Comparison of Efficacy of PTH analogue and other therapy on the prevention of subsequent vertebral compression fracture after percutaneous vertebroplasty in patients with high risk for subsequent vertebral compression fracture: prospective comparative analysis between PTH analogue-treated group and other therapy (bisphosphonate, SERM)-treated group

开始日期2019-05-23

申办/合作机构-

NCT01321723 / Completed临床2期

A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis

This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

开始日期2011-02-01

申办/合作机构

Unigene Laboratories, Inc.

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项与 Parathyroid hormone analog(Unigene Laboratories, Inc.) 相关的文献（医药）

2023-12-01·Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS)

Article

作者: Cheng, Q ; Zhao, Y-Z ; Shi, X ; Zou, S-P ; Sun, M-H

INTRODUCTION:

We investigated 33,480(0.14%) ABL-related adverse events (AEs) through data mining of Food and Drug Administration Adverse Event Reporting System (FAERS) retrospectively.

METHODS:

Reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) were employed to quantify the signals of ABL-related AEs from 2017Quarter2 to 2022.Serious and non-serious cases were compared by Mann-Whitney U test or Chi-squared (χ²) test.

RESULTS:

We collected 8,470,497 reports from the FAERS database, including 11,487 reports defined ABL as the primary suspected (PS) drug. Additionally, 36.16% of the reports were submitted by healthcare professionals (n=4154), compared to 62.26% reported by consumers (n=7140). A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals. Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13). Patient age (p < 0.001) might be associated with an increased risk of AEs severity. The most common timeframe for AE occurrence was 0-7 days.

CONCLUSION:

Our study provided a deeper and broader understanding of abaloparatide's safety profiles, which would help healthcare professionals to mitigate the risk of AEs in clinical practice, a low number of unexpected AEs supporting ongoing additional pharmacovigilance.

2023-11-01·Obstetrical & gynecological survey

Diagnosis and Management of Osteoporosis: A Comprehensive Review of Guidelines

Review

作者: Dagklis, Themistoklis ; Athanasiadis, Apostolos ; Kalogiannidis, Ioannis ; Rentzeperi, Elpiniki ; Pegiou, Stavroula ; Tsakiridis, Ioannis ; Kourtis, Anargyros ; Mamopoulos, Apostolos

Importance:

Osteoporosis causes increased morbidity and mortality, and thus poses a significant economic burden to the health systems worldwide.

Objective:

The aim of this study was to review and compare the most recently published major guidelines on diagnosis and management of this common medical entity.

Evidence Acquisition:

A thorough comparative review of the most influential guidelines from the RACGP (Royal Australian College of General Practitioners), the ESCEO-IOF (European Society for Clinical and Economic Aspects of Osteoporosis–International Osteoporosis Foundation), the NOGG (National Osteoporosis Guideline Group), the NAMS (North American Menopause Society), the ES (Endocrine Society), and the ACOG (American College of Obstetricians and Gynecologists) was conducted.

Results:

The reviewed guidelines generally agree on the definition, the criteria, and investigations used to diagnose osteoporosis. They also concur regarding the risk factors for osteoporosis and the suggested lifestyle modifications (calcium and vitamin D intake, normal body weight, reduction of alcohol consumption, and smoking cessation). However, there is lack of consensus on indications for fracture risk assessment in the general population and the exact indications for bone mineral density assessment. Referral to a bone specialist is reserved for complex cases of osteoporosis (NOGG, NAMS, and ACOG) or in case of inadequate access to care (RACGP). The use of hip protectors to reduce the risk of fractures is supported by RACGP, NOGG, and NAMS, solely for high-risk elderly patients in residential care settings. All guidelines reviewed recognize the efficacy of the pharmacologic agents (ie, bisphosphonates, denosumab, hormone therapy, and parathyroid hormone analogs). Nonetheless, recommendations regarding monitoring of pharmacotherapy differ, primarily in the case of bisphosphonates. The proposed intervals of repeat bone mineral density testing after initiation of drug therapy are set at 2 years (RACGP), 1–3 years (NAMS, ES, and ACOG), or 3–5 years (ESCEO-IOF and NOGG). All guidelines agree upon the restricted use of bone turnover markers only in bone specialist centers for treatment monitoring purposes. Finally, the definition of treatment failure varies among the reviewed guidelines.

Conclusions:

Osteoporosis is a distressing condition for women, mainly those of postmenopausal age. Thus, it seems of paramount importance to develop consistent international practice protocols for more cost-effective diagnostic and management techniques, in order to improve women's quality of life.

