Amgen today announced that it will present data from several Prolia® (denosumab) studies, including eight year efficacy and safety data from a Phase 2 extension study in women with postmenopausal osteoporosis with low bone mineral density (BMD), at the 2011 American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego, Calif. from Sept. 16-20, 2011.
"The breadth of data being presented at this year's Annual Meeting demonstrates Amgen's continued commitment to advancing the scientific understanding of bone biology," said Catherine Stehman-Breen, M.D., vice president of Global Development at Amgen. "Importantly, the eight year data from our Phase 2 extension study supports the long-term efficacy and safety profile of Prolia for women with postmenopausal osteoporosis at increased risk of fractures."
ASBMR abstracts are available and can be viewed online at www.asbmr.org. Identified below are selected abstracts of interest on Amgen research.
Oral Presentations
Effects of Denosumab on Bone Mineral Density and Biochemical Markers of Bone Turnover: 8 Year Results of a Phase 2 Clinical Trial
Lead Author: Michael R. McClung M.D. FACP FACE, Oregon Osteoporosis Center
Abstract No. 1061, Oral Presentation
(Saturday, Sept. 17, 2:15 p.m. – 2:30 p.m. PT)
Effects of Denosumab on Radius BMD, Strength, and Wrist Fractures: Results From the Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) Study
Lead Author: James Simon M.D., George Washington University
Abstract No. 1062, Oral Presentation
(Saturday, Sept. 17, 2:30 p.m. – 2:45 p.m. PT)
Efficacy of Five Years of Denosumab: A Novel "Virtual Twins" Method for Minimizing Bias in Extensions of Trials
Lead Author: Steven R. Cummings M.D., University of California, San Francisco
Abstract No. 1063, Oral Presentation
(Saturday, Sept. 17, 2:45 p.m. – 3:00 p.m. PT)
The Transitory Increase in PTH Following Denosumab Administration is Associated with Reduced Intracortical Porosity: a Distinctive Attribute of Denosumab Therapy
Lead Author: Prof. Ego Seeman, Austin Health, University of Melbourne
Abstract No. 1064, Oral Presentation
(Saturday, Sept. 17, 3:00 p.m. – 3:15 p.m. PT)
Safety Observations From Denosumab Long-term Extension and Cross-over Studies in Postmenopausal Women With Osteoporosis
Lead Author: Henry G. Bone M.D., Michigan Bone and Mineral Clinic
Abstract No. 1065, Oral Presentation
(Saturday, Sept. 17, 3:15 p.m. – 3:30 p.m. PT)
Poster Presentations
Rates of Diagnosis and Treatment of Osteoporosis in Males Before and After Hip, Vertebral, and Non-Hip/Non-Vertebral (NHNV) Fractures
Lead Author: Susan K. Brenneman, PT Ph.D., Innovus
Abstract No. SA0445, Poster Presentation
(Saturday, Sept. 17, 11:00 a.m. – 1:00 p.m. PT)
Medication Adherence in Patients on Osteoporosis Therapy: Physician Perceptions Versus Patient Behavior
Lead Author: Cai Q, HealthCore
Abstract No. SU0443, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)
Discontinuation of Denosumab and Associated Fracture Incidence: Analysis From the FREEDOM Trial
Lead Author: Jacques P. Brown M.D., CHUQ-CHUL Research Centre
Abstract No. SA0446, Plenary Poster Presentation
(Saturday, Sept. 17, 11:00 a.m. – 1:00 p.m. PT)
The Effect of Denosumab on the Bone Matrix Mineralization in Mice
Lead Author: Barbara M. Misof, Ph.D., Ludwig Boltzmann Institute of Osteology at Hanusch Hospital
Abstract No. SA0058, Plenary Poster Presentation
(Saturday, Sept. 17, 11:00 a.m. – 1:00 p.m. PT)
Adherence to Osteoporosis Medications in Men: A Systematic Review of the Literature
Lead Author: Robyn VonMaltzahn, HERON Evidence Development Ltd.
Abstract No. SU0442, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)
Development of a Comorbidity Index Using the FREEDOM Trial in Women with Postmenopausal Osteoporosis
Lead Author: Neil S. Silverman M.D., Cedar-Sinai Medical Center
Abstract No. SU0455, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)
Psychometric Properties of the Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS) in Postmenopausal Women With Osteoporosis (OP) Treated with Bisphosphonates (BP)
Lead Author: Kristi Reynolds, Ph.D., MPH, Kaiser Permanente Southern California
Abstract No. SU0439, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)
Persistence, Gaps in Therapy, and Re-initiation of Osteoporosis (OP) Therapy Among Women in a Commercially Insured US Population
Lead Author: Akhila Balasubramanian, Ph.D., Amgen Inc.
Abstract No. MO0435, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)
Healthcare Costs for Males After Closed Fracture in Commercially Insured and Medicare Advantage Populations From a National Health Plan
Lead Author: Susan K. Brenneman, PT Ph.D., Innovus
Abstract No. MO0441, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)
Associations Between Osteoporosis (OP) Treatment Change, Adherence, and Incident Fractures Among Members in a Medicare Advantage Prescription Drug (MAPD) Plan
Lead Author: Yihua Xu, Ph.D., Competitive Health Analytics, Inc.
Abstract No. MO0429, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)
A Phase 3 Study of the Efficacy and Safety of Denosumab in Men with Low Bone Mineral Density: Design of the ADAMO Trial
Lead Author: Eric Orwoll M.D., Oregon Health and Science University
Abstract No. MO0442, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)
Osteoporosis: Impact and Prevalence
Referred to as a "silent epidemic" by the International Osteoporosis Foundation (IOF), osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization has officially declared osteoporosis a public health crisis, and the IOF is urging governments worldwide to make osteoporosis a healthcare priority.
Osteoporosis-associated fractures are a significant cause of mortality and morbidity. In 2000, the number of osteoporotic fractures in Europe was estimated at 3.79 million, of which 890,000 were hip fractures.(i) Since 2001, the incidence of hip fractures in European countries has risen significantly.(ii) In the United States (U.S.), the number of fractures due to osteoporosis is expected to rise to more than three million by 2025. (iii)
The direct medical cost of osteoporotic fractures in Europe is expected to rise from euro 31.7 billion in 2000 to euro 76.7 billion in 2050.(iv) In 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in cost in the U.S., and this cost is expected to rise to approximately $25 billion by 2025. (v)
About Prolia
Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).
Prolia is approved in the U.S. 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.
Prolia is approved in the European Union (EU) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
Prolia is approved in 20 European countries, the U.S., Canada and Australia. Applications in the rest of the world are pending.
Prolia is administered as a single subcutaneous injection of 60mg once every six months. For further information on Prolia, including prescribing information and medication guide, please visit: www.prolia.com.
