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David L Kendler, Fernando Marin, Cristiano A F Zerbini, Luis A Russo, Susan L Greenspan, Vit Zikan, Alicia Bagur, Jorge Malouf-Sierra, Péter Lakatos, Astrid Fahrleitner-Pammer, Eric Lespessailles, Salvatore Minisola, Jean Jacques Body, Piet Geusens, Rüdiger Möricke, Pedro López-Romero
BACKGROUND: No clinical trials have compared osteoporosis drugs with incident fractures as the primary outcome. We compared the anti-fracture efficacy of teriparatide with risedronate in patients with severe osteoporosis. METHODS: In this double-blind, double-dummy trial, we enrolled post-menopausal women with at least two moderate or one severe vertebral fracture and a bone mineral density T score of less than or equal to -1·50. Participants were randomly assigned to receive 20 μg of teriparatide once daily plus oral weekly placebo or 35 mg of oral risedronate once weekly plus daily injections of placebo for 24 months...
November 9, 2017: Lancet
Ernesto Canalis
Skeletal anabolic agents enhance bone formation, which is determined by the number and function of osteoblasts. Signals that influence the differentiation and function of cells of the osteoblast lineage play a role in the mechanism of action of anabolic agents in the skeleton. Wnts induce the differentiation of mesenchymal stem cells toward osteoblasts, and insulin-like growth factor I (IGF-I) enhances the function of mature osteoblasts. The activity of Wnt and IGF-I is controlled by proteins that bind to the growth factor or to its receptors...
November 7, 2017: European Journal of Endocrinology
S L Greenspan, K Vujevich, C Britton, A Herradura, G Gruen, I Tarkin, P Siska, B Hamlin, S Perera
The Fracture Improvement with Teriparatide (Fix-IT) study randomized 13 women with an atypical femur fracture to immediate vs delayed teriparatide therapy; all were followed for 12 months. Results suggested a trend for superior healing and lesser bone mineral density declines in the immediate vs delayed group with no differences in adverse events. PURPOSE: Little clinical data are available on the use of teriparatide for the treatment of bisphosphonate-associated atypical femur fractures (AFF)...
October 30, 2017: Osteoporosis International
Allison Keshishian, Natalie Boytsov, Russel Burge, Kelly Krohn, Louise Lombard, Xiang Zhang, Lin Xie, Onur Baser
BACKGROUND: In the United States, osteoporosis affects approximately 10 million people, of whom 80% are women, and it contributes a significant clinical burden to the community. Poor adherence to osteoporosis medications adds to the overall burden of illness. OBJECTIVE: To examine the association of osteoporosis medication adherence and the risk of a subsequent fracture among Medicare-enrolled women with a previous fragility fracture. METHODS: This study was a retrospective observational analysis of U...
November 2017: Journal of Managed Care & Specialty Pharmacy
Toshinobu Omiya, Jun Hirose, Tomoka Hasegawa, Norio Amizuka, Yasunori Omata, Naohiro Izawa, Hisataka Yasuda, Yuho Kadono, Morio Matsumoto, Masaya Nakamura, Takeshi Miyamoto, Sakae Tanaka
We examined the effect of teriparatide, and switching from teriparatide to anti-RANKL (receptor activator of nuclear factor κB ligand) monoclonal antibody, in ovariectomized mice. Twelve-week-old female C57BL/6 mice were ovariectomized or sham operated. Four weeks after surgery, ovariectomized mice were subjected to one of the following four treatments: phosphate-buffered saline (PBS) for 8weeks; teriparatide for 4weeks followed by PBS for 4weeks (PTH4W group); teriparatide for 8weeks (PTH8W group); or teriparatide for 4weeks followed by anti-RANKL antibody (single subcutaneous injection of 5mg/kg) (SWITCH group)...
November 2, 2017: Bone
Rena J Eudy-Byrne, William Gillespie, Matthew M Riggs, Marc R Gastonguay
A hazard model of fracture was developed using individual patient data (IPD) from the NHANES (2005-2008) database and summary-level data from an aggregate dataset (AD). The AD was built by performing a comprehensive and systematic literature search of clinical studies published from 1995 to 2015, recording fracture rate and bone mineral density (BMD) for both treatment and placebo arms. The search resulted in a metadata set comprised of 21 studies investigating the effects of various bisphosphonates, teriparatide, denosumab, and raloxifene in 65,254 patients over a cumulative 56...
