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Silvina R Mastaglia, Gabriel Aguilar, Beatriz Oliveri
Bisphosphonates (BPs) are the most widely used drugs to treat osteoporosis. However, recent reports associated to long-term BPs use with atypical low-impact fractures and prodromal pain. It is estimated that 26% of the cases of atypical fractures associated with the long-term use of BPs show delayed healing or nonunion. Teriparatide [PTH1-34] (TPTD) is an anabolic drug shown to be effective in stimulating bone formation. The aim was to describe the course of a right diaphyseal femoral fracture sustained by a patient on long-term BPs treatment...
June 2016: Eur J Rheumatol
Smita Jha, Timothy Bhattacharyya
UNLABELLED: There is a strong impetus to prevent and treat osteoporosis to prevent fractures. $990 million dollars was spent on anti-osteoporosis drugs in 2013. As we shift our focus on primary prevention of fractures, providers are encouraged to find the most cost-effective anti-osteoporosis therapy for patients. PURPOSE: Osteoporosis is a major global problem with osteoporotic fractures posing a potentially avoidable burden on healthcare resources. We studied the utilization and cost of anti-osteoporotic therapy using the 2013 Medicare Part D data...
December 2016: Archives of Osteoporosis
Ben Antebi, Longze Zhang, Dmitriy Sheyn, Gadi Pelled, Xinping Zhang, Zulma Gazit, Edward M Schwarz, Dan Gazit
Although most fractures heal, critical defects in bone fail due to aberrant differentiation of mesenchymal stem cells towards fibrosis rather than osteogenesis. While conventional bioengineering solutions to this problem have focused on enhancing angiogenesis, which is required for bone formation, recent studies have shown that fibrotic non-unions are associated with arteriogenesis in the center of the defect and accumulation of mast cells around large blood vessels. Recently, recombinant parathyroid hormone (rPTH; teriparatide; Forteo) therapy have shown to have anti-fibrotic effects on non-unions and critical bone defects due to inhibition of arteriogenesis and mast cell numbers within the healing bone...
March 2016: Bioengineering
Javier Farías, Guillermo A Keller, Mariana Papouchado, María C Villa Etchegoyen, Marcelo E Criscuolo, Roberto A Diez, Guillermo Di Girolamo
OBJECTIVE: To compare the pharmacokinetics, relative bioavailability (RB), immunogenicity, and safety after a single dose of test or reference formulation of teriparatide in healthy human volunteers in order to demonstrate whether both products are similar. RESEARCH DESIGN AND METHODS: We compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers...
August 2016: International Journal of Clinical Pharmacology and Therapeutics
Mohit Bhandari, Ling Jin, Kyoungah See, Russel Burge, Nigel Gilchrist, Richard Witvrouw, Kelly D Krohn, Margaret R Warner, Qasim I Ahmad, Bruce Mitlak
BACKGROUND: There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo(®)/ Forsteo(®), recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing. QUESTIONS/PURPOSES: We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety...
May 2016: Clinical Orthopaedics and related Research
Torsten Johansson
BACKGROUND AND PURPOSE: There is solid evidence from animal experiments that parathyroid hormone (PTH) improves fracture healing. So far, only 3 papers on PTH and fracture repair in humans have been published. They suggest that PTH may enhance fracture healing, but the results do not appear to justify specific clinical recommendations. This study was carried out to determine whether teriparatide enhances fracture healing of proximal humerus fractures. PATIENTS AND METHODS: 40 post-menopausal women with a proximal humerus fracture were randomized to either daily injections with 20 µg teriparatide (PTH 1-34 (Forteo)) for 4 weeks or control treatment...
February 2016: Acta Orthopaedica
Richard G Kay, Jonathan T Hands, Glen Hawthorne, Scott Constable, Martin Grosvenor, Johannah A Sharman
BACKGROUND: The bioanalysis of Teriparatide (PTH 1-34) is extremely challenging due to the low plasma concentrations present at a therapeutic level. An LC-MS/MS-based method was developed that detected PTH 1-34 at 15 pg/ml in porcine plasma, and was validated using the bioanalytical method validation guidelines. RESULTS: The analytical methodology demonstrated good linearity over a range of 15-1000 pg/ml, and demonstrated good precision and accuracy. The validated method was used to support a trial comparing a solid state dose to a solution-based injection (Forteo™)...
