Primary Endpoint Met in Study of Postmenopausal Women With Osteoporosis Transitioning From Bisphosphonate Treatment
THOUSAND OAKS, Calif. and BRUSSELS, Sept. 1, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced top-line results from the STRUCTURE trial (STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy). The study (NCT01796301) met the primary endpoint, demonstrating a statistically significant difference in favor of romosozumab in the percent change of total hip bone mineral density (measured by DXA) through month 12.
STRUCTURE was a Phase 3, multi-center, international, randomized, open-label, teriparatide-controlled study that evaluated safety, tolerability and efficacy of romosozumab in women with postmenopausal osteoporosis. A total of 436 patients previously treated with bisphosphonate therapy received either subcutaneous romosozumab (210 mg monthly) or subcutaneous teriparatide (20 mcg daily) through to month 12.
The overall subject incidence of adverse events was generally balanced between arms. Adverse events in patients treated with romosozumab were similar to those previously reported and no new safety signals were detected. Adverse events reported in the romosozumab arm in more than five percent of patients were nasopharyngitis, arthralgia, back pain, headache and fall.
Further analysis of the Phase 3 STRUCTURE study results are ongoing and will be submitted to a future medical conference and for publication.
Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program evaluating the safety and efficacy of romosozumab includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal patients with osteoporosis. First results from the Phase 3 study FRAME are expected in H1 2016. Romosozumab is being co-developed by Amgen and UCB.
Osteoporosis affects many women after menopause as their ability to form new bone cannot counter balance the rate at which bone is being removed.1,2 This bone loss leads to weakened bones over time, increasing the potential for a break.3,4
About half of all women over age 50 will have an osteoporosis-related fracture in their remaining lifetime.5 Additionally, patients with a previous hip fracture have a threefold greater risk of a subsequent fracture within two years.6,7
The World Health Organization has officially declared osteoporosis a public health crisis, while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8500 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014. UCB is listed on Euronext Brussels (symbol: UCB).
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1 U.S. Department of Health and Human Services, Office of the Surgeon General. The 2004 Surgeon General's Report on Bone Health and Osteoporosis: What It Means to You. http://www.ncbi.nlm.nih.gov/books/NBK45513/pdf/Bookshelf_NBK45513.pdf. Published October 14, 2004. Accessed August 5, 2015.
2 National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. http://nof.org/files/nof/public/content/file/344/upload/159.pdf. Published January 2010. Accessed August 5, 2015.
3 Chavassieux P, et al. Insights into material and structural basis of bone fragility from diseases associated with fractures: how determinants of the biomechanical properties of bone are compromised by disease. Endocr Rev. 2007;28:151-164.
4 Seeman E, Delmas PD. Bone quality - the material and structural basis of bone strength and fragility. N Engl J Med. 2006;354:2250-2261.
5 American Academy of Orthopedic Surgeons. Osteoporosis and Bone Health. http://www.aaos.org/news/aaosnow/may09/clinical8.asp. Accessed August 5, 2015.
6 Colón-Emeric C, Kuchibhatla M, Pieper C, et al. The contribution of hip fracture to risk of subsequent fractures: data from two longitudinal studies. Osteoporos Int. 2003;14:879-883.
7 Lyles KW, Schenck AP, Colón-Emeric CS. Hip and other osteoporotic fractures increase the risk of subsequent fractures in nursing home residents. Osteoporos Int. 2008;19:1225-1233.