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Expert Opinion on Investigational Drugs | 1998

Olpadronate: a new amino-bisphosphonate for the treatment of medical osteopathies.

Emilio J. A Roldán; Aníbal Pérez-Llore; José Luis Ferretti

Olpadronate is a nitrogenated bisphosphonate. Although it shares the therapeutic and pharmacological properties of pamidronate and alendronate, it has a greater dosage amplitude, more predictable effects and a greater digestive tolerability than other bisphosphates. Therefore, it may be more appropriate in the treatment of medical osteopathies, by both oral and parenteral routes of administration. According to various experimental and human models, the pharmacological potency of olpadronate is 5- to 10-times higher than that of pamidronate and close to that of alendronate. The two methyl groups bound to the nitrogen atom give the compound a high water solubility, which is about 8-times higher than that of the two other bisphosphonates. The lack of a terminal amino group in the side-chain of the molecule and the absence of crystallised forms of the compound in the digestive tract (due to its high water solubility) may avoid the potential for inducing oesophageal and gastrointestinal side-effects. These features may explain the high tolerability reported after the administration of doses of olpadronate (by the oral route) up to 5- to 10-times higher than the maximum tolerated dose of alendronate in Pagets bone disease and bone metastases, thus widening the possibilities for its clinical usage. In addition, initial pharmacokinetic studies suggest that olpadronates oral bioavailability would fit into a confidence range of 2-4%, which contrasts with the erratic absorption shown by other highly potent bisphosphonates. The clinical efficacy demonstrated in preliminary studies in Pagets bone disease (including ultra-short treatments), and also in single-dose iv. therapy of hypercalcaemia of malignancies, renders olpadronate among the most promising bisphosphonate compounds, with potential use in the treatment of a variety of bone-involving diseases, such as osteoporosis, malignancies and rheumatoid arthritis.


