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https://www.readbyqxmd.com/read/28680788/profile-of-abaloparatide-and-its-potential-in-the-treatment-of-postmenopausal-osteoporosis
#1
REVIEW
Sri Harsha Tella, Anuhya Kommalapati, Ricardo Correa
Abaloparatide (previously known as BA058) is a synthetic 34-amino acid peptide and novel selective activator of parathyroid hormone receptor 1 (PTHR1) currently under development as a new anabolic agent in the management of osteoporosis. This paper reviews the profile and potential of abaloparatide in the treatment of postmenopausal osteoporosis. This paper is based on clinical trials and a PubMed search. Search terms used were "abaloparatide", "BA058", and "PTHrP". This review outlines the effects of this anabolic PTHR1 activator, which increases bone mineral density in patients at high risk for osteoporosis...
May 31, 2017: Curēus
https://www.readbyqxmd.com/read/28629610/a-model-for-assessing-the-clinical-and-economic-benefits-of-bone-forming-agents-for-reducing-fractures-in-postmenopausal-women-at-high-near-term-risk-of-osteoporotic-fracture
#2
Claire E O'Hanlon, Anju Parthan, Morgan Kruse, Shannon Cartier, Bjorn Stollenwerk, Yawen Jiang, John P Caloyeras, Daria B Crittenden, Richard Barron
PURPOSE: The goal of this study was to assess and compare the potential clinical and economic value of emerging bone-forming agents using the only currently available agent, teriparatide, as a reference case in patients at high, near-term (imminent, 1- to 2-year) risk of osteoporotic fractures, extending to a lifetime horizon with sequenced antiresorptive agents for maintenance treatment. METHODS: Analyses were performed by using a Markov cohort model accounting for time-specific fracture protection effects of bone-forming agents followed by antiresorptive treatment with denosumab...
June 16, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28624872/abaloparatide-first-global-approval
#3
Matt Shirley
Abaloparatide (Tymlos™) is a synthetic peptide analogue of human parathyroid hormone-related protein that was developed by Radius Health as an osteoanabolic agent for the treatment of postmenopausal osteoporosis. Abaloparatide acts through selective activation of the parathyroid hormone type 1 receptor signalling pathway. In April 2017, subcutaneous abaloparatide received its first global approval, in the USA, for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy...
June 17, 2017: Drugs
https://www.readbyqxmd.com/read/28609423/abaloparatide-tymlos-for-postmenopausal-osteoporosis
#4
(no author information available yet)
No abstract text is available yet for this article.
June 19, 2017: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/28529724/recent-advances-in-the-management-of-osteoporosis
#5
REVIEW
Seiji Fukumoto, Toshio Matsumoto
There has been substantial progress in the management of patients with osteoporosis and the prevention of osteoporotic fractures. Currently available strong anti-resorptive agents are bisphosphonates and an anti-receptor activator of nuclear factor-kappa B ligand (RANKL) antibody, denosumab. Although bisphosphonates and denosumab both inhibit bone resorption and prevent vertebral and non-vertebral fractures, their mechanisms of action are different. Whereas bisphosphonates' effects on bone mineral density and fracture peak around 3 to 5 years and become plateaued, those of denosumab are maintained for up to 10 years...
2017: F1000Research
https://www.readbyqxmd.com/read/28474780/the-effect-of-abaloparatide-sc-on-fracture-risk-is-independent-of-baseline-frax-fracture-probability-a-post-hoc-analysis-of-the-active-study
#6
Eugene V McCloskey, Helena Johansson, Anders Oden, Nicholas C Harvey, Hai Jiang, Sara Modin, Lorraine Fitzpatrick, John A Kanis
Daily subcutaneous (SC) injections of the investigational drug abaloparatide-SC (80 mcg) for 18 months significantly decrease the risk of vertebral and nonvertebral fracture compared with placebo in postmenopausal women. We examined the efficacy of abaloparatide-SC as a function of baseline fracture risk, assessed using the FRAX tool. Baseline clinical risk factors (age, body mass index [BMI], prior fracture, glucocorticoid use, rheumatoid arthritis, and smoking) were entered into country-specific FRAX models to calculate the 10-year probability of major osteoporotic fractures, with or without femoral neck bone mineral density (BMD)...
May 5, 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/28389324/comparing-the-incidence-of-bone-tumors-in-rats-chronically-exposed%C3%A2-to-the-selective-pth-type-1-receptor-agonist-abaloparatide%C3%A2-or%C3%A2-pth-1-34
#7
Jacquelin Jolette, Bassem Attalla, Aurore Varela, Gerald G Long, Nacera Mellal, Sabile Trimm, Susan Y Smith, Michael S Ominsky, Gary Hattersley
Prolonged treatment with human parathyroid hormone (hPTH) in rats results in development of bone tumors, though this finding has not been supported by clinical experience. The PTH type 1 receptor agonist abaloparatide, selected for its bone anabolic activity, is under clinical development to treat postmenopausal women with osteoporosis. To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years...