2015: Bioanalysis
Pouran Famili, Jennifer M Zavoral
The aim of this case-control study (n = 30) was to evaluate the effects of osteoporosis/osteopenia on the success of dental implants. Twenty healthy females ages 50-80 with confirmed osteoporosis or osteopenia, and 10 age- and gender-matched subjects with normal bone density (controls) received dental implants. Dual-energy X-ray absorptiometry (DXA) scans at 5 standard sites (total body, hip, spine [lateral and anterior-posterior] and radius) were measured at baseline and 24 months. Periapical and panoramic radiographs were taken at baseline before implant placement; 1 periapical radiograph was taken immediately after placement of the dental implant...
October 2015: Journal of Oral Implantology
Markus R John, Evita Harfst, Juergen Loeffler, Rossella Belleli, June Mason, Gerard J M Bruin, Klaus Seuwen, Lloyd B Klickstein, Linda Mindeholm, Leo Widler, Michaela Kneissel
Antagonism of the calcium-sensing receptor in the parathyroid gland leads to parathyroid hormone (PTH) release. Calcilytics are a new class of molecules designed to exploit this mechanism. In order to mimic the known bone-anabolic pharmacokinetic (PK) profile of s.c. administered PTH, such molecules must trigger sharp, transient and robust release of PTH. The results of two early clinical studies with the orally-active calcilytic AXT914, a quinazolin-2ne derivative are reported. These were GCP-compliant, single and multiple dose studies of PK/PD and tolerability in healthy volunteers and postmenopausal women...
July 2014: Bone
Katie M Cergol, Robert E Thompson, Lara R Malins, Peter Turner, Richard J Payne
An efficient methodology for ligation at glutamate (Glu) is described. A γ-thiol-Glu building block was accessed in only three steps from protected glutamic acid and could be incorporated at the N-terminus of peptides. The application of these peptides in one-pot ligation-desulfurization chemistry is demonstrated with a range of peptide thioesters, and the utility of this methodology is highlighted through the synthesis of the osteoporosis peptide drug teriparatide (Forteo).
January 3, 2014: Organic Letters
Haleh Hamedifar, Firoozeh Salamat, Mohammad Saffarion, Mohammad Ghiasi, Alireza Hosseini, Hadi Lahiji, Zomorrod Nouri, Hamed Arfae, Fereidoun Mahboudi
BACKGROUND: Parathyroid hormone (PTH) secreted by parathyroid glands regulates the metabolism of calcium and phosphorus in bone and kidney. Thereby, it can stimulate bone formation, and is a promising agent in the treatment of osteoporosis. Mature form of PTH consists of 84 amino acids; however, the first 34 residues of PTH cover the majority of hormonal action. METHODS: In this study, the fusion form of highly soluble rhPTH was expressed at high level in Escherichia coli (E...
July 2013: Avicenna Journal of Medical Biotechnology
X Wan, Y Zhao, R Burge, Y Jiang
UNLABELLED: This was the first study to apply principal component analysis method to bone histomorphometric parameters. The results corroborated teriparatide's distinct, yet different, mechanisms of action, which stimulate both bone formation and resorption. INTRODUCTION: This study consolidated bone histomorphometric parameters and compared the effects of two osteoporosis treatments on bone remodeling by using a principal component analysis (PCA). METHODS: Included in this analysis were postmenopausal women with osteoporosis who were treated with either teriparatide or alendronate and who completed transiliac bone biopsy at either 6 or 18 months in the randomized, double-blind Forteo Alendronate Comparator Trial...
December 2013: Osteoporosis International
Brittany N Bohinc, Diane Gesty-Palmer
Parathyroid hormone (PTH) is the principle regulator of calcium-phosphorus metabolism and bone turnover. Because of its central role in bone remodeling, recombinant human PTH (i.e., Forteo®; PTH(1-34)) has been developed for the treatment of osteoporosis. PTH(1-34) acts principally through the type I PTH/PTH-related peptide receptor (PTH1R), a classic seven transmembrane G protein-coupled receptor (GPCR). Intermittent treatment with PTH(1-34) promotes osteoblast and osteoclast recruitment through activation of PTH1R with resultant net bone gain...