Revista de la Facultad de Odontología | 2017

1º Fórum Internacional De Osteología En Odontología

José Luis Ferretti; Emilio J. A Roldán; María Rosa Ulla; Miguel Mario Fonseca

The primless enamel by dentine features are described through transparency, incidence and polarization microscopy. The polatization microscopy, with an uniform and constant thickness, identifies an structural organization distinct in its crystals. Its behavior in the Enamel Caries is like a natural barrier, that offers resistance to the cariogenic desmineralitationIt was done a comparative work to precise the As Ga laser action during the TemporoMandibular Disorders treatment, using pain, noise and mobility to measure the evolution of a twenty pacients group treated with and without laserExitosamente se realizaron las Primera Jornadas Odontologicas de la Facultad de Odontologia de la Universidad Nacional de Cordoba, los dias 13, 14, 15 y 16 de agosto del corriente ano, en el Pabellon Amarillo del Complejo Feriar Cordoba, y auspiciada por el Gobierno de la Provincia de Cordoba.Sub-superficial cariogenic demineralization in cuspidic areas its influence on cavity preparation. The aim of the present work was to analyse ex situ teeth with AD occlusal caries and evaluate surgical treatraent and filling with amalgama to determine if the extension and preparation of the cavity includes in al! its peripheric angle the desmineralized arcas. Thirty human teeth (patient age range 13-25 years, third molars and first premolars) fixed in neutral forrnalina pour 48 hs. and histologyc technique. Cavity carving and filling with amalgama. The sample were sectioned (VL) with carborundum disk. Observed by microscopy lateral incidence. Results: Revelated sub-superficial decalcification PAS + , 40 to 80 micrometers undept and extension 200 to 400 micrometers was not included in cavity preparation, corroborated by MEBSe estudiaron 27 pacientes con sindrome de obstruccion respiratoria. Por medio de telerradiografias laterales se evaluaron dimensiones de nasofaringe midiendo sobre las mismas hipertrofia de cornetes y adenoides. Otros estudios fueron realizados sobre telerradiografias frontales y rinomanometrias. Se realizaron cefalomgramas Ricketts y McNamara. Se obtuvo como resultado que el area libre en respiradores bucales por hipertrofia de cornetes y adenoides disminuye significativamente dificultando el pasaje aereo normal y que el valor medio de H.C. es de 8,2 mm. En el estudio de estructuras profundas el plano palatino, el mandibular, profundidad facial y altura facial inferior fueron los mas significativamente alterados (AU)Se analizan las circunstancias y caracteristicas del terreno oseo en irnplantologia, para llegar a un diagnostico del momento en que se aplicaran los implantes. Segun este analisis se los clasifica en inmediatos y diferidos. Los inmediatos tienen ventajas al reducir el tiempo operatorio y conservacion del proceso alveolar. En esta forma de implantar se pueden emplear recursos complementarios: dilatacion alveolar, injertos oseos autologos recubiertos con periostio, materiales osteotroficos u oseinico mineral, que evita la lisis del coagulo y favorece la coagulacion sanguinea y materiales para reforzar o de refuerzo corno es laesponja de titanio. Los diferidos respecto a su instalacion, pueden tener interrogantes en su pronostico por la existencia de areas osteoliticas que comprometen la instalacion de los implantes. La biopsia del terreno y el efecto estimulante de la cicatrizacion del alveolo quirurgico, son criterios aplicables a este tiempo para la insercion de los implantesEl objetivo general del presente trabajo fue disenar y evaluar modelos graficos directed acyclic (DAG) con estructura de causa suficiente para valorar relaciones causales entre un conjunto de variables clinicas medica-odontologica, psicologicas, moleculo-celulares y los fenotipos multifactoriales de enfermedades complejas. Se evaluaron variables binarias que se incorporaron a un modelo DAG con estructura de causa suficiente para cada patologia.Se realizo el estudio citoquimico y ultraestructural de las glandulas linguales del embrion de pollo con el objeto de analizar el desarrollo morfogenetico y los glicoconjugados elaborados por las mismas para inferir sus posibles significancias histofisiologicas con referencia a las glandulas salivales de esta especie. Se emplearon lengua de embriones de pollo de 7 a 19 dias de incubacion las que se procesaron para su estudio ultraestructural y citoquimico (Rojo de Rutenio, PAS, Alcian blue, Azul de Toluidina). A los 11 dias aparecian esbozos y cordones celulares canalizados cuyas celulas se relacionaban mediante complejos de union. No se detecto reaccion positiva para mucinas. A partir de los 15 dias los acinos estaban bien diferenciados, con granulos secretorios PAS positivos, alcianofilicos y metacromaticos. Poseian organelas tipicas de la sintesis proteica y secrecion luminal Rojo de Rutenio positiva, alcianofilica, metacromatica y PAS positiva. A los 19 dias se detecto un marcado incremento