Le Grazie di Ancona, Italy
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Farahmand P.,University of Cologne | Marin F.,Lilly Research Center | Hawkins F.,Hospital 12 Of Octubre | Moricke R.,Institute For Praventive Medizin And Klinische Forschung | And 17 more authors.
Osteoporosis International | Year: 2013

Changes of the bone formation marker PINP correlated positively with improvements in vertebral strength in men with glucocorticoid-induced osteoporosis (GIO) who received 18-month treatment with teriparatide, but not with risedronate. These results support the use of PINP as a surrogate marker of bone strength in GIO patients treated with teriparatide. Introduction: To investigate the correlations between biochemical markers of bone turnover and vertebral strength estimated by finite element analysis (FEA) in men with GIO. Methods: A total of 92 men with GIO were included in an 18-month, randomized, open-label trial of teriparatide (20 μg/day, n = 45) and risedronate (35 mg/week, n = 47). High-resolution quantitative computed tomography images of the 12th thoracic vertebra obtained at baseline, 6 and 18 months were converted into digital nonlinear FE models and subjected to anterior bending, axial compression and torsion. Stiffness and strength were computed for each model and loading mode. Serum biochemical markers of bone formation (amino-terminal- propeptide of type I collagen [PINP]) and bone resorption (type I collagen cross-linked C-telopeptide degradation fragments [CTx]) were measured at baseline, 3 months, 6 months and 18 months. A mixed-model of repeated measures analysed changes from baseline and between-group differences. Spearman correlations assessed the relationship between changes from baseline of bone markers with FEA variables. Results: PINP and CTx levels increased in the teriparatide group and decreased in the risedronate group. FEA-derived parameters increased in both groups, but were significantly higher at 18 months in the teriparatide group. Significant positive correlations were found between changes from baseline of PINP at 3, 6 and 18 months with changes in FE strength in the teriparatide-treated group, but not in the risedronate group. Conclusions: Positive correlations between changes in a biochemical marker of bone formation and improvement of biomechanical properties support the use of PINP as a surrogate marker of bone strength in teriparatide-treated GIO patients. © 2013 The Author(s).


Saia F.,University of Bologna | Komukai K.,Interventional Cardiology Unit | Capodanno D.,University of Catania | Sirbu V.,Interventional Cardiology Unit | And 12 more authors.
JACC: Cardiovascular Imaging | Year: 2015

Objectives The aim of this study was to evaluate the pathophysiological features and response to primary percutaneous coronary intervention (PCI) of nonruptured/eroded plaque versus ruptured plaque as a cause of ST-segment elevation myocardial infarction (STEMI). Background Autopsy series identified nonruptured/eroded plaque and ruptured plaque as the principal pathological substrates underlying coronary thrombosis in STEMI. The real incidence of different plaque morphologies, associated biological factors, superimposed thrombus, and their interaction with primary PCI remain largely unknown. Methods In a prospective study, 140 patients with STEMI underwent optical coherence tomography of the infarct-related artery (IRA) before PCI, after everolimus-eluting stent implantation and at 9-month follow-up. Histopathology and immunohistochemistry of thrombus aspirates and serum biomarkers were assessed at baseline. Results Culprit plaque morphology was adjudicated in 97 patients: 32 plaques (33.0%) with an intact fibrous cap (IFC), 63 (64.9%) plaques with a ruptured fibrous cap (RFC), and 2 (2.1%) spontaneous dissections. Patients with an IFC and RFC had similar clinical characteristics, and serum inflammatory and platelets biomarkers. An IFC presented more frequently with a patent IRA (56.2% vs. 34.9%; p = 0.047), and had fewer lipid areas (lipid-rich areas: 75.0% vs. 100.0%; p < 0.001) and less residual thrombus before stenting (white thrombus: 0.41 mm3 vs. 1.52 mm3; p = 0.001; red thrombus: 0 mm3 vs. 0.29 mm3; p = 0.001) with a lower peak of creatine kinase-myocardial band (66.6 IU/l vs. 149.8 IU/l; p = 0.025). At the 9-month optical coherence tomography, IFC and RFC had similar high rates of stent strut coverage (92.5% vs. 91.2%; p = 0.15) and similar percentage of volume obstruction (12.6% vs. 10.2%; p = 0.27). No significant differences in clinical outcomes were observed up to 2 years. Conclusions In the present study, an IFC was observed at the culprit lesion site of one-third of STEMIs. IFC, compared with RFC, was associated with higher rates of patent IRA at first angiography, fewer lipid areas, and residual endoluminal thrombus. However, no difference in vascular response to everolimus-eluting stent was observed. (Optical Coherence Tomography Assessment of Gender Diversity in Primary Angioplasty [OCTAVIA]; NCT01377207) © 2015 American College of Cardiology Foundation.


