PubMed Journals Articles About "Clinical Trial Of Teriparatide In Japan" RSS

10:05 EST 13th November 2019 | BioPortfolio

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Showing "Clinical Trial Teriparatide Japan" PubMed Articles 1–25 of 33,000+

Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial.

Procollagen type I N-terminal propeptide (P1NP), a bone formation marker, reportedly predicts bone mineral density (BMD) response to teriparatide treatment in treatment-naive patients with osteoporosis. Results from a randomized, phase 3, open-label, active-controlled trial- STRUCTURE-showed that in patients previously treated with bisphosphonates, romosozumab led to gains in hip BMD, which were not observed with teriparatide. This post hoc analysis investigated the comparative utility of early changes in P...

Liver phantom design and dosimetric verification in participating institutions for a proton beam therapy in patients with resectable hepatocellular carcinoma: Japan Clinical Oncology Group trial (JCOG1315C).

In Japan, the first domestic clinical trial of proton beam therapy for the liver was initiated as the Japan Clinical Oncology Group trial (JCOG1315C: Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma). Purposes of this study were to develop a new dosimetric verification system and to carry out a credentialing for the JCOG1315C clinical trial.

Comparison of Teriparatide and Denosumab in Patients Switching from Long-Term Bisphosphonate Use.

Teriparatide and denosumab are effective treatments for osteoporosis and typically reserved as second-line options after patients have used bisphosphonates. However, limited head-to-head comparative effectiveness data exist between teriparatide and denosumab.

Clinical effectiveness of denosumab, raloxifene, romosozumab, and teriparatide for the prevention of osteoporotic fragility fractures: A systematic review and network meta-analysis.

To determine the clinical effectiveness of denosumab (DEN), raloxifene (RLX), romosozumab (ROMO) and teriparatide (TPTD), within their licensed (or anticipated licensed) indications, for the treatment of osteoporosis.

Standard vs Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial.

In the absence of an intervening antiresorptive agent, cyclic administration of teriparatide does not increase BMD more than standard daily therapy. Since denosumab is a potent antiresorptive agent with a rapid off-effect, we hypothesized that it might be the optimal agent to help maximize bone gains with cyclic teriparatide. In this 3 year protocol, 70 postmenopausal women with osteoporosis were randomized to: 18 months teriparatide followed by 18 months denosumab (Standard) or 3 separate 12 month cycles o...

Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow.

In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.

Artificial Intelligence for Clinical Trial Design.

Clinical trials consume the latter half of the 10 to 15 year, 1.5-2.0 billion USD, development cycle for bringing a single new drug to market. Hence, a failed trial sinks not only the investment into the trial itself but also the preclinical development costs, rendering the loss per failed clinical trial at 800 million to 1.4 billion USD. Suboptimal patient cohort selection and recruiting techniques, paired with the inability to monitor patients effectively during trials, are two of the main causes for high...

Successful treatment of pathologic femoral shaft fracture associated with large arteriovenous malformations using a 3-dimensional external fixator and teriparatide: a case report.

Arteriovenous malformations (AVMs) are rare congenital vascular lesions associated with early quiescence, late expansion, and, ultimately, infiltration and destruction of local soft tissue and bone. The extremities are a common location. Incidence of bony involvement by AVM has been reported as high as 31%. However, there are few reports on management of pathologic fracture associated with AVM. Teriparatide is a recombinant parathyroid hormone (PTH) analogue consisting of the 1-34 fragment of PTH. Recently,...

Assessment of Consistency Between Peer-Reviewed Publications and Clinical Trial Registries.

Clinical trial registries are intended to increase clinical research transparency by nonselectively identifying and documenting clinical trial designs and outcomes. Inconsistencies in reported data undermine the utility of such registries and have previously been noted in general medical literature.

OCTANE: Oncology Clinical Trial Annotation Engine.

Many targeted therapies are currently available only via clinical trials. Therefore, routine precision oncology using biomarker-based assignment to drug depends on matching patients to clinical trials. A comprehensive and up-to-date trial database is necessary for optimal patient-trial matching.

A nationwide survey of fetal myelomeningocele in Japan: Backgrounds for fetal surgery.

Fetal surgery for myelomeningocele (MMC) has yet not been performed in Japan, and the clinical backgrounds of fetal MMC in Japan remain poorly described. We examined the prenatal characteristics and perinatal outcomes of fetal MMC to prepare for the introduction of fetal surgery.

Teriparatide improves alveolar bone modelling after tooth extraction in orchiectomized rats.

The aim of this study was to evaluate bone metabolism in the alveolar repair process in orchiectomized male rats treated with teriparatide.

Changing clinical and molecular characteristics of hepatitis E virus infection in Mie Prefecture, Japan: disappearance of indigenous subtype 3e strains.

To evaluate the clinical and molecular characteristics of hepatitis E virus (HEV) infection in Mie Prefecture, Japan, from 2004 through 2018.