de las mucinas. Estas observaciones demuestran que las glandulas linguales estan citoquimica y ultraestructuralmente diferenciadas desde los 15 dias del desarrollo y contribuiran por medio de los glicoconjugados como ya ha sido establecido a la lubricacion de los alimentos. Ademas podrian iniciar el proceso digestivo de los mismos y protegerian a la mucosa bucal, evitando su deshidratacion y la proliferacion de germenes patogenosEn las pasadas decadas se ha observado un interes creciente en el estudio de las predisposiciones geneticas a las enfermedades complejas, esto ha desembocado en una enorme cantidad de publicaciones epidemiologicas sobre asociaciones entre gen y enfermedad. Sin embargo, no siempre la magnitud de la asociacion entre la presencia de un determinado genotipo y la enfermedad esta determinada, por lo cual es necesario identificar las verdaderas asociaciones geneticas entre la presencia de una enfermedad compleja y los genotipos de las personas. Uno de los puntos en contra de estos estudios son los tamanos de muestra con los que se realizan los estudios y las variantes genotipicas que deben estudiarse por lo cual las revisiones sistematicas y meta-analisis resultan herramientas valiosas para establecer certeramente las asociaciones entre genes y enfermedades. G M T Detect language Afrikaans Albanian Amharic Arabic Armenian Azerbaijani Basque Belarusian Bengali Bosnian Bulgarian Catalan Cebuano Chichewa Chinese (Simplified) Chinese (Traditional) Corsican Croatian Czech Danish Dutch English Esperanto Estonian Filipino Finnish French Frisian Galician Georgian German Greek Gujarati Haitian Creole Hausa Hawaiian Hebrew Hindi Hmong Hungarian Icelandic Igbo Indonesian Irish Italian Japanese Javanese Kannada Kazakh Khmer Korean Kurdish Kyrgyz Lao Latin Latvian Lithuanian Luxembourgish Macedonian Malagasy Malay Malayalam Maltese Maori Marathi Mongolian Myanmar (Burmese) Nepali Norwegian Pashto Persian Polish Portuguese Punjabi Romanian Russian Samoan Scots Gaelic Serbian Sesotho Shona Sindhi Sinhala Slovak Slovenian Somali Spanish Sundanese Swahili Swedish Tajik Tamil Telugu Thai Turkish Ukrainian Urdu Uzbek Vietnamese Welsh Xhosa Yiddish Yoruba Zulu Afrikaans Albanian Amharic Arabic Armenian Azerbaijani Basque Belarusian Bengali Bosnian Bulgarian Catalan Cebuano Chichewa Chinese (Simplified) Chinese (Traditional) Corsican Croatian Czech Danish Dutch English Esperanto Estonian Filipino Finnish French Frisian Galician Georgian German Greek Gujarati Haitian Creole Hausa Hawaiian Hebrew Hindi Hmong Hungarian Icelandic Igbo Indonesian Irish Italian Japanese Javanese Kannada Kazakh Khmer Korean Kurdish Kyrgyz Lao Latin Latvian Lithuanian Luxembourgish Macedonian Malagasy Malay Malayalam Maltese Maori Marathi Mongolian Myanmar (Burmese) Nepali Norwegian Pashto Persian Polish Portuguese Punjabi Romanian Russian Samoan Scots Gaelic Serbian Sesotho Shona Sindhi Sinhala Slovak Slovenian Somali Spanish Sundanese Swahili Swedish Tajik Tamil Telugu Thai Turkish Ukrainian Urdu Uzbek Vietnamese Welsh Xhosa Yiddish Yoruba Zulu Text-to-speech function is limited to 200 characters Options : History : Feedback : Donate CloseA study of Cordobas children population was made to evaluate the percentage of malocclusions and the necessity for treatrnent. 990 children of both sexes, fron first to seventh grade were chosen randomly out of the 16.870 students registered in 1993. Town Hall schools. To gather the data the epidemiological card to register malocclusions of qualitative range was used, made by the University of Dentistry of Montevideo, Uruguay, and this enabled us to determine the morphofunctional characteristics that prevail in temporary, mixed and permanent dentition. The results indicate a prevalence of abnormal lip closure and the presence of habits. The cuantitative register in mixed and permanent dentition to determine the orthodontic abnormality and evaluate the necessitty and priority of treatrnent was used in Buenos Aires by Dr. Teneban, Goto and Morales and it showed an 82% malocclusions and the highest percentage of anomalies in these teeth corresponded to the minor onea. The low percentage ofmalocclusions found in temporary dentition (19, 42%) and its increasing tendency as it evolver into permanent dentition makes us think of the necessity of regular controls from an early age to prevent and intercept malocclusionsA comparative study is made between the canica! external-based parallelizable pillars, prefabricated angled pillars and filtered angled pillars, obtained from calcinable· material. The conical external-based parallelizable pi!Hm; feature a design obtained by the direct, direct-indirect or indirect method, thus obtaining a personal emergence and optimum angulation in the sector to be replaced, with precise indications for the lower-front sector. It achieves a perfect adaptation of two machined surfaces which are either facing each other or in contact, avoiding galvanized corrosion as well as similar effects in the soft tissues. Its construction and constitution in