Target Audience:

Obstetricians and gynecologists, family physicians.

Learning Objectives:

After participating in this activity, the physician should be able to identify early risk factors for osteoporosis; describe the appropriate diagnostic techniques for osteoporosis; and explain available drug agents for the management of osteoporosis, as well as the difference in approach regarding their use.

2023-02-23·Cureus

A Novel Homozygous Mutation of AIRE Gene in a Patient With Autoimmune Polyglandular Syndrome Type I

作者: Tautiva-Rojas, Camila M ; Bogarin-Solano, Roberto ; Santamaría-Quesada, Carlos ; Pacheco-Muñoz, Mariana

Autoimmune polyglandular syndrome type I (APS1) shows common features such as mucocutaneous candidiasis, hypoparathyroidism, and hypoadrenalism. The clinical manifestations and their onset are highly variable. Besides endocrine abnormalities, patients can present with dental problems, keratoconjunctivitis, fever, rash, chronic diarrhea, and autoimmune hepatitis. We discuss the case of a 5-year-old female who presented initially with a new-onset seizure due to severe hypocalcemia and was diagnosed with primary hypoparathyroidism. Because she also had a history of chronic mucocutaneous candidiasis, chronic diarrhea, and the presence of autoantibodies tested positive, the diagnosis of APS1 was suspected. Genetic testing detected a novel pathogenic homozygous AIRE mutation, which confirmed the diagnosis. She began multidisciplinary treatment with antifungals, calcium supplements, and parathyroid hormone analogs.

项与 Parathyroid hormone analog(Unigene Laboratories, Inc.) 相关的新闻（医药）

2023-04-26

·GlobeNewswire-Health Care

Menopause Luminary, Dr. Steven R. Goldstein, Joins Entera’s Clinical and Scientific Advisory Board

JERUSALEM, April 26, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today announced that Steven R. Goldstein, MD, Professor of Obstetrics and Gynecology at New York University School of Medicine and former President of The International Menopause Society, the North American Menopause Society and recipient of the Clarkson Award from NAMS for lifetime achievement in menopause research will be joining its Clinical and Scientific Advisory Board (CSAB). “We are thrilled to welcome Dr. Goldstein, a world-renowned leader in menopause and women’s health, to our CSAB and look forward to working with him along with our esteemed endocrinology experts at this critical time for our EB613 program. Gynecologists remain primary care for the millions of women in or post-menopause globally and the importance of actively managing bone health is paramount to their well-being. As potentially the first oral osteoanabolic therapy for post-menopausal women, EB613 is being developed to fulfill this promise,” stated Miranda Toledano, Chief Executive Officer of Entera. “Osteoporosis is becoming one of the biggest medical problems of our aging population. In the U.S. for hip fractures alone, 21% of women who suffer a hip fracture will be dead within a year even after it is surgically repaired. Without surgery, the one-year mortality rate is about 70%1. Unfortunately, much of the undertreatment of osteoporosis and the missed opportunity to reduce fractures stems from lack of oral anabolic agents. The fact that such agents require injection (either daily or monthly) causes large numbers of women to go under treated. An oral PTH analogue would be extremely useful in helping so many of these women,” stated Dr. Steven R. Goldstein. About Entera Bio Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a daily mini tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company’s most advanced product candidates, EB613 for the treatment of high risk, post-menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. Both EB612 and EB613 are being developed to address undertreated diseases which disproportionately afflict women. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo®, a mainstay anabolic treatment which requires daily SC injections. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH formulations is planned for H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in JBMR 2019) and for another potential indication. For more information on Entera Bio, visit www.enterabio.com. Cautionary Statement Regarding Forward Looking Statements Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera’s agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. _______________________________________ 1 Mundi S, Pindiprolu B, Simunovic N, Bhandari M. Similar mortality rates in hip fracture patients over the past 31 years: a systematic review of RCTs. Acta Orthopaedica. 2014;85(1):54-9. doi:10.3109/17453674.2013.878831

临床2期临床1期临床结果

2022-12-21

·PipelineReview

Radius Health's TYMLOS (abaloparatide) Receives U.S. FDA Approval as a Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture

CAMBRIDGE, MA, USA I December 20, 2022 I Radius Health, Inc. ("Radius" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved TYMLOS ® (abaloparatide), a parathyroid hormone related peptide [PTHrP(1‑34)] analog, as a treatment to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or in patients who have failed or are intolerant to other available osteoporosis therapy. 1 This approval is based on the Phase 3 ATOM study ("Abaloparatide Treatment of Men; BA058-05-019"), which was a randomized, double-blind, placebo-controlled, 12-month multicenter study designed to evaluate the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis. 1 The primary efficacy endpoint of the ATOM study was the percent change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months, which was 8.5% and 1.2% in abaloparatide and placebo groups, respectively. 1 This treatment difference between abaloparatide and placebo was 7.3% (99% CI: 5.1%, 9.6%; p<0.0001). 1 Osteoporosis-related fractures are an important health concern because of related morbidity, mortality, and cost. 2 Bruce Mitlak, M.D., the Chief Medical Officer of Radius, emphasized that "30% of all hip fractures occur in men and approximately 25% of men over the age of 50 years will sustain an osteoporotic-related fracture. Additionally, while the overall prevalence of fragility fractures is higher in women, men generally have higher rates of fracture-related mortality." 2,3,4 "TYMLOS has been helping postmenopausal women with osteoporosis at high risk for fracture for over five years. We are excited that with this approval, we can bring TYMLOS to a new population," said Chhaya Shah, Chief Business Officer at Radius. 1 "We are grateful to the men who participated in the ATOM study, as they played a pivotal role in helping bring this important treatment to men with osteoporosis at high risk of fracture." TYMLOS was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, based on the Phase 3 ACTIVE study. 1 Abaloparatide met the primary efficacy endpoint with a statistically significant relative risk reduction of new vertebral fracture at Month 18 versus placebo (0.6% versus 4.2%, respectively, p<0.0001). 1 There was an 86% relative risk reduction in new vertebral fractures in postmenopausal women receiving abaloparatide versus placebo. 1 The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%). 1 The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%). 1 Please see the detailed Important Safety Information provided below for more important safety information. "Radius stands behind our commitment to the bone health community and with this approval, men with osteoporosis at high risk for fracture will have an additional important treatment option," said Scott Briggs, Chief Executive Officer at Radius. IMPORTANT SAFETY INFORMATION 1 Contraindications: TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria. Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget's disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma. Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary. Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia. Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Pregnancy and Lactation: TYMLOS is not indicated for use in females of reproductive potential. Adverse Reactions: Please see full Prescribing Information . About Abaloparatide 1 Abaloparatide (TYMLOS ® ) was approved in April 2017 by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures. Abaloparatide is supplied as a single-patient multi-use prefilled pen designed to subcutaneously administer 80 micrograms per dose over a 30-day period. About ATOM Phase 3 Study 1 The ATOM pivotal Phase 3 study, Study BA058-05-019, was a randomized, double-blind, placebo-controlled study in 228 men with osteoporosis to assess efficacy and safety of abaloparatide injection. Subjects were randomized in a 2:1 treatment ratio to receive subcutaneous administration of either abaloparatide 80 micrograms or placebo for 12 months to determine the effect of abaloparatide on lumbar spine bone mineral density (BMD) and other bone health-related endpoints. The primary efficacy endpoint was the percent change from baseline in BMD at the lumbar spine at 12 months. Key secondary efficacy endpoints included the percent change from baseline in BMD at the total hip and femoral neck at 12 months. 5 About the ACTIVE Phase 3 Study 1 The ACTIVE pivotal Phase 3 fracture prevention trial (Abaloparatide Comparator Trial in Vertebral Endpoints; Study BA058-05-003) was a randomized, double-blind, placebo-controlled trial in 2,463 postmenopausal osteoporotic women randomized to receive daily doses of one of the following for 18 months: 80 ug of abaloparatide; a matching placebo; or the approved dose of 20 ug of teriparatide. Study medication was self-administered daily by subcutaneous injection for a maximum of 18 months. The primary efficacy endpoint was the number of patients treated with abaloparatide-SC with incident vertebral fractures at the end of treatment as compared to those who received placebo. The pre-specified secondary efficacy parameters included, among other endpoints, reduction in the incidence of non-vertebral fractures; changes in BMD of the spine, hip, and femoral neck from baseline to end of treatment as assessed by DXA and as compared to teriparatide; and the number of hypercalcemic events in abaloparatide-SC treated patients when compared to teriparatide at end of treatment. 6 About Osteoporosis Osteoporosis is a bone disorder that occurs with aging and is associated with reduced bone density, compromised bone strength, and impaired bone quality, resulting in an increased risk of fractures. 7 About Radius Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health and oncology. Radius' lead product, TYMLOS ® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 for the treatment of men with osteoporosis at high risk for fracture. The Radius clinical pipeline includes the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group. 1. TYMLOS [prescribing information]. Boston, MA: Radius Health, Inc. 2. Sözen T, Özışık L, Başaran NÇ. An overview and management of osteoporosis. Eur J Rheumatol. 2017 Mar;4(1):46-56. doi: 10.5152/eurjrheum.2016.048. Epub 2016 Dec 30. 3. Willson T, Nelson S, Newbold J, LaFleur J. The clinical epidemiology of male osteoporosis: a review of recent literature. Clin Epidemiol. 2015 Jan 9. 4. Cauley JA, Cawthon PM, Peters KE, Cummings SR, Ensrud KE, Bauer DC, Taylor BC, Shikany JM, Hoffman AR, Lane NE, Kado DM, Stefanick ML, Orwoll ES. Osteoporotic Fractures in Men (MrOS) Study Research Group. Risk Factors for Hip Fracture in Older Men: The Osteoporotic Fractures in Men Study (MrOS). J Bone Miner Res. 2016 Oct. 5. Czerwinski E, Cardona J, Plebanski R, Recknor C, Vokes T, Saag KG, Binkley N, Lewiecki EM, Adachi J, Knychas D, Kendler D, Orwoll E, Chen Y, Pearman L, Li YH, Mitlak B. The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial. J Bone Miner Res. 2022 Oct 3. 6. Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016;316(7):22-33 [published correction appears in JAMA. 2017;317(4):442]. 7. About Osteoporosis. Osteoporosis Foundation. Available at: https://www.osteoporosis.foundation/patients/about-osteoporosis . SOURCE: Radius Health

