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Annette Bennedsgaard Jespersen, Andreas Duch Kiilerich Andresen, Michael Kjær Jacobsen, Mikkel Ø Andersen, Leah Y Carreon
STUDY DESIGN: Prospective, randomized double-blinded placebo-controlled clinical trial. OBJECTIVE: To evaluate if 90-day subcutaneous injections with 20 μg teriparatide increases the volume and quality of the fusion mass compared to placebo based on 12 month postop fine cut CT-scans. The secondary objective is to evaluate if PTH increases fusion rates compared to placebo. SUMMARY OF BACKGROUND DATA: Few studies have investigated the effects of PTH on fusion in patients undergoing spinal arthrodesis...
July 12, 2018: Spine
Pilar Z Murphy, Maryam Iranikhah, Crystal M Deas, Maisha K Freeman
OBJECTIVE: To review and summarize studies on the changes in bone mineral density (BMD) and fracture risk following discontinuation of teriparatide therapy. DATA SOURCES: A search of PubMed (1966-May 2016) and International Pharmaceutical Abstracts (1970-May 2016) was conducted using the Medical Subject Headings terms teriparatide, osteoporosis, and withholding treatment. Free text searches included drug holiday, discontinuation, and drug discontinuation. STUDY SELECTION AND DATA EXTRACTION: These searches yielded 79 articles...
July 1, 2018: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
Lia Mara Montagner Rossi, Rafaela Martinez Copes, Leo Canterle Dal Osto, Clovis Flores, Fábio Vasconcellos Comim, Melissa Orlandin Premaor
Although fractures had high mortality and morbidity, many studies proved that fracture risk might be decreased by pharmacological therapy, although a low treatment adherence rate is observed. The aim of this study was to identify factors associated with osteoporosis treatment in postmenopausal women.A cross-sectional study was carried out from March to August 2013 at the primary care setting. Postmenopausal women were recruited. A standardized questionnaire was applied. Women who were using at least one of the following drugs at the moment of the survey were considered as current treatment: bisphosphonates, raloxifene, estrogen, calcitonin, teriparatide, or strontium ranelate...
July 2018: Medicine (Baltimore)
Masayo Sato, Mika Tsujimoto, Kenta Kajimoto, Hideyuki Uetake, Hiroo Shimoda, Saeko Fujiwara
Japanese patients with osteoporosis prescribed once-daily teriparatide for 24 months could enroll in a patient-support program designed to aid adherence and persistence. Patients enrolled in the program had higher adherence and persistence rates than those who did not enroll, highlighting the value of patient-support programs for improving adherence and persistence. OBJECTIVE: To assess the effect of a patient-support program on once-daily teriparatide adherence and persistence of patients who did and did not enroll...
July 5, 2018: Archives of Osteoporosis
A Gilsenan, A Harding, N Kellier-Steele, D Harris, K Midkiff, E Andrews
The Forteo Patient Registry (FPR) aims to estimate the incidence of osteosarcoma in US patients treated with teriparatide. Enrollment began in 2009 and will continue through 2019, with linkage planned through 2024. To date, no incident cases of osteosarcoma have been identified among patients registered in the FPR. INTRODUCTION: The Forteo Patient Registry (FPR) was established in 2009 to estimate the incidence of osteosarcoma in US patients treated with teriparatide. The objective of this paper is to describe study methods, challenges encountered, and progress to date...
July 5, 2018: Osteoporosis International
R Winzenrieth, L Humbert, S Di Gregorio, E Bonel, M García, L Del Rio
Effects of osteoporosis drugs on proximal femur cortical and trabecular bone were studied using dual-energy x-ray absorptiometry (DXA)-based 3D modeling method. Changes observed in this head-to-head study were consistent with those obtained using computed tomography in the literature. INTRODUCTION: The aim of the present study was to assess the effects of osteoporosis drugs on cortical and trabecular bone at the proximal femur using DXA-based 3D modeling. METHODS: We retrospectively analyzed 155 patients stratified by treatments: naive of treatment (NAIVE), alendronate (AL), denosumab (DMAB), and teriparatide (TPTD)...