a single piece prevents problems of fatigue and imperfection of the metal due to filteringLa Escuela de Graduados de la Facultad de Odontologia tiene bajo su responsabilidad la Educacion del cuarto nivel. Su principal objetivo es profundizar y actualizar la formacion docente, cientifica y tecnologica, lo cual se logra mediante la reflexion critica, la investigacion y el intercambio sobre los avances en las diferentes especialidades.The effects of the Nd-YAG and C02 lasers on the oral mucosa though the treatment of pathological processes with surgical indication such as leukoplakias, atypicallichens, hemangiomas and cancer with a follow-up of up two years are analizad in this paper. An experimental work in which portions of human oral mucosa were irradiated to acquire experience in the surgical method and to observe histologically the laser effects on the tissues under survey was done previously. Though the treatment of these lesions, beneficia! effects of these lasers such as absence of hemorrhage in al! the treated cases, little pain and edema in the inmediate post-op, scarce recurrence and scarring in the distant controls were observedcastration and simultaneous application of DMBA. Wistar young males were used, in groups of five animales each. They were sacriiiced lZ, Z3 and Z8 days after the experlment was started. The glands werediss~cted and fixed in 10 % formol at Ph. 7 in arder to be . studiedmorphohistochemically and histometrically. The number of mast cells increased in the sublingual gland (SLG) at all the time perlods studied, outnumbering considerably the cell population in the sub maxillary gland (SMG) lZ days after the animals had been castrated. When comparing uncastrated · animals with castrated ones, it is noticed that the most importantdifierences in the mast cell population appear in the SLG. With application of DMBA and simultaneous castration, it is observed that the sublingual gland (which normally has very little receptivity to DMBA in un castrated animals) experiences an atypical tissue response accompanied by anincrease in its mast cell populationLa Revista de la Facultad de Odontologia de la Universidad Nacional de Cordoba nacio con el animo de constituir un espacio de referencia en la investigacion en el campo de la OdontologiaIi describes the child[s ortjopedic treatment that shows the Pierre Robins Sequence (formely called pi erre Robins Syndrome). The treatment starts from the first week of life. The orthopedic trearment is perfomed with an acrylic prothesis which in vestibular area adheres to the superior alveolar ridges, thus showing at a post daming leve! a posterior prolongation appendage as a that coincides with the fissured area. Thanks to it, the tongue finds. This allows the tongue to descend and advance progresively and partly sol ve the micrognatism and the glosoptosis that characterized this pathology, and allows the child to be fed by a nursing bottle. This therapeutic resource, plus the usage of nipples and anatomic pacifiers and an adecuate postura! treatment (supino - prono position), allow a right feeding and also improve breathing problems, that is a characteristic of these children. The orthopedic outlook is a preparation for a successful surgical closing of the cleft, This, together with the phonoauidological treatment and the psychological support allows these children s rehabilitation befo re school age through a multi and interdisciplinary work.The structural and histochemical patterns of the salivary mesenchyma were analysed in relation to the epithelium of the labial glands during the embryonic development to correlata the structural and histochemical characteristics in both tissues during the histogenesis. Samples of h~man fetal lips were analysed using H/E, PAS, Casen, Alcian blue, Tolui dine blue and Methenamine/silver, The process of glandular histogenesis begun between B te 10 weeks. The mesenchy~a surrounding the glandular buds had PAS positiva granulations which were also alcianophilic, met~chromatic and periodatoreactive. Periodatoreactive collagenous fibrillae, reticular cells and nervous fibers of considerable diameter were observad. Basement _membranas were PAS positiva, alcianophilic and di~continu.ous, At 12 weeks the mesenchyma differentiated as loase conne~tive tissue which produced a delicate periglandular capsule with fibra blast and collagenous fibrillae. Froin 20 to 2q weeks ·the ac1n1 wer-i;;structurally and histochemically differentiated as serous, mucous and mixed, It was postulated that the periglandular mesenchyma would play and important role in the morphogenetic process in relation to the hist~chemical identification of molecules which have a specific biological functions in the epithelium-mesenchyma interactions during organogene sisSe estudiaron 22 pacientes de 5 a 12 anos de edad. desde el punto de vista clinico y radiologico, donde existian antecedentes de perdida prematura de piezas temporarias por extt·acciones y/o acc1dentes (luxaciones). Clinicamente se encontro en 17 casos que, cuando la