Baseline Characteristics and Design of a Prospective Observational Study in the United States and Canada to Evaluate Persistence With Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 224-247-Osteoporosis I
Clinical
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-237
Stuart L Silverman*1, Ethel S Siris2, David L Kendler3, Dea Belazi4, Jacques P Brown5, Deborah T Gold6, E Michael Lewiecki7, Alexandra Papaioannou8, Christine Simonelli9, Irene Ferreira10, Joseph J Pinzone11, Suresh Siddhanti11, Bradley Stolshek11 and Christopher Recknor12
1Cedars-Sinai Bone Center for Excellence, UCLA School of Medicine, and OMC Clinical Research Center, Los Angeles, CA, 2Columbia University Medical Center, New York, NY, 3University of British Columbia, Vancouver, BC, Canada, 4Source Healthcare Analytics, Yardley, PA, 5CHU de Québec Research Centre, Laval University, Québec City, QC, Canada, 6Duke University Medical Center, Durham, NC, 7New Mexico Clinical Research & Osteoporosis Center and University of New Mexico School of Medicine, Albuquerque, NM, 8McMaster University, Hamilton, ON, Canada, 9Health East Osteoporosis Care, Woodbury, MN, 10Amgen Ltd., Cambridge, United Kingdom, 11Amgen Inc., Thousand Oaks, CA, 12United Osteoporosis Centers, Gainesville, GA
Purpose:  Persistence with osteoporosis therapy is important for optimal health outcomes including the reduction of fracture risk.  In a randomized, open-label, cross-over study of postmenopausal women with low bone mineral density (BMD), persistence with subcutaneous injections of denosumab every 6 months was 91% and 97% for women who received denosumab in year 1 or 2, respectively.1  However, persistence with denosumab in routine clinical practice has yet to be determined.  Here, we describe the participant baseline characteristics and design of a prospective observational study to evaluate persistence with denosumab in postmenopausal women with osteoporosis in routine clinical practice in the United States (US) and Canada (CAN).

Methods:  This is an ongoing, multi-center, single-arm, prospective, non-interventional, observational study being conducted in the US and CAN.  Key inclusion criteria include 1) enrollment within 4 weeks following administration of the first denosumab (Prolia®) injection and 2) receipt of denosumab for the treatment of osteoporosis consistent with the local product label.  No clinical procedures, assessments, or changes to routine patient management are required.  Participants will be followed for 24 months after study entry.  Study endpoints include 1) persistence with denosumab at 12 and 24 months, 2) time to non-persistence over 24 months, 3) number of injections received within the allowable window (6 months + 8 weeks from previous injection) over 24 months, 4) medication-taking behavior over 12 and 24 months, and 5) occurrence of serious adverse events.

Results:  There were 935 (632 US; 303 CAN) women who enrolled in the study.  Their baseline characteristics were as follows:  94.8% were white (95.1% US; 94.1% CAN), mean age was 70.8 years (71.9 years US; 68.6 years CAN), mean body mass index was 25.7 kg/m2 (25.4 US; 26.2 CAN), 43.2% (43.5% US; 42.6% CAN) had an osteoporotic fracture at ≥ 50 years of age, and the mean number of comorbidities was 5.0 (5.4 US; 4.2 CAN).  Overall, 92.6% (92.9% US; 92.1% CAN) received prior osteoporosis therapy.  Mean BMD T-scores were –1.9 (–1.9 US; –2.1 CAN) at the lumbar spine and –2.1 (–2.2 US; –1.8 CAN) at the femoral neck.  Physicians prescribed denosumab for the following reasons (a patient might have had ≥ 1 reason):  presence of multiple risk factors for fracture (57.0% US; 48.5% CAN), failure of other osteoporosis therapy (49.2% US; 28.4% CAN), intolerance to other osteoporosis therapy (29.9% US; 36.3% CAN), and history of osteoporotic fracture (28.2% US; 31.7% CAN).  The study results are not available since the trial is ongoing.

Conclusions:  These baseline data provide valuable information regarding the patients who are being prescribed denosumab in routine clinical practice in the US and CAN.  This ongoing, prospective, observational study will provide additional insights regarding persistence with denosumab in postmenopausal women.