July 4, 2018: Osteoporosis International
Atsushi Watanabe, Kazuyuki Tsurui, Shigeki Yoneyama, Hijiri Iwata, Takayuki Anzai, Christopher Jerome, Dai Nakae
Teriparatide, a drug used in the treatment of osteoporosis, was administered to rats subcutaneously for the duration of 3 months, at a frequency of either once weekly or once daily to demonstrate the varying levels of anabolic action the drug can have on bone depending on the dosing frequency. The levels of biomarkers in the blood were compared and found to vary in osteocalcin (OC), a biomarker of bone formation, and cross-linked N-telopeptide of type 1 collagen (NTx), a biomarker of bone resorption, according to the dosing frequency...
2018: Journal of Toxicological Sciences
Shangzhi Gao, Maolin He
No abstract text is available yet for this article.
June 26, 2018: Spine
Jessica Starr, Yu Kwang Donovan Tay, Elizabeth Shane
PURPOSE OF REVIEW: To summarize reports published since the 2013 American Society of Bone and Mineral Research Task Force Report on atypical femoral fractures (AFF). RECENT FINDINGS: The absolute incidence of AFFs remains low. AFFs are primarily associated with prolonged bisphosphonate (BP) exposure, but have also been reported in unexposed patients and those receiving denosumab for osteoporosis and metastatic bone disease. Asians may be more susceptible to AFFs...
June 27, 2018: Current Osteoporosis Reports
Jean-Yves Reginster, Gary Hattersley, Gregory C Williams, Ming-Yi Hu, Lorraine A Fitzpatrick, E Michael Lewiecki
Abaloparatide (ABL) is a 34-amino acid peptide designed to be a selective activator of the parathyroid hormone receptor type 1 signaling pathway. In the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), subcutaneous ABL reduced the risk of new vertebral, nonvertebral, clinical, and major osteoporotic fracture compared with placebo and of major osteoporotic fracture compared with teriparatide. To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data...
June 27, 2018: Calcified Tissue International
Atsushi Iwai, Fumihiko Kajii, Hidenori Tanaka, Kazuo Sasaki, Keiko Matsui, Tadashi Kawai, Shinji Kamakura
OBJECTIVE: Octacalcium phosphate (OCP) and collagen (col) composite (OCPcol) demonstrated superior bone regeneration properties, and its commercialization appears to be forthcoming. As a practical medical material for new combination products, we developed a freeze-dried composite with OCPcol and teriparatide (TPTD) (OCPcolTPTDf), and investigated its bone regenerative properties. MATERIALS AND METHODS: A disk of OCPcol was made by mixing OCP granules and atelocollagen for medical use...
June 26, 2018: Oral Diseases
I Kastirr, M Reichardt, R Andresen, S Radmer, G Schröder, T Westphal, T Mittlmeier, H C Schober
The absence of osseous consolidation of a fracture for 9 or more months with no potential to heal is defined as nonunion. Both for the patient and from a socioeconomic point of view, nonunions represent a major problem. Hypertrophic, vital nonunions are distinguished from atrophic avital ones. Risk factors for a delayed fracture healing are insufficient immobilisation, poor adaptation of the fracture surfaces or residual instability, interposition of soft tissue within the fracture gap, as well as circulation disturbances and infections...
June 21, 2018: European Journal of Orthopaedic Surgery & Traumatology: Orthopédie Traumatologie
Kouichi Yamamoto, Yukihiro Isogai, Takayuki Ishida, Keisuke Hagihara
Teriparatide is clinically used for the treatment of osteoporosis; however, nausea is often observed in patients. Its insufficient control affects the ability to continue teriparatide therapy. Rikkunshi-To (RKT), a traditional Japanese herbal medicine, improves the gastrointestinal function via activation of the ghrelin-signaling system. We investigated the therapeutic effects of RKT on teriparatide-induced nausea in rats and the involvement of ghrelin in these effects. We previously reported that ovariectomized rats showed pica (kaolin ingestion), a behavior that can be used to assess nausea in rats, after the subcutaneous administration of teriparatide; thus, the behavior was used as an index of nausea...