October 28, 2017: Journal of Pharmacokinetics and Pharmacodynamics
Natalie Diepenhorst, Patricia Rueda, Anna E Cook, Philippe Pastoureau, Massimo Sabatini, Christopher J Langmead
Osteoporosis is a progressive bone disorder characterised by imbalance between bone building (anabolism) and resorption (catabolism). Most therapeutics target inhibition of osteoclast-mediated bone resorption, but more recent attention in early drug discovery has focussed on anabolic targets in osteoblasts or their precursors. Two marketed agents that display anabolic properties, strontium ranelate and teriparatide, mediate their actions via the G protein-coupled calcium-sensing and parathyroid hormone-1 receptors, respectively...
October 25, 2017: Pharmacology & Therapeutics
Chunyan Lu, Yun Chen, Bin Zhang, Yu Chen, Fan Bai, Decai Chen
Teriparatide is the first anabolic agent for osteoporosis, and this analysis aimed to understand responses to teriparatide in Chinese patients with established osteoporosis in subgroups. In this Phase III study of teriparatide in China, 362 patients were randomized at a 2:1 ratio to receive subcutaneous teriparatide (20 μg/day) or intranasal salmon calcitonin (200 IU/day) for 24 weeks. Teriparatide treatment produced a significantly greater increase in lumbar spine bone-mineral density (LS-BMD) in postmenopausal women than calcitonin at the 24-week end point...
2017: Clinical Interventions in Aging
Jean-Yves Reginster, Nasser Mohammad Al Daghri, Olivier Bruyere
The recently published Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) assessed the efficacy and safety of abaloparatide (80 µg daily subcutaneous) (ABL) vs placebo during 18 months, in postmenopausal osteoporosis. Teriparatide (20 µg daily subcutaneous) (TPD) was used as an open label active comparator. The results of the study suggest that ABL increases bone mineral density more than TPD and reduces major osteoporotic fractures to a greater extent than TPD with a more rapid onset of action...
November 14, 2017: Expert Opinion on Pharmacotherapy
Lindsey Nicol, Ying Wang, Rosamund Smith, John Sloan, Sandesh C S Nagamani, Jay Shapiro, Brendan Lee, Eric Orwoll
Sclerostin (SOST), a glycoprotein primarily derived from osteocytes, is an important regulator of bone remodeling. Osteogenesis imperfecta ([1]) is a heritable disorder of bone characterized by low bone mass, bone fragility, recurrent fractures, and bone deformities. Altered SOST-mediated signaling may have a role in pathogenesis of type I collagen-related OI; however this has not been evaluated in humans. We measured serum SOST levels in adults with OI who were enrolled in a randomized, placebo-controlled clinical trial that evaluated the effects of osteoanabolic therapy with teriparatide...
October 17, 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
David W Dempster, Hua Zhou, Robert R Recker, Jacques P Brown, Christopher P Recknor, E Michael Lewiecki, Paul D Miller, Sudhaker D Rao, David L Kendler, Robert Lindsay, John H Krege, Jahangir Alam, Kathleen A Taylor, Thomas E Melby, Valerie A Ruff
There has been renewed interest of late in the role of modeling-based formation (MBF) during osteoporosis therapy. Here we describe early effects of an established anabolic (teriparatide) versus antiresorptive (denosumab) agent on remodeling-based formation (RBF), MBF, and overflow MBF (oMBF) in human transiliac bone biopsies. Postmenopausal women with osteoporosis received subcutaneous teriparatide (n = 33, 20 μg/d) or denosumab (n = 36, 60 mg once/6 months), open-label for 6 months at 7 US and Canadian sites...
October 12, 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
Kohei Nishitani, Zachary Mietus, Christopher A Beck, Hiromu Ito, Shuichi Matsuda, Hani A Awad, Nicole Ehrhart, Edward M Schwarz
Small animal studies have demonstrated significant high-dose recombinant parathyroid hormone1-34 (rPTH1-34) effects on intercalary allograft healing. Towards a human adjuvant therapy to decrease non-unions, we evaluated rPTH1-34 safety and efficacy in a clinically relevant canine femoral allograft model. Adult female mongrel hounds (n = 20) received a 5cm mid-diaphyseal osteotomy reconstructed with a plated allograft, and were randomized to: 1) Placebo (n = 5; daily saline), 2) Continuous rPTH1-34 (n = 7; 5 μg/kg/day s...
2017: PloS One
Takayuki Dohke, Kousuke Iba, Megumi Hanaka, Kumiko Kanaya, Shunichiro Okazaki, Toshihiko Yamashita
Recent studies have indicated that teriparatide, an anti-osteoporosis agent, significantly improves back pain regardless of the presence of vertebral fracture in osteoporosis patients. The aims of this study were to examine whether teriparatide improves pain-like behavior in an ovariectomized (OVX) mouse model, and to evaluate changes in osteoclast marker levels and inflammatory cytokine expression levels induced by teriparatide treatment in bone tissue in association with improvements in pain-like behavior...