Evaluation of Pharmaceutical Company Payments and Conflict of Interest Disclosures Among Oncology Clinical Practice Guideline Authors in Japan.

Clinical practice guidelines (CPGs) are important in advancing the quality of medical care. Financial relationships between physicians and pharmaceutical companies may influence clinical practice. In accordance with the Japan Pharmaceutical Manufacturers Association guidelines for transparency, pharmaceutical company payments to physicians have been disclosed since 2013. The distribution of pharmaceutical company payments among CPG authors in Japan has not been studied.

A pragmatic, adaptive clinical trial design for a rare disease: The FOcal Cerebral Arteriopathy Steroid (FOCAS) trial.

Pediatric stroke investigators identified as their top research priority a clinical trial of corticosteroids for focal cerebral arteriopathy (FCA). However, FCA is both rare and an acute condition making it infeasible to enroll the large sample sizes needed for standard, confirmatory clinical trials. We present a pragmatic approach to clinical trial design that may inform the approach to other rare disorders.

Letter to the Editor: "Comparison of teriparatide and denosumab in patients switching from long-term bisphosphonate use".

The long-term outcomes of pediatric-onset primary sclerosing cholangitis: a single center experience in Japan.

Primary sclerosing cholangitis (PSC) is very rare in Japan. Although a large-scale cohort study of 781 pediatric-onset PSC patients in Europe and North America demonstrated that the 5-year survival with native liver was 88%, the long-term outcomes of pediatric-onset PSC in Japan are unknown. Here we evaluated the clinical outcomes of pediatric-onset PSC in Japan.

Predominance of methicillin-resistant Staphylococcus aureus SCCmec type II-CC5 and SCCmec type IV-CC1/CC8 among companion animal clinical isolates in Japan; findings from phylogenetic comparison with human clinical isolates.

To characterize genotypic profiles of MRSA clinical isolates from companion animals to investigate their association with those from human in Japan.

Emulating a Novel Clinical Trial Using Existing Observational Data: Predicting Results of the PreVent Study.

"Target trial emulation" has been proposed as an observational method to answer comparative effectiveness questions, but it has rarely been attempted concurrently with a randomized clinical trial (RCT).

Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product.

In January 2017, the European Commission approved Terrosa (company code RGB-10) as one of the first biosimilar medicinal products of teriparatide for the same indications as for the reference medicinal product Forsteo (Lilly France S.A.S.), which has been on the market in the European Union since 2003. The active pharmaceutical ingredient of the reference medicinal product is the biologically active 1-34 fragment of the endogenous human parathyroid hormone [PTH(1-34)]. It is one of the three bone anabolic a...

Applying Data Warehousing to a Phase III Clinical Trial From the Fondazione Italiana Linfomi Ensures Superior Data Quality and Improved Assessment of Clinical Outcomes.

Data collection in clinical trials is becoming complex, with a huge number of variables that need to be recorded, verified, and analyzed to effectively measure clinical outcomes. In this study, we used data warehouse (DW) concepts to achieve this goal. A DW was developed to accommodate data from a large clinical trial, including all the characteristics collected. We present the results related to baseline variables with the following objectives: developing a data quality (DQ) control strategy and improving ...

Phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil versus definitive chemoradiotherapy for locally advanced unresectable squamous-cell carcinoma of the thoracic esophagus (JCOG1510: TRIANgLE).

A randomized phase III trial commenced in Japan in February 2018. Definitive chemoradiotherapy (CRT) with cisplatin plus 5-fluorouracil is the current standard treatment for locally advanced unresectable esophageal carcinoma. The purpose of this study is to confirm the superiority of induction chemotherapy with docetaxel plus cisplatin and 5-fluorouracil (DCF) followed by conversion surgery or definitive CRT over definitive CRT alone for overall survival (OS) in patients with locally advanced unresectable s...

Clinical Practice Guidelines for Hepatocellular Carcinoma: The Japan Society of Hepatology 2017 (4th JSH-HCC Guidelines) a 2019 update.

The 4th version of Clinical Practice Guidelines for Hepatocellular Carcinoma was revised by the Japan Society of Hepatology, according to the methodology of evidence-based medicine and partly to the Grading of Recommendations Assessment, Development and Evaluation system, which was published in October 2017 in Japanese. New or revised recommendations were described, herein, with a special reference to the surveillance, diagnostic and treatment algorithms.

Immediate vs. Delayed Loading of Mandibular Implant-Retained Overdentures: A 60-month Follow-up of a Randomized Clinical Trial.

The purpose of this observational, post-trial follow up study, was to evaluate 60-month outcomes of a randomized controlled clinical trial, that compared immediate and delayed loaded two unsplinted implants, supporting a Locator retained mandibular overdenture.

Randomized Prospective Clinical Trial of Class II Restorations Using Low-shrinkage Flowable Resin Composite.

The aim of this prospective, randomized, split-mouth clinical trial was to evaluate postoperative sensitivity, clinical performance, and interproximal contacts after using different restorative systems.

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