2013: Progress in Molecular Biology and Translational Science
Stanley S Lefkowitz, Doris L Lefkowitz, Jeremy Kethley
BACKGROUND: Facioscapulohumeral muscular dystrophy (FSHD) is the 3(rd) most common form of muscular dystrophy. Effective treatments for any of the muscular dystrophies have yet to be realized. This report describes such a treatment. CASE REPORT: A 66 year old female was diagnosed with osteoporosis. She had been diagnosed with FSHD muscular dystrophy a number of years previously by both genetic and clinical studies. Following a 2 year course with Forteo for osteoporosis, she was given an injection of Denosumab (Prolia) to maintain her bone density...
2012: American Journal of Case Reports
Yinfeng Zhang, Ci Xu, Hiu Yung Lam, Chi Lung Lee, Xuechen Li
An efficient method has been developed for the salicylaldehyde ester-mediated ligation of unprotected peptides at serine (Ser) or threonine (Thr) residues. The utility of this peptide ligation approach has been demonstrated through the convergent syntheses of two therapeutic peptides--ovine-corticoliberin and Forteo--and the human erythrocyte acylphosphatase protein (∼11 kDa). The requisite peptide salicylaldehyde ester precursor is prepared in an epimerization-free manner via Fmoc-solid-phase peptide synthesis...
April 23, 2013: Proceedings of the National Academy of Sciences of the United States of America
Erik R Sampson, Matthew J Hilton, Ye Tian, Di Chen, Edward M Schwarz, Robert A Mooney, Susan V Bukata, Regis J O'Keefe, Hani Awad, J Edward Puzas, Randy N Rosier, Michael J Zuscik
There is no disease-modifying therapy for osteoarthritis, a degenerative joint disease that is projected to afflict more than 67 million individuals in the United States alone by 2030. Because disease pathogenesis is associated with inappropriate articular chondrocyte maturation resembling that seen during normal endochondral ossification, pathways that govern the maturation of articular chondrocytes are candidate therapeutic targets. It is well established that parathyroid hormone (PTH) acting via the type 1 PTH receptor induces matrix synthesis and suppresses maturation of chondrocytes...
September 21, 2011: Science Translational Medicine
P Aggarwal, A Zavras
In the current era, various pharmacological agents exist for osteoporosis management, and synthetic parathyroid hormone (PTH) (Teriparatide, Forteo) is one of the treatment options. Depending on the timing of administration, PTH has a unique ability to cause both bone apposition and bone resorption. This review focuses on the effects of PTH on the bone, specifically the jaw bones mandible and maxilla. The article briefly describes the fundamental mechanism of PTH action at the molecular level, as well as in experimental animals and in humans...
January 2012: Oral Diseases
Gayathri Subramanian, Harold V Cohen, Samuel Y P Quek
OBJECTIVE: The objective of this study was to present a comprehensive model for the pathogenesis of bisphosphonate-associated osteonecrosis of the jaw (BON). STUDY DESIGN: Review of PubMed literature relevant to BON, bisphosphonates (BPs), and bone remodeling. RESULTS: Six case reports of spontaneous resolution of BON lesions following administration of teriparatide (Forteo; Eli Lilly and Co., Indianapolis, IN) were identified. These reports suggest that osteoanabolic therapies may hold promise in BON management...
December 2011: Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics
Kelly R Ragucci, Sarah P Shrader
Osteoporosis is a disease that results in decreased bone mass and quality of bone, which may lead to fracture. Clinicians need to counsel individuals on appropriate intake of calcium and vitamin D, increasing weight-bearing exercise, limiting alcohol and caffeine, and avoiding smoking. A variety of nonhormonal pharmacological options are available for prevention and treatment of osteoporosis, including bisphosphonates, calcitonin (Miacalcin®), raloxifene (Evista®), teriparatide (Forteo®), and denosumab (Prolia®)...
July 2011: Journal of Gerontological Nursing
Leif Mosekilde, Ove Tørring, Lars Rejnmark
Anabolic treatment that remodels bone tissue and restores bone biomechanical competence is essential in the treatment of osteoporosis. In addition, long term antiresorptive therapy may have limitations because of the reduced renewal of bone tissue. The only pure anabolic drugs available at present are intact PTH (1-84) (Preotact®) and the truncated PTH (1-34) (Teriparatide, Forteo®) while strontium ranelate may possess antiresorptive as well as anabolic properties. The marketed antiresorptive and anabolic antiosteoporotic drugs have limitations in their use due to adverse effects or to the occurrence of rare but severe late complications...
April 2011: Current Drug Safety
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