PubMed | CV Path Institute, University of Padua, University of Bologna, Interventional Cardiology Unit and 6 more.
Type: Clinical Trial | Journal: JACC. Cardiovascular imaging | Year: 2015

The aim of this study was to evaluate the pathophysiological features and response to primary percutaneous coronary intervention (PCI) of nonruptured/eroded plaque versus ruptured plaque as a cause of ST-segment elevation myocardial infarction (STEMI).Autopsy series identified nonruptured/eroded plaque and ruptured plaque as the principal pathological substrates underlying coronary thrombosis in STEMI. The real incidence of different plaque morphologies, associated biological factors, superimposed thrombus, and their interaction with primary PCI remain largely unknown.In a prospective study, 140 patients with STEMI underwent optical coherence tomography of the infarct-related artery (IRA) before PCI, after everolimus-eluting stent implantation and at 9-month follow-up. Histopathology and immunohistochemistry of thrombus aspirates and serum biomarkers were assessed at baseline.Culprit plaque morphology was adjudicated in 97 patients: 32 plaques (33.0%) with an intact fibrous cap (IFC), 63 (64.9%) plaques with a ruptured fibrous cap (RFC), and 2 (2.1%) spontaneous dissections. Patients with an IFC and RFC had similar clinical characteristics, and serum inflammatory and platelets biomarkers. An IFC presented more frequently with a patent IRA (56.2% vs. 34.9%; p= 0.047), and had fewer lipid areas (lipid-rich areas: 75.0% vs. 100.0%; p< 0.001) and less residual thrombus before stenting (white thrombus: 0.41 mm(3) vs. 1.52 mm(3); p= 0.001; redthrombus: 0 mm(3) vs. 0.29 mm(3); p= 0.001) with a lower peak of creatine kinase-myocardial band (66.6 IU/l vs. 149.8IU/l; p= 0.025). At the 9-month optical coherence tomography, IFC and RFC had similar high rates of stent strutcoverage (92.5% vs. 91.2%; p= 0.15) and similar percentage of volume obstruction (12.6% vs. 10.2%; p= 0.27). Nosignificant differences in clinical outcomes were observed up to 2 years.In the present study, an IFC was observed at the culprit lesion site of one-third of STEMIs. IFC, compared with RFC, was associated with higher rates of patent IRA at first angiography, fewer lipid areas, and residual endoluminal thrombus. However, no difference in vascular response to everolimus-eluting stent was observed. (OpticalCoherence Tomography Assessment of Gender Diversity in Primary Angioplasty [OCTAVIA]; NCT01377207).


Gluer C.-C.,Universitatsklinikum Schleswig Holstein | Marin F.,Lilly Research Center | Ringe J.D.,Klinikum Leverkusen | Hawkins F.,Hospital 12 Of Octubre | And 17 more authors.
Journal of Bone and Mineral Research | Year: 2013

Data on treatment of glucocorticoid-induced osteoporosis (GIO) in men are scarce. We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations. Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months. Primary objective was to compare lumbar spine (L1-L3) BMD measured by quantitative computed tomography (QCT). Secondary outcomes included BMD and microstructure measured by high-resolution QCT (HRQCT) at the 12th thoracic vertebra, biomechanical effects for axial compression, anterior bending, and axial torsion evaluated by finite element (FE) analysis from HRQCT data, aBMD by dual X-ray absorptiometry, biochemical markers, and safety. Computed tomography scans were performed at 0, 6, and 18 months. A mixed model repeated measures analysis was performed to compare changes from baseline between groups. Mean age was 56.3 years. Median GC dose and duration were 8.8 mg/d and 6.4 years, respectively; 39.1% of subjects had a prevalent fracture, and 32.6% received prior bisphosphonate treatment. At 18 months, trabecular BMD had significantly increased for both treatments, with significantly greater increases with teriparatide (16.3% versus 3.8%; p = 0.004). HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure. Vertebral strength increases at 18 months were significant in both groups (teriparatide: 26.0% to 34.0%; risedronate: 4.2% to 6.7%), with significantly higher increases in the teriparatide group for all loading modes (0.005 < p < 0.015). Adverse events were similar between groups. None of the patients on teriparatide but five (10.6%) on risedronate developed new clinical fractures (p = 0.056). In conclusion, in this 18-month trial in men with GIO, teriparatide showed larger improvements in spinal BMD, microstructure, and FE-derived strength than risedronate. Copyright © 2013 American Society for Bone and Mineral Research.