1)      Freemantle N, et al. Osteoporos Int. 2012;23:317-326

Disclosure: SLS: Speaker, Amgen, Speaker, Eli Lilly & Company, Speaker, Novartis Pharmaceuticals, Speaker, Pfizer, Inc., Consultant, Amgen, Consultant, Genentech, Inc., Consultant, Eli Lilly & Company, Consultant, Novartis Pharmaceuticals, Consultant, Pfizer, Inc., Principal Investigator, Eli Lilly & Company, Principal Investigator, Pfizer, Inc., Employee, Cedars-Sinai Medical Center. ESS: Coinvestigator, Amgen, Speaker Bureau Member, Amgen, Speaker Bureau Member, Eli Lilly & Company, Advisory Group Member, Eli Lilly & Company, Ad Hoc Consultant, Merck & Co., Advisory Group Member, Merck & Co., Ad Hoc Consultant, Pfizer, Inc., Ad Hoc Consultant, Novartis Pharmaceuticals. DLK: Advisory Group Member, Pfizer, Inc., Principal Investigator, Pfizer, Inc., Speaker, Eli Lilly & Company, Investigator, Eli Lilly & Company, Consultant, Merck & Co., Investigator, Novartis Pharmaceuticals, Consultant, Novartis Pharmaceuticals, Speaker, Novartis Pharmaceuticals, Speaker, Amgen, Investigator, Amgen, Consultant, Amgen, Speaker, Warner Chilcott, Speaker, GlaxoSmithKline, Investigator, Johnson &Johnson. JPB: Investigator, Amgen, Investigator, Eli Lilly & Company, Investigator, Merck & Co., Investigator, Novartis Pharmaceuticals, Investigator, Pfizer, Inc., Investigator, Servier, Investigator, Roche Pharmaceuticals, Investigator, Warner Chilcott, Advisory Group Member, Amgen, Advisory Group Member, Eli Lilly & Company, Advisory Group Member, Merck & Co., Speaker Bureau Member, Amgen, Speaker Bureau Member, Eli Lilly & Company, Speaker Bureau Member, Merck & Co., Speaker Bureau Member, Novartis Pharmaceuticals. DTG: Other activities, please specify:, Amgen, Other activities, please specify:, Eli Lilly & Company. EML: Principal Investigator, Amgen, Principal Investigator, Eli Lilly & Company, Principal Investigator, Merck & Co., Principal Investigator, GlaxoSmithKline, Advisory Group Member, Amgen, Speaker Bureau Member, Amgen, Advisory Group Member, Eli Lilly & Company, Speaker Bureau Member, Eli Lilly & Company, Speaker Bureau Member, Novartis Pharmaceuticals, Advisory Group Member, Merck & Co., Consultant, GlaxoSmithKline, Speaker Bureau Member, Warner Chilcott. AP: Consultant, Amgen, Speaker Bureau Member, Amgen, Researcher, Amgen, Consultant, Eli Lilly & Company, Speaker Bureau Member, Eli Lilly & Company, Researcher, Eli Lilly & Company, Consultant, Merck Frosst Canada, Speaker Bureau Member, Merck Frosst Canada, Researcher, Merck Frosst Canada, Consultant, Novartis Pharmaceuticals, Speaker Bureau Member, Novartis Pharmaceuticals, Researcher, Novartis Pharmaceuticals, Consultant, Pfizer, Inc., Speaker Bureau Member, Pfizer, Inc., Researcher, Pfizer, Inc., Consultant, Warner Chilcott, Speaker Bureau Member, Warner Chilcott, Researcher, Warner Chilcott. CS: Speaker, Eli Lilly & Company, Study Investigator, Eli Lilly & Company, Speaker, Amgen, Study Investigator, Amgen. IF: Employee, Amgen, Employee, Amgen, Employee, Amgen. JJP: Employee, Amgen, Employee, Amgen, Employee, Amgen. SS: Employee, Amgen, Employee, Amgen, Employee, Amgen. BS: Employee, Amgen, Employee, Amgen, Employee, Amgen. CR: , Takeda, Advisory Group Member, Zelos, Advisory Group Member, Dramatic Health, Advisory Group Member, Novartis Pharmaceuticals, Advisory Group Member, Eli Lilly & Company, Speaker, Amgen, Speaker, Novartis Pharmaceuticals. Nothing to Disclose: DB

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: Amgen Inc. sponsored this study.