment for Runx 2, Vascular Endothelial Growth Factor, and Osteocalcin.
Bonardi, JP, Pereira, RDS, Boos Lima, FBDJ, Faverani, LP, Griza, GL, Okamoto, R, Hochuli-Vieira, E
Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons. 2018;(2):325-335
Abstract
PURPOSE The aim of this study was to compare ChronOS (β-tricalcium phosphate), Bio-Oss, and their addition to an autogenous bone graft in a 1:1 ratio in human maxillary sinus bone augmentation. MATERIALS AND METHODS Thirty maxillary sinuses were divided in 5 groups: group 1 included 6 maxillary sinuses grafted with autogenous bone graft alone; group 2 included 6 maxillary sinuses grafted with ChronOS; group 3 included 6 maxillary sinuses grafted with ChronOS and autogenous bone graft in a 1:1 ratio; group 4 included 6 maxillary sinuses grafted with Bio-Oss; and group 5 included 6 maxillary sinuses grafted with Bio-Oss and autogenous bone graft in a 1:1 ratio. The number of samples for each group was determined by the statistical power test. RESULTS The median areas of new bone formation in groups 1, 2, 3, 4, and 5 were 121,917.0, 83,787.0, 99,295.0, 65,717.0, and 56,230.0 μm2, respectively. Statistically significant differences were found between groups 3 and 5, groups 1 and 4, and groups 1 and 5 (P < .05). The median areas of remaining biomaterial were 2,900.5, 5,291.0, 2,662.0, 56,258.5, and 64,753.5 μm2 in groups 1, 2, 3, 4 and 5, respectively. Statistically significant differences occurred between groups 1 and 5, groups 3 and 5, and groups 2 and 5 (P < .05). Areas of connective tissue were 67,829.0 ± 22,984.6 μm2 in group 1, 97,445.9 ± 18,983.3 μm2 in group 2, 88,256.0 ± 21,820.5 μm2 in group 3, 65,501.8 ± 6,297.6 in group 4, and 70,203.2 ± 13,421.3 μm2 in group 5. CONCLUSIONS ChronOS combined with autogenous bone graft presented a behavior similar to that of autogenous bone graft alone. However, the groups treated with Bio-Oss showed immuno-labeling results indicating maturation of grafted bone.
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The Effect of Increasing Dialysate Magnesium on Serum Calcification Propensity in Subjects with End Stage Kidney Disease: A Randomized, Controlled Clinical Trial.
Bressendorff, I, Hansen, D, Schou, M, Pasch, A, Brandi, L
Clinical journal of the American Society of Nephrology : CJASN. 2018;(9):1373-1380
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Abstract
BACKGROUND AND OBJECTIVES Serum calcification propensity is a novel functional test that quantifies the functionality of the humeral system of calcification control. Serum calcification propensity is measured by T50, the time taken to convert from primary to secondary calciprotein particle in the serum. Lower T50 represents higher calcification propensity and is associated with higher risk of cardiovascular events and death in patients with ESKD. Increasing magnesium in serum increases T50, but so far, no clinical trials have investigated whether increasing serum magnesium increases serum calcification propensity in subjects with ESKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We conducted a single-center, randomized, double-blinded, parallel group, controlled clinical trial, in which we examined the effect of increasing dialysate magnesium from 1.0 to 2.0 mEq/L for 28 days compared with maintaining dialysate magnesium at 1.0 mEq/L on T50 in subjects undergoing hemodialysis for ESKD. The primary end point was the value of T50 at the end of the intervention. RESULTS Fifty-nine subjects were enrolled in the trial, and of these, 57 completed the intervention and were analyzed for the primary outcome. In the standard dialysate magnesium group, T50 was 233±81 minutes (mean±SD) at baseline (mean of days -7 and 0) and 229±93 minutes at follow-up (mean of days 21 and 28), whereas in the high dialysate magnesium group, T50 was 247±69 minutes at baseline and 302±66 minutes at follow-up. The difference in T50 between the two groups at follow-up (primary analysis) was 73 minutes (between-group difference; 95% confidence interval, 30 to 116; P<0.001), and the between-group difference in serum magnesium was 0.88 mg/dl (95% confidence interval, 0.66 to 1.10; P=0.001). CONCLUSIONS Increasing dialysate magnesium increases T50 and hence, decreases calcification propensity in subjects undergoing maintenance hemodialysis. PODCAST This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2018_08_21_CJASNPodcast_18_9_B.mp3.
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A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders.
Coughlan, M, Davies, M, Mostert, AK, Nanda, D, Willems, PC, Rosenberg, G, Ferch, R
Spine. 2018;(15):E860-E868
Abstract
STUDY DESIGN A prospective, Phase IV, multicenter, randomized study. OBJECTIVE The aim of this study was to compare vertebral fusion success rates following posterolateral fusion [(PLF)/posterolateral intertransverse fusion (PITF)] surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) and PLF with internal fixation over one or two levels using silicated calcium phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in patients with a degenerative disorder of the lumbar spine. SUMMARY OF BACKGROUND DATA Few controlled trials have evaluated the bone graft materials available to surgeons treating patients with spinal disorders, including degenerative disc disease, spondylolisthesis, and disc herniation. METHODS Following randomization, the surgical procedure consisting of PLIF and PLF with internal fixation over one or two levels was performed using SiCaP or BMP-2. No other osteoconductive/osteoinductive graft materials were permitted. Spinal fusion was assessed radiographically at ≤24 months. Clinical outcomes (pain on visual analog scale, Oswestry Disability Index, SF-36) and adverse events (AEs) were monitored. RESULTS One hundred three patients were enrolled. At 12 months, fusion was achieved in 25 of 35 (71.4%) of the SiCaP and 20 of 27 (74.1%) of the BMP-2 group, respectively (P = 1.000). At 24 months, the fusion rate was 78.6% and 84.8% for SiCaP and BMP-2, respectively (P = 0.5613). Clinical outcomes improved similarly in both groups over time. AEs were consistent with this surgical population. CONCLUSION SiCaP was safe and well tolerated in patients with degenerative spinal disorders requiring PLF and provided fusion rates similar to BMP-2. LEVEL OF EVIDENCE 2.