April 4, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28303448/parathyroid-hormone-and-parathyroid-hormone-related-protein-analogs-in-osteoporosis-therapy
#8
REVIEW
Benjamin Z Leder
PURPOSE OF REVIEW: The purpose is to review the efficacy and optimal use of parathyroid hormone and parathyroid hormone-related protein analogs in osteoporosis treatment. RECENT FINDINGS: The parathyroid hormone analog teriparatide, a potent stimulator of bone remodeling, increases hip and spine bone mineral density and reduces the risk of vertebral and non-vertebral fractures in postmenopausal osteoporotic women. The parathyroid hormone-related protein analog, abaloparatide, also reduces fracture incidence but has pharmacological effects that differ from teriparatide, particularly in cortical bone...
April 2017: Current Osteoporosis Reports
https://www.readbyqxmd.com/read/28286990/the-quest-for-new-drugs-to-prevent-osteoporosis-related-fractures
#9
REVIEW
T J de Villiers
There is a need for the development of new drugs to prevent osteoporosis-related fractures. Fractures are projected to increase and the present drugs have modest efficacy, significant side-effects and poor compliance. To illustrate the difficulties in the development of new drugs, the author reviews the fate of several drugs that have failed to gain regulatory approval. These drugs include arzoxifene, lasofoxifene, MK-5442, roncalceret and odanacatib. Romosozumab and abaloparatide are the only new drugs presently in phase-3 development...
April 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28160873/eighteen-months-of-treatment-with-subcutaneous-abaloparatide-followed-by-6-months-of-treatment-with-alendronate-in-postmenopausal-women-with-osteoporosis-results-of-the-activextend-trial
#10
RANDOMIZED CONTROLLED TRIAL
Felicia Cosman, Paul D Miller, Gregory C Williams, Gary Hattersley, Ming-Yi Hu, Ivo Valter, Lorraine A Fitzpatrick, Bente Juel Riis, Claus Christiansen, John P Bilezikian, Dennis Black
OBJECTIVE: To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis). PATIENTS AND METHODS: ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients. RESULTS: Of 1243 eligible ACTIVE patients, 1139 (92%) were enrolled in ACTIVExtend beginning November 20, 2012...
February 2017: Mayo Clinic Proceedings
https://www.readbyqxmd.com/read/28159062/abaloparatide-recombinant-human-pthrp-1-34-anabolic-therapy-for-osteoporosis
#11
REVIEW
Chee Kian Chew, Bart L Clarke
The treatment of osteoporosis is generally either by inhibition of bone resorption with antiresorptive agents or by stimulation of bone formation with anabolic agents. Currently, teriparatide (recombinant human parathyroid hormone 1-34 [rhPTH (1-34)]) is the only available approved anabolic agent in the U.S. Other anabolic agents are under investigation however. Abaloparatide is recombinant human parathyroid hormone-related peptide 1-34. This agent is an anabolic agent that appears more potent than teriparatide, and it may have more rapid onset of fracture reduction than teriparatide...
March 2017: Maturitas
https://www.readbyqxmd.com/read/28057953/daclizumab
#12
Anne P Kim, Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers...
December 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/28017957/-development-of-osteoporosis-drugs-the-past-the-present-and-the-future
#13
Shinya Tanaka
From 1990s to 2000s, new drugs for osteoporosis have been developed, and the bone metabolism researches have livened up. In those days, many a people gathered to the meeting from many countries, and the each booth of pharmaceutics was proud of its preeminence. The dedications by the society and its members have had osteoporosis diagnostics developed, the anchor drugs become prevalent, and the number of fractures reduced. Although the brilliant effects of Romosozumab and Abaloparatide were presented in the meeting held this year, the members had to accept the convergence state of new drug developments...
2017: Clinical Calcium
https://www.readbyqxmd.com/read/27920805/abaloparatide
#14
REVIEW
Stefano Gonnelli, Carla Caffarelli
Abaloparatide is an investigational analog of human PTHrP (1-34) being developed for the treatment of osteoporosis. The amino-acid sequence of abaloparatide is identical to that of PTHrP in the first 20 amino-acids, while over half of the remaining amino-acids are different. Some studies in animals and in humans reported that abaloparatide presented a potent anabolic activity with reduced effects on bone resorption as compared to that observed with teriparatide. This may be due to a more transient signaling response of abaloparatide related to differing affinities of the two drugs to the specific conformations of the PTH1 receptor...