October 5, 2017: Journal of Bone and Mineral Metabolism
Kazuma Kitaguchi, Masafumi Kashii, Kosuke Ebina, Takashi Kaito, Rintaro Okada, Takahiro Makino, Takaaki Noguchi, Takuya Ishimoto, Takayoshi Nakano, Hideki Yoshikawa
OBJECTIVE: The purpose of this study is to investigate the effects of a single or combination therapy of teriparatide (TPTD) and anti-RANKL Ab (anti-murine receptor activator of nuclear factor κB ligand monoclonal antibody) on the regeneration of both cancellous and cortical bone. METHODS: Nine-week-old mice underwent bone defect surgery on the left femoral metaphysis (cancellous-bone healing model) and right femoral mid-diaphysis (cortical-bone healing model)...
October 1, 2017: Bone
Wen Zhang, Junxiong Zhu, Teng Ma, Can Liu, Bao Hai, Guohong Du, Hong Wang, Nan Li, Huijie Leng, Yingsheng Xu, Chunli Song
To compare the efficacy of once-weekly and once-daily subcutaneous injections of teriparatide (recombinant human parathyroid hormone 1-34) on fracture healing, 50 adult male Sprague-Dawley rats were subjected to a unilateral tibia fracture and received internal fixation with a Kirschner needle. Based on the injection dose and frequency, the rats were randomly divided into five groups (n = 10 each): subcutaneous injections of saline or 10 µg/kg/w, 20 µg/kg/w, 10 µg/kg/d and 20 µg/kg/d teriparatide...
September 28, 2017: Journal of Orthopaedic Research: Official Publication of the Orthopaedic Research Society
G Hohenberger, A Schwarz, E Hartwig, B Bücking
No abstract text is available yet for this article.
November 2017: Der Unfallchirurg
T Shimizu, T Tanaka, T Kobayashi, I Kudo, M Nakatsugawa, A Takakura, R Takao-Kawabata, T Ishizuya
Bisphosphonates (BPs) and teriparatide (TPTD) are both effective treatments for osteoporosis, but BP treatment prior to daily TPTD treatment has been shown to impair the effect of TPTD in some clinical studies. In contrast, the loss of bone mineral density (BMD) that occurs after withdrawal of TPTD can be prevented by BP treatment. Although various studies have investigated the combination and/or sequential use of BP and TPTD, there have been no clinical studies investigating sequential treatment with zoledronic acid (ZOL) and TPTD (or vice versa)...
December 2017: Bone Reports
Lenore Buckley, Gordon Guyatt, Howard Fink, Timothy McAlindon
The Voting Panel recommended oral bisphosphonates as a first choice and parenteral bisphosphonates as a second choice after comparing data about absolute fracture reduction, harms (toxicity and inconvenience of daily injections), and costs. Drs. Maricic, Deal, Dore, and Laster cite the randomized trial of alendronate versus teriparatide in glucocorticoid-treated patients that reported incident fractures as a secondary outcome. This trial found a lower risk of clinical vertebral fractures in the teriparatide compared to alendronate treated patients (0% vs...
September 21, 2017: Arthritis Care & Research
Michael Maricic, Chad Deal, Robin Dore, Andrew Laster
We have read the recently published 2017 American College of Rheumatology Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis (1), and applaud the committee's efforts, but have a number of areas of disagreement. Our main concern is that in adults at high risk for fracture, oral and then parenteral bisphosphonates are recommended over teriparatide in selecting drug therapy. This represents a departure from the 2010 ACR GIO Guidelines (2) which avoided rating bisphosphonates (either oral or parenteral) preferentially over teriparatide...
September 21, 2017: Arthritis Care & Research
Jeffrey R Vieregg, Steven J Martin, Adam P Breeland, Christopher M Weikart, Matthew V Tirrell
For many years, glass has been the default material for parenteral packaging, but the development of advanced plastics such as cyclic olefin polymers (COP) and the rapidly increasing importance of biologic drugs have provided new choices, as well as more stringent performance requirements. In particular, many biologics must be stored at non-neutral pH, where glass is susceptible to hydrolysis, metal extraction, and delamination. Plastic containers are not susceptible to these problems, but suffer from higher gas permeability and a propensity for sterilization-induced radical generation, heightening the risk of oxidative damage to sensitive drugs...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
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