Amgen to present data from several Prolia studies at ASBMR 2011 meeting

Amgen (NASDAQ: AMGN) 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)