临床3期临床结果上市批准

2022-12-20

·PRNewswire

Radius Health's TYMLOS® (abaloparatide) Receives U.S. FDA Approval as a Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture

CAMBRIDGE, Mass., Dec. 20, 2022 /PRNewswire/ -- Radius Health, Inc. ("Radius" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved TYMLOS® (abaloparatide), a parathyroid hormone related peptide [PTHrP(1‑34)] analog, as a treatment to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or in patients who have failed or are intolerant to other available osteoporosis therapy.1 This approval is based on the Phase 3 ATOM study ("Abaloparatide Treatment of Men; BA058-05-019"), which was a randomized, double-blind, placebo-controlled, 12-month multicenter study designed to evaluate the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis.1 The primary efficacy endpoint of the ATOM study was the percent change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months, which was 8.5% and 1.2% in abaloparatide and placebo groups, respectively.1 This treatment difference between abaloparatide and placebo was 7.3% (99% CI: 5.1%, 9.6%; p<0.0001).1 Osteoporosis-related fractures are an important health concern because of related morbidity, mortality, and cost.2 Bruce Mitlak, M.D., the Chief Medical Officer of Radius, emphasized that "30% of all hip fractures occur in men and approximately 25% of men over the age of 50 years will sustain an osteoporotic-related fracture. Additionally, while the overall prevalence of fragility fractures is higher in women, men generally have higher rates of fracture-related mortality."2,3,4 "TYMLOS has been helping postmenopausal women with osteoporosis at high risk for fracture for over five years. We are excited that with this approval, we can bring TYMLOS to a new population," said Chhaya Shah, Chief Business Officer at Radius.1 "We are grateful to the men who participated in the ATOM study, as they played a pivotal role in helping bring this important treatment to men with osteoporosis at high risk of fracture." TYMLOS was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, based on the Phase 3 ACTIVE study.1 Abaloparatide met the primary efficacy endpoint with a statistically significant relative risk reduction of new vertebral fracture at Month 18 versus placebo (0.6% versus 4.2%, respectively, p<0.0001).1 There was an 86% relative risk reduction in new vertebral fractures in postmenopausal women receiving abaloparatide versus placebo.1 The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%).1 The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).1 Please see the detailed Important Safety Information provided below for more important safety information. "Radius stands behind our commitment to the bone health community and with this approval, men with osteoporosis at high risk for fracture will have an additional important treatment option," said Scott Briggs, Chief Executive Officer at Radius. IMPORTANT SAFETY INFORMATION1 Contraindications: TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria. Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget's disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma. Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary. Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia. Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Pregnancy and Lactation: TYMLOS is not indicated for use in females of reproductive potential. Adverse Reactions: The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%). The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%). Please see full Prescribing Information. About Abaloparatide1 Abaloparatide (TYMLOS®) was approved in April 2017 by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures. Abaloparatide is supplied as a single-patient multi-use prefilled pen designed to subcutaneously administer 80 micrograms per dose over a 30-day period. About ATOM Phase 3 Study1 