"The continued need for new alternatives to treat postmenopausal osteoporosis is reinforced by data that will be presented at this year's ASBMR meeting. These data highlight challenges with adherence to therapy and show the link between adherence and fracture outcomes," said
ASBMR abstracts are available and can be viewed online at www.asbmr.org. Identified below are selected abstracts of interest on
-- Effects of Denosumab on Bone Mineral Density and Biochemical Markers of Bone Turnover: 6 Year Results of a Phase 2 Clinical Trial
Lead Author: Miller P
Abstract No. 1026 (
-- Effects of Denosumab on Bone Histomorphometry: the FREEDOM and STAND Studies Lead Author: Reid IR
Abstract No. 1027 (
-- Effect of Denosumab on the Incidence of Hip, New Vertebral, and Nonvertebral Fractures Over 3 Years Among Postmenopausal Women with Higher Fracture Risk: A Subgroup Analysis From the FREEDOM Study
Lead Author: Boonen S
Abstract No. 1199 (
-- Effects of Denosumab Treatment and Discontinuation on Bone Mineral Density and Bone Turnover Markers in Postmenopausal Women With Low Bone Mass
Lead Author: Bone H
Abstract No. 1243 (
-- Baseline Remodeling Intensity and Greater Suppression by Denosumab Than Alendronate: Effects on HR-pQCT Parameters at the Radius
Lead Author: Seeman SE
Abstract No. 1244 (
-- Evaluation of Health-Related Quality of Life in Postmenopausal Women Who Participated in the FREEDOM Trial
Lead Author: Siris E
Abstract No. 1282 (
-- Increases in BMD on Denosumab Explains Much of the Reduction in Fracture Risk
Lead Author: Cummings SR
Abstract No. 1284 (
Osteoporosis Burden and Treatment Challenges
-- Impact of Treatment Satisfaction (Perceived Benefits, Convenience, Side Effects) on Persistence with Postmenopausal Osteoporosis (PMO) Therapy
Lead Author: Do T
Abstract No. SA0317 (
-- Impact of Adherence to Osteoporosis Medication on Risk of Fracture
Lead Author: Halpern R.
Abstract No. SA0368 (
-- Association Between Adherence to Osteoporosis Medication and Inpatient Stays and Medical Services Costs
Lead Author: Iqbal SU
Abstract No. SU0387 (
-- Comorbidities, Bone Loss and Concomitant Medication Use in European Postmenopausal Women: POSSIBLE EU
Lead Author: Freemantle N
Abstract No. MO0369 (
-- Assessment of Patient Preference, Satisfaction, and Bother with Two Treatments For Postmenopausal Bone Loss
Lead Author: Gold DT
Abstract No. MO0369 (
About Prolia(TM) (denosumab)
Prolia is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Prolia is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Prolia is being studied in a range of bone loss conditions including postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.
Osteoporosis: Impact and Prevalence
Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages.
The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(i,ii,iii) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(iv)
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In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
i. Burge R, et al. J Bone Miner Res. 2007; 22:465-475
ii. "Osteoporosis Fast Facts."
iii. "Economic Cost of Cardiovascular Diseases."
iv. Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in switzerland."