May 17, 2018: Journal of Pharmacological Sciences
Nicola Napoli, Bente L Langdahl, Östen Ljunggren, Eric Lespessailles, George Kapetanos, Tomaz Kocjan, Tatjana Nikolic, Pia Eiken, Helmut Petto, Thomas Moll, Erik Lindh, Fernando Marin
This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide...
June 16, 2018: Calcified Tissue International
W Brent Edwards, Narina Simonian, Ifaz T Haider, Alan S Anschel, David Chen, Keith E Gordon, Elaine K Gregory, Ki H Kim, Ramadevi Parachuri, Karen L Troy, Thomas J Schnitzer
Spinal cord injury (SCI) is associated with marked bone loss and an increased risk of fracture. We randomized 61 individuals with chronic SCI and low bone mass to receive either: teriparatide 20 µg/day plus sham vibration 10 min/day (n = 20), placebo plus vibration 10 min/day (n = 20), or teriparatide 20 µg/day plus vibration 10 min/day (n = 21). Patients were evaluated for 12 months; those who completed were given the opportunity to participate in an open-label extension where all participants (n = 25) received teriparatide 20 µg/day for an additional 12 months and had the optional use of vibration (10 min/day)...
June 15, 2018: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
Takayuki Hamano
Despite the advent of cinacalcet and noncalcium-containing phosphate binders, controlling the progression of vascular calcification (VC) is still challenging. Recent reports demonstrate that carbamylation driven by high urea concentration aggravates VC, suggesting the importance of adequate dialysis in retarding its progression. Theoretically, other promising measures include the use of iron-based phosphate binders, vitamin K, and magnesium supplements, which should be investigated in future randomized controlled trials (RCTs), ideally with hard outcomes...
June 13, 2018: Seminars in Dialysis
Elisa Martín-Merino, Amaia Calderón-Larrañaga, Samuel Hawley, Beatriz Poblador-Plou, Ana Llorente-García, Irene Petersen, Daniel Prieto-Alhambra
Background: Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. Aim: To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). Methods: New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998-2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR...
2018: Clinical Epidemiology
Daniel Wolverton, David P Elliott
OBJECTIVE: To review clinical trial data supporting the use of drugs to treat osteoporosis in the oldest adults, 74 years of age and older. DATA SOURCES: The PubMed database (September 1969-June 2017) was searched utilizing the following Medical Subject Headings terms: osteoporosis, postmenopausal, aged, 80 and over, and fractures, bone, in combination with diphosphonates, denosumab, parathyroid hormone, raloxifene, and calcitonin. STUDY SELECTION/DATA EXTRACTION: An initial search revealed 119 results, of which 18 clinical trials were included...
June 1, 2018: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
Norimitsu Wakao, Mikinobu Takeuchi, Daniel K Riew, Atsuhiko Hirasawa, Shiro Imagama, Katsuhisa Kawanami, Toshihiro Matsuo, Kenta Murotani, Masataka Deie
Although patients with osteoporotic delayed vertebral collapse (ODVC) have frequently been treated surgically, the efficacy and limitation of conservative treatment for it have not yet been reported. The purpose of this study was to investigate the effectiveness and limitation of further intensive conservative treatment for patients with ODVC.Patients treated for ODVC from 2011 to 2014 with a follow-up period of more than 1 year were eligible. The fundamental treatment strategy consisted of surgical treatment following intensive conservative treatment with daily teriparatide and rehabilitation for 3 months...
June 2018: Medicine (Baltimore)
Tommaso Porcelli, Francesca Sessa, Angela Caputo, Christian Catalini, Domenico Salvatore
Thyroid cancer metastasizes in 4% of cases. Approximately two-thirds of these patients are refractory to radioactive iodine-131 (RAI) therapy and have a poor 10-year survival prognosis. Treatment with tyrosine kinase inhibitors (TKIs) may be administered in selected RAI-refractory patients. However, these agents are often associated with adverse events, including vomiting. We report the case of a patient affected by RAI-refractory thyroid cancer with lung and intracranial metastases undergoing treatment with the antiangiogenic TKI lenvatinib, and with teriparatide replacement therapy for postsurgical hypoparathyroidism...
2018: Frontiers in Endocrinology
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