May 2016: Clinical Cases in Mineral and Bone Metabolism
https://www.readbyqxmd.com/read/27894941/one-year-of-abaloparatide-a-selective-peptide-activator-of-the-pth1-receptor-increased-bone-mass-and-strength-in-ovariectomized-rats
#15
Aurore Varela, Luc Chouinard, Elisabeth Lesage, Robert Guldberg, Susan Y Smith, Paul J Kostenuik, Gary Hattersley
Abaloparatide is a novel 34 amino acid peptide selected to be a potent and selective activator of the parathyroid hormone receptor 1 (PTHR1) signaling pathway. The effects of 12months of abaloparatide treatment on bone mass, bone strength and bone quality was assessed in osteopenic ovariectomized (OVX) rats. SD rats were subjected to OVX or sham surgery at 6months of age and left untreated for 3months to allow OVX-induced bone loss. Eighteen OVX rats were sacrificed after this bone depletion period, and the remaining OVX rats received daily s...
February 2017: Bone
https://www.readbyqxmd.com/read/27859635/abaloparatide-is-an-anabolic-but-does-it-spare-resorption
#16
T John Martin, Ego Seeman
No abstract text is available yet for this article.
January 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/27826127/effects-of-abaloparatide-sc-ba058-on-bone-histology-and-histomorphometry-the-active-phase-3-trial
#17
Carolina A Moreira, Lorraine A Fitzpatrick, Yamei Wang, Robert R Recker
There are a number of effective treatments for osteoporosis but most are in the antiresorptive class of compounds. Abaloparatide-SC is a new osteoanabolic agent, which increased bone mineral density and lowered the risk of osteoporosis-related fractures in the phase 3 ACTIVE trial. The objective of this report is to describe the effects of abaloparatide-SC 80μg on bone histology and histomorphometry in iliac crest bone biopsies from this trial in which participants were randomized to receive blinded daily subcutaneous injections of placebo or abaloparatide-SC 80μg/d or open-label teriparatide 20μg/d for 18months...
November 5, 2016: Bone
https://www.readbyqxmd.com/read/27748532/one-year-of-abaloparatide-a-selective-activator-of-the-pth1-receptor-increased-bone-formation-and-bone-mass-in-osteopenic-ovariectomized-rats-without-increasing-bone-resorption
#18
Aurore Varela, Luc Chouinard, Elisabeth Lesage, Susan Y Smith, Gary Hattersley
Abaloparatide is a novel 34-amino acid peptide selected to be a potent and selective activator of the parathyroid hormone receptor (PTH1R) signaling pathway with 41% homology to PTH(1-34) and 76% homology to PTHrP(1-34). A 12-month treatment study was conducted in osteopenic ovariectomized (OVX) rats to characterize the mechanisms by which abaloparatide increases bone mass. Sprague-Dawley (SD) rats were subjected to OVX or sham surgery at age 6 months and left untreated for 3 months to allow OVX-induced bone loss...
January 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/27612281/effects-of-abaloparatide-sc-on-fractures-and-bone-mineral-density-in-subgroups-of-postmenopausal-women-with-osteoporosis-and-varying-baseline-risk-factors
#19
Felicia Cosman, Gary Hattersley, Ming-Yi Hu, Gregory C Williams, Lorraine A Fitzpatrick, Dennis M Black
Abaloparatide-SC is a novel 34-amino acid peptide created to be a potent and selective activator of the parathyroid hormone receptor type 1 (PTHR1) signaling pathway. In the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) Phase 3 trial (NCT01343004), abaloparatide reduced new morphometric vertebral fractures by 86% compared with placebo (p < 0.001) and nonvertebral fractures by 43% (p = 0.049) in postmenopausal women with osteoporosis. Abaloparatide-SC increased bone mineral density (BMD) 3...
January 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/27533157/effect-of-abaloparatide-vs-placebo-on-new-vertebral-fractures-in-postmenopausal-women-with-osteoporosis-a-randomized-clinical-trial
#20
RANDOMIZED CONTROLLED TRIAL
Paul D Miller, Gary Hattersley, Bente Juel Riis, Gregory C Williams, Edith Lau, Luis Augusto Russo, Peter Alexandersen, Cristiano A F Zerbini, Ming-yi Hu, Alan G Harris, Lorraine A Fitzpatrick, Felicia Cosman, Claus Christiansen
IMPORTANCE: Additional therapies are needed for prevention of osteoporotic fractures. Abaloparatide is a selective activator of the parathyroid hormone type 1 receptor. OBJECTIVE: To determine the efficacy and safety of abaloparatide, 80 μg, vs placebo for prevention of new vertebral fracture in postmenopausal women at risk of osteoporotic fracture. DESIGN, SETTING, AND PARTICIPANTS: The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) was a phase 3, double-blind, RCT (March 2011-October 2014) at 28 sites in 10 countries...
August 16, 2016: JAMA: the Journal of the American Medical Association
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