Ozen S.,Hacettepe University | Pistorio A.,IRCCS G Gaslini | Iusan S.M.,IRCCS G Gaslini | Bakkaloglu A.,Hacettepe University | And 36 more authors.
Annals of the Rheumatic Diseases | Year: 2010

Objectives: To validate the previously proposed classification criteria for Henoch-Schönlein purpura (HSP), childhood polyarteritis nodosa (c-PAN), c-Wegener granulomatosis (c-WG) and c-Takayasu arteritis (c-TA). Methods: Step 1: retrospective/prospective webdata collection for children with HSP, c-PAN, c-WG and c-TA with age at diagnosis ≤18 years. Step 2: blinded classification by consensus panel of a representative sample of 280 cases. Step 3: statistical (sensitivity, specificity, area under the curve and κ-agreement) and nominal group technique consensus evaluations. Results: 827 patients with HSP, 150 with c-PAN, 60 with c-WG, 87 with c-TA and 52 with c-other were compared with each other. A patient was classified as HSP in the presence of purpura or petechiae (mandatory) with lower limb predominance plus one of four criteria: (1) abdominal pain; (2) histopathology (IgA); (3) arthritis or arthralgia; (4) renal involvement. Classification of c-PAN required a systemic inflammatory disease with evidence of necrotising vasculitis OR angiographic abnormalities of medium-/small-sized arteries (mandatory criterion) plus one of five criteria: (1) skin involvement; (2) myalgia/muscle tenderness; (3) hypertension; (4) peripheral neuropathy; (5) renal involvement. Classification of c-WG required three of six criteria: (1) histopathological evidence of granulomatous inflammation; (2) upper airway involvement; (3) laryngo-tracheo-bronchial involvement; (4) pulmonary involvement (x-ray/CT); (5) antineutrophilic cytoplasmic antibody positivity; (6) renal involvement. Classification of c-TA required typical angiographic abnormalities of the aorta or its main branches and pulmonary arteries (mandatory criterion) plus one of five criteria: (1) pulse deficit or claudication; (2) blood pressure discrepancy in any limb; (3) bruits; (4) hypertension; (5) elevated acute phase reactant. Conclusion: European League Against Rheumatism/Paediatric Rheumatology International Trials Organisation/Paediatric Rheumatology European Society propose validated classification criteria for HSP, c-PAN, c-WG and c-TA with high sensitivity/specificity.


Addimanda O.,Rizzoli Orthopaedic Institute | Mancarella L.,Rizzoli Orthopaedic Institute | Dolzani P.,Rizzoli Orthopaedic Institute | Punzi L.,University of Padua | And 3 more authors.
Arthritis Care and Research | Year: 2012

Objective. To characterize the clinical and radiographic joint phenotype in erosive hand osteoarthritis (EHOA) and non-EHOA. Methods. A total of 446 patients with HOA (233 with EHOA and 213 with non-EHOA) were evaluated. Demographic (sex and age at disease onset), clinical (body mass index and distribution of nodes), and radiographic features (Kellgren/Lawrence and Kallman's scores obtained from radiographs of both hands) from all patients were recorded. Results. Patients with EHOA had a significantly earlier disease onset. Clinical and radiographic distribution of structural damage in the distal interphalangeal (DIP), proximal interphalangeal (PIP), and first carpometacarpal joints was similar in EHOA and non-EHOA. EHOA patients showed higher percentages of nodes and more severe radiographic scores; the more severe radiographic score of joints with nodes was due to both osteophytes and joint space narrowing (JSN). A direct correlation between osteophytes and JSN scores was observed. Central erosions (CE) were more prevalent in the DIP joints than in the PIP joints. Gull-wing pattern of CE was prevalent in the DIP joints, whereas saw-tooth pattern was prevalent in the PIP joints. Marginal erosions (ME) were present in 100% of EHOA patients and in 80% of non-EHOA patients. An ordinal correlation between the presence of ME and osteophyte score was found. Conclusion. We found quantitative, but not topographic, differences in structural damage between EHOA and non-EHOA. Heberden's nodes, severe radiologic scores, and CE were concentrated in the second, third, and fifth DIP joints of both hands. ME were also present in the majority of non-EHOA patients. © 2012, American College of Rheumatology.

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