perdida ocurria en piazos mayores a 1os 20 meses de 1a normal erupcion, se detectaba falta de erupcion de los permanentes. Ei criterio Dara hacer e1 diagnostico de erupcion retardada, se hizo tornando en referencia la erupcion del diente homologo. Las radiografias P.Srapica1es, mostraban esta pieza~ dentarias realizando su,trabajo de erupcion en la etapa 1ntraosea, quedando en retencion subli! Ucosa. El estudio ...bistopato1o_gico del tejido blando~ obtenido de la liberacion quirurgica de estos elementos, demostro fibrosis con grados variables de hia1inizacion dei tejido conjuntivo. En 5 casos, con P-lazos inferiores (8 a 12 meses} de tiempo de perdida}, la erupcion fue normal o acelerada. Se concluye que la perdida prematura de dientes tempor?rios cuando acontece en plazos mayores a los 20 meses, determma un retardo de eru~cion. que en los casos seleccionados para este estudio. obedecia a un proceso de fibrosis e hia1inizacion del tejido conjuntivo submucoso y papilar con caracteristicas de brida cicatrizal, que interpretamos como responsable de la retencion submucosa en estos elementosObjetivo: Generar un dialogo de saberes entre docentes y profesionales de diferentes niveles educativos de la provincia de Cordoba para contribuir a la mejora de la ensenanza de las Ciencias Naturales en el nivel primario. Metodos: Se planifico y desarrollo una capacitacion semi-presencial titulada “Viaje al mundo microscopico: Aportes de la microscopia del siglo XXI”, en base a la demanda de los docentes de escuela primaria en relacion a la tematica de la microscopia. Se realizaron encuentros teorico-practicos con utilizacion de microscopios y aparatologia relacionada, complementados con actividades en un aula virtual disenada a tal fin en la plataforma Moodle, con tutorias docentes e interaccion en foros. Resultados: Esta intervencion extensionista, de caracter interdisciplinario e integrado, tuvo un impacto muy positivo en los actores involucrados -profesores primarios y secundarios, formadores de futuros docentes y docentes universitarios- enriqueciendo el conocimiento de problematicas educativas y estrategias para afrontarlas. Conclusiones: Se considera que los ninos seran los principales beneficiarios de esta intervencion extensionista, la cual ha contribuido a promover la equidad y la calidad educativa. Se destaca asimismo que a traves de esta experiencia se genero una valiosa capacidad instalada -sostenible a traves del tiempo- de recursos de estudio y actividades de aplicacion virtuales, que permiten aprovechar el potencial pedagogico de las TIC.Las ciencias de la salud son, por su propia naturaleza intrinseca, un quehacer moral. Todas sus actividades, ya sean la practica clinica, la investigacion, la aplicacion de innovaciones tecnologicas, etc., estan en ultima instancia dirigidas a los seres humanos y sus decisiones tienen la intencion de hacerles bien.The fluoride ability to react with the enamel surface hodroxiapatite, transforming it in a fluorhirdroxiapatite, more strong to the acid action, is in part, the cariopreventive mechanisme of this chemical elemenL This action could be beneficia! for the primary dentition if fluoride supplements are administrated duriog pregnacy with an appropite dosage, specially if the family caries story and the sorrounding conditions alen about potential reisk for the future babyIn the present study it was investigated the histophysiology of the lingual salivary glands in white egret. Glands were processed by conventional histology (hematoxilin-eosin and Masson trichromic) and histochemical techniques including PAS, PAS/neuraminidase, alcian blue, toluidine blue and PNA lectin. The obtained results ha ve indicated the presence of numerous glands located anteroposterior and lateral !O the lingual cartila~e. In the anterior region, gla73ndular lo bes showed tubular structures formed by basophilic cuboidal cells.- In the posterior region a scarce number of mucous adenomers and intraepithelial glands were found. The histochemical reactions indicated the presence of glycoconjugate compounds in the glandular secretion. These glycoconjugates had a high number of terminal sialic acid residues because it was observed a decrease in PAS and alcian blue reactions after neuraminidase digestion. In addition, the affinity by PNA lectin was increased with enzymatic digestion. lt was also detected a strong alician.;philic and metachromatic sulphated groups. These findings showed that the glandular lingual secretion in these bires, present the same types of glycoconjugates as !hose described in mammals. In conclusion, this secretion could play a main role in food lubrication and non-inmune responsesEl articulo contiene los siguientes resumenes: Calidad de hueso y fragilidad por Prof. Jose Luis Ferretti Determinaciones cuantitativas de calidad osea y tratamiento de los estados de fragilidad por Dr. Emilio J. A. Roldan Evaluacion Del Estado Metabolico Del Esqueleto por Dra. Maria Rosa Ulla La Importancia Del Diagnostico En Implanto Logia por Prof. Dr. Miguel Mario Fonseca


