Efficacy and safety of oral recombinant calcitonin tablets in postmenopausal women with low bone mass and increased fracture risk: a randomized, placebo-controlled trial

2区 · 医学

Article

作者: H. Bone ; J. P. Gilligan ; D. S. Krause ; N. Binkley

The effect of an investigational oral calcitonin tablet upon bone mineral density (BMD) of the spine was investigated in postmenopausal women with low bone mass and at increased risk of fracture. Compared to placebo, calcitonin tablets increased lumbar spine BMD. This agent may provide an additional choice for patients.INTRODUCTIONAn investigational oral salmon calcitonin preparation was previously shown to increase lumbar spine BMD in postmenopausal women with osteoporosis. Our objective was to evaluate the use of this agent in postmenopausal women with low bone mass and at increased fracture risk but not meeting BMD criteria for osteoporosis.METHODSTreatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year. Dual-energy X-ray absorptiometry was performed at baseline and at study weeks 28 and 54. CTx-1, a bone resorption marker, was obtained at the same time points. Subjects returned periodically for tolerability assessment and adverse event (AE) recording.RESULTSOne hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo. Calcitonin recipients experienced a significant increase from baseline in lumbar spine BMD; the difference compared with placebo was significant. Dosing at bedtime or with dinner was equally effective. CTx-1 was suppressed in calcitonin recipients but not in placebo subjects. Gastrointestinal AEs were common, but the overall safety profile was comparable between groups.CONCLUSIONSOral calcitonin may provide a useful therapeutic alternative for some women with low bone mass.

2013-01-01·Pharmaceutical Patent Analyst

The Oral Delivery of Peptides and Proteins: Established Versus Recently Patented Approaches

Review

作者: Rosenmayr-Templeton, Louise

Over the past 30 years there has been significant research into technologies that promote the delivery of high molecular weight, poor membrane-permeable compounds across the gut. Most work has concentrated on the delivery of peptides and proteins. However, technologies have also been applied to compounds such as poorly membrane-permeable small molecules, heparin and oligonucleotides. Much of this research has been characterized by early promise with many systems showing positive results in animal studies. Success in man has proven more elusive. In 2011, however, the oral delivery of peptides took one step closer to commercial reality when Tarsa Therapeutics announced that it had achieved positive Phase III data for oral recombinant salmon calcitonin. This article reviews the current development status of oral delivery systems for peptides and proteins and examines recent patent activity in this field based mainly on US patents issued in the last 2–3 years.

2012-08-01·Journal of Bone and Mineral Research1区 · 医学

A phase 3 trial of the efficacy and safety of oral recombinant calcitonin: The oral calcitonin in postmenopausal osteoporosis (ORACAL) trial

1区 · 医学

Article

作者: Neil Binkley ; Christine E Buben ; Michael Bolognese ; Tasneem Vally ; Colin Miller ; David S Krause ; Anna Sidorowicz-Bialynicka ; Richard Trout ; James P Gilligan

AbstractThe Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis. A total of 565 women age 46 to 86 (mean 66.5) years were randomized (4:3:2) to receive oral recombinant salmon calcitonin (rsCT) tablets (0.2 mg/d) plus placebo nasal spray, synthetic salmon calcitonin (ssCT) nasal spray (200 IU/d) plus placebo tablets, or placebo (placebo tablets plus placebo nasal spray), respectively for 48 weeks. All women received calcium (≥1000 mg/d) and vitamin D (800 IU/d). Women randomized to oral rsCT had a mean ± SD percent increase from baseline in lumbar spine bone mineral density (BMD) (1.5% ± 3.2%) that was greater than those randomized to ssCT nasal spray (0.78% ± 2.9%) or placebo (0.5% ± 3.2%). Lumbar spine BMD change in those receiving nasal calcitonin did not differ from placebo. Oral rsCT treatment also resulted in greater improvements in trochanteric and total proximal femur BMD than ssCT nasal spray. Reductions in bone resorption markers with oral rsCT were greater than those observed in ssCT nasal spray or placebo recipients. Approximately 80% of subjects in each treatment group experienced an adverse event, the majority of which were mild or moderate in intensity. Gastrointestinal system adverse events were reported by nearly one-half of women in all treatment groups and were the principal reason for premature withdrawals. Less than 10% of women experienced a serious adverse event and no deaths occurred. Overall, oral rsCT was superior to nasal ssCT and placebo for increasing BMD and reducing bone turnover. Oral rsCT was safe and as well tolerated as ssCT nasal spray or placebo. Oral calcitonin may provide an additional treatment alternative for women with postmenopausal osteoporosis. © 2012 American Society for Bone and Mineral Research.

100 项与 Recombinant Salmon Calcitonin(Tarsa Therapeutics) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
骨质疏松症	申请上市	美国	Tarsa Therapeutics, Inc.	2015-07-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00620854 (CTgov)	临床2期	骨质疏松症	24	Oral Tablet	窪遞遞觸願繭簾顧積淵(獵選選蓋簾齋衊淵壓餘) = 淵獵製願願積顧淵夢艱網憲艱製鹹廠蓋積遞網 (選糧淵鏇襯構範襯繭獵, 鹹願範願積顧願範願築 ~ 鏇壓觸膚膚艱獵壓醖鹹)	-	2009-09-24