The ATOM pivotal Phase 3 study, Study BA058-05-019, was a randomized, double-blind, placebo-controlled study in 228 men with osteoporosis to assess efficacy and safety of abaloparatide injection. Subjects were randomized in a 2:1 treatment ratio to receive subcutaneous administration of either abaloparatide 80 micrograms or placebo for 12 months to determine the effect of abaloparatide on lumbar spine bone mineral density (BMD) and other bone health-related endpoints. The primary efficacy endpoint was the percent change from baseline in BMD at the lumbar spine at 12 months. Key secondary efficacy endpoints included the percent change from baseline in BMD at the total hip and femoral neck at 12 months.5 About the ACTIVE Phase 3 Study1 The ACTIVE pivotal Phase 3 fracture prevention trial (Abaloparatide Comparator Trial in Vertebral Endpoints; Study BA058-05-003) was a randomized, double-blind, placebo-controlled trial in 2,463 postmenopausal osteoporotic women randomized to receive daily doses of one of the following for 18 months: 80 ug of abaloparatide; a matching placebo; or the approved dose of 20 ug of teriparatide. Study medication was self-administered daily by subcutaneous injection for a maximum of 18 months. The primary efficacy endpoint was the number of patients treated with abaloparatide-SC with incident vertebral fractures at the end of treatment as compared to those who received placebo. The pre-specified secondary efficacy parameters included, among other endpoints, reduction in the incidence of non-vertebral fractures; changes in BMD of the spine, hip, and femoral neck from baseline to end of treatment as assessed by DXA and as compared to teriparatide; and the number of hypercalcemic events in abaloparatide-SC treated patients when compared to teriparatide at end of treatment.6 About Osteoporosis Osteoporosis is a bone disorder that occurs with aging and is associated with reduced bone density, compromised bone strength, and impaired bone quality, resulting in an increased risk of fractures.7 About Radius Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health and oncology. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 for the treatment of men with osteoporosis at high risk for fracture. The Radius clinical pipeline includes the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group. 1. TYMLOS [prescribing information]. Boston, MA: Radius Health, Inc. 2. Sözen T, Özışık L, Başaran NÇ. An overview and management of osteoporosis. Eur J Rheumatol. 2017 Mar;4(1):46-56. doi: 10.5152/eurjrheum.2016.048. Epub 2016 Dec 30. 3. Willson T, Nelson S, Newbold J, LaFleur J. The clinical epidemiology of male osteoporosis: a review of recent literature. Clin Epidemiol. 2015 Jan 9. 4. Cauley JA, Cawthon PM, Peters KE, Cummings SR, Ensrud KE, Bauer DC, Taylor BC, Shikany JM, Hoffman AR, Lane NE, Kado DM, Stefanick ML, Orwoll ES. Osteoporotic Fractures in Men (MrOS) Study Research Group. Risk Factors for Hip Fracture in Older Men: The Osteoporotic Fractures in Men Study (MrOS). J Bone Miner Res. 2016 Oct. 5. Czerwinski E, Cardona J, Plebanski R, Recknor C, Vokes T, Saag KG, Binkley N, Lewiecki EM, Adachi J, Knychas D, Kendler D, Orwoll E, Chen Y, Pearman L, Li YH, Mitlak B. The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial. J Bone Miner Res. 2022 Oct 3. 6. Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016;316(7):22-33 [published correction appears in JAMA. 2017;317(4):442]. 7. About Osteoporosis. Osteoporosis Foundation. Available at: . ©2022 Radius Health, Inc. TYMLOS is a registered trademark of Radius Health Inc. TYM-US-05232 12/22 SOURCE Radius Health, Inc.

临床结果临床3期上市批准

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适应症	最高研发状态	国家/地区	公司	日期
绝经期后骨质疏松	临床2期	丹麦	GSK Plc	2011-02-01
绝经期后骨质疏松	临床2期	丹麦	Unigene Laboratories, Inc.	2011-02-01
绝经期后骨质疏松	临床2期	爱沙尼亚	Unigene Laboratories, Inc.	2011-02-01
绝经期后骨质疏松	临床2期	爱沙尼亚	GSK Plc	2011-02-01