Journal of Frailty, Sarcopenia and Falls | 2016

A controlled trial comparing one-year biochemical bone metabolism outcome in postmenopausal frail osteopenic women under weekly alendronate treatment, with or without whole-body vibration intervention

Ricardo Capiglioni; Claudia Gómez Acotto; Alicia Marino; María Georgina Muntaabski; Víctor Montangero; Luciana D’Alessio; Emilio J. A Roldán

The positive influence of regular exercise on bone properties has been described in several clinical studies in young and old healthy people. However, it is not yet well defined which loading type, dose, and schedule of intervention shows a higher impact on the skeleton. Although some guidelines are available, there is no general agreement about regular exercise prescription to postmenopausal frail women with osteopenia or osteoporosis. Addition of exercise programs to long-term treatments of osteoporotic individuals with bone metabolism modulators Abstract Purpose: The influence of regular exercise on bone properties is not well defined. Frail subjects have limitations to perform exercise with skeletal impact. This study aims to analyze whole-bone vibration treatment (WBV) as an enhancer of bisphosphonate effects in postmenopausal frail women with osteopenia/osteoporosis. Methods: Fiftythree postmenopausal sedentary osteopenic women were treated during 12 months with a drinkable alendronate (ALN) formulation. By randomization, 21 of them underwent a WBV (15-min sessions, 3 days per week) as an additional treatment. The serum C-terminal telopeptide of type I collagen (CTx) and total alkaline phosphatase (TAP) were determined at 0, 6 and 12 months of ALN therapy. In subgroups of 19/13 women, peripheral quantitative computerized tomography (pQCT) was applied at the tibia mid shaft to determine the volumetric BMD of cortical bone (CtBMDv) and the polar strain-strength index (SSIp). Results: CTx levels fell significantly deeper in the WBV subgroup (-39.3% and -30.3%, respectively, p<0.01), suggesting that in these women WBV promotes a greater effect of ALN on bone resorption inhibition. Basal CtBMDv and SSIp values were similar in both groups and were weakly (negatively) associated with basal CTx values. After treatment, the correlation between CtBMDv or SSIp values with CTx values were also weak and negative in the Sedentary subgroup but become positive and closer in the WBV subgroup. Conclusions: Vibration treatment enhanced the ALN-induced inhibition of bone resorption and may affect positively bone properties. Protracted treatments should show whether this trend is maintained as to effectively reduce the incidence of falls and skeletal fractures in frail subjects.


Current Therapeutic Research-clinical and Experimental | 2007

Tolerability of Intravenous Pamidronate for the Treatment of Osteoporosis and Other Metabolic Osteopathies: A Retrospective Analysis

Marcelo Sarli; Rodolfo Spivacow; Viviana Pedroarias; Emilio J. A Roldán; Jose Zanchetta

BACKGROUND Intravenous disodium pamidronate has been described in the treatment of several osteopathies. Although tolerability has been found to be good in clinical trials, some mild to serious adverse events (AEs) have been reported. OBJECTIVES The aims of this study were to analyze the toelrability of IV pamidronate in patients being treated for osteoporosis and other metabolic osteopathies and to describe particular patients with relative contraindications, because such cases are not commonly seen in daily clinical practice. METHODS We performed a retrospective analysis of patients with different osteopathies who were administered IV infusions of pamidronate at doses ranging from 15 to 90 mg/infusion and 15 to 900 mg/year. The study was conducted in patients who had received treatment at the Institute of Metabolic Investigations, University of Salvador, Buenos Aires, Argentina, between January 1995 and December 2003. To rule out dose-related AEs, a comparison was made between patients who received fewer IV infusions and had cumulative doses of 120 to 180 mg/y (less frequent administration [LFA] group) and those patients who received regular infusions and had cumulative doses of >180 mg/year (frequent administration [FA] group). To confirm data obtained from medical records and to assess the occurrence of AEs, attempts were made to interview all patients by phone. The following information was verified for each patient included in the study: the reason for treatment, documented evidence of current diagnostic criteria, and whether the dose administered was adequate to treat the patients condition. RESULTS Six hundred eight patients (464 [76.3%]women, 144 [23.7%]men; mean [SD] age, 69 [10] years) with various osteopathies (osteoporosis, 367 [60.4%] of the patients; Pagets disease, 172 [28.3%]; Sudecks disease, 63 [10.4%]; multiple myeloma, 3 [0.5%]; and bone metastases, 3 [0.5%]) were administered a total of 2933 IV infusions of pamidronate during the study period. We were able to confirm the clinical records of 69.4% (422/608) of the patients by telephone survey; 29.9% (124/415) of those patients experienced extraskeletal AEs (most commonly fever and flu-like symptoms [eg, headache, malaise, fatigue, chills, and asthenia]). The percentage of patients reporting AEs was significantly higher for the LFA group than that of the FA group (91.2 vs 19.5; P < 0.001), although factors other than the frequency of treatment might have had a bearing on this finding. All AEs were mild and transient in both groups of patients, and there were no reports of jaw osteonecrosis in either group. It should be noted that although LFA patients received lower doses of pamidronate per infusion than the FA group, they had higher cumulative doses/year. Biochemical variables for the entire study population were compared with baseline measurements, and no significant changes in mean values were observed. Both serum calcium and 25-hydroxy vitamin D levels remained within normal ranges. On the other hand, there was a transient decrease in white blood cell count (WBCC) in 73 (12.0%) patients, and leukopenia was observed in 8 (1.3%) patients. However, 5 of the 6 patients who were leukopenic at the beginning of treatment had normal WBCCs during follow-up. Platelet count decreased significantly in 20 (3.3%) patients, and 5 (0.8%) patients developed thrombocytopenia. Serum creatinine (sCreat) levels increased significantly in 91 (15.0%) patients. This increase was transient and within normal limits (0.6-1.2 mg/dL) in 79 (86.8%) of those patients but persistent in the other 12 (13.2%), all of whom received higher doses of pamidronate or had other risk factors for renal failure such as advanced age, diabetes, multiple myeloma, or an obstructor disease. Baseline sCreat level for 7 of these 12 patients was >1.20 mg/dL. CONCLUSIONS Pamidronate administered IV was well tolerated when used for treating osteoporosis or other metabolic osteopathies in our study population. The clinical AEs observed with IV pamidronate administration were not serious and hematologic changes were mild, transient, and not associated with dose, time of treatment, or any particular underlying disease. An increase in sCreat level was the most frequent biochemical complication and was found in patients with additional risk factors for renal failure and particular diseases. Whether certain patients with risk factors for osteoporosis may require even fewer IV administrations of the drug is an issue that remains to be elucidated.


Archive | 1995

Bone mass anabolic composition comprising olpadronate

Socrates Papapoulos; Jose Luis Ferretti; Rafael Alberto Labriola; Nélida Mondelo; Emilio J. A Roldán


Archive | 2001

Composition comprising bisphosphonates for prevention and/or treatment of metabolic diseases of bones, process for preparing such composition and use thereof

Daniel Zanetti; Damian Cairatti; Enrique Piccinni; Emilio J. A Roldán; Socrates Papapoulos


Archive | 2000

Use of bisphosphonates for the treatment of osteogenesis imperfecta

Emilio J. A Roldán; Aníbal Pérez Lloret


Drug Research | 2011

In vitro and in vivo equivalence studies of alendronate monosodium tablets.

Emilio J. A Roldán; Oscar Quattrocchi; Daniel Zanetti; Enrique Piccinni; José Tessler; Liliana Edith Caballero; Aníbal Pérez Lloret


Medicina-buenos Aires | 1997

Estudios morfologicos de los cristales de hidroxiapatita tratatos con pamidronato disodico

Lidia E Hein; Reynaldo L Grassi; Emilio J. A Roldán; Daniel Gregori; Maria E Varela; Enrique Piccinni


Medicina-buenos Aires | 1997

Morphological studies of hydroxyapatite crystals exposed to disodium pamidronate

Hein Le; Grassi Rl; Emilio J. A Roldán; Gregori D; Varela Me; Enrique Piccinni

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Jose Zanchetta

Universidad del Salvador

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Ricardo Capiglioni

National University of Rosario

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Gustavo Cointry

National University of Rosario

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