Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.

The Effects of Denosumab (DMAb) on Bone Mineral Density (BMD), Fracture and Safety Outcomes by Level of Renal Function.

Jamal8,  Sophie A., Ebeling7,  Peter R., Ljunggren9,  Osten, Stehman-Breen1,  Catherine, Cummings5,  Steven R., McClung4,  Michael R., Goemaere3,  Stefan

Amgen Inc., Thousand Oaks, CA
Central Clinical Hospital, Warsaw, Poland
Ghent University Hospital, Belgium
Oregon Osteoporosis Center, Portland, OR
San Francisco Coordinating Center, CPMC Research Institute and University of California, San Francisco, San Francisco, CA
University of Colorado Health Sciences Center, CO
University of Melbourne, Melbourne, Australia
University of Toronto, Toronto, ON, Canada
Uppsala University Hospital, Sweden

Treatments for osteoporosis in patients with renal impairment, both common conditions in the older population are limited. DMAb is not excreted by the kidney and is a potential treatment option.

The efficacy and safety of DMAb given as a 60 mg s.c injection every 6 months for 3 years among patients in Phase 3 FREEDOM Study was evaluated. Creatinine clearance (CrCl) was estimated using the Cockcroft-Gault equation. A subgroup interaction term was used to assess differences in treatment effect by CrCl. We examined incident fracture rates, changes in BMD, serum calcium, serum creatinine and the incidence of adverse events after 36 months of follow-up in subjects receiving DMAb and placebo, stratified by level of renal function using linear regression models adjusted for multiple baseline characteristics including prevalent vertebral fractures and years since menopause.

Most (97%) women were Caucasian, the mean age was 72.3 ±5.2 years, the mean weight was 63.8 ± 10.4 kg, serum creatinine was 70.8 ± 15.3mmol/L and serum calcium was 2.44 ±0.11mmol/L. Subject disposition by level of renal function was balanced between DMAb and placebo treated subjects. 73 women had a CrCl between 15 to 29ml/min (CKD stage 4); 2817 between 30 to 59 mL//min (CKD stage 3); 4069 between 60 to 89 mL/min (CKD stage 2) and 842 had a CrCl of >= 90 mL/min (CKD stage 1/normal). Vertebral and non-vertebral fracture risk reduction and differences in the percent change in BMD at all sites were in favour of DMAb. The test for treatment by subgroup interaction indicated that fracture risk reduction was not statistically different by level of renal function. The difference in the mean % changes in BMD in subjects treated with DMAb compared with placebo did not differ by level of renal function. Changes in serum creatinine, serum calcium and the incidence of adverse, serious adverse and fatal events were similar between the treatment groups and did not differ by level of renal function.

DMAb reduces fracture risk and is not associated with an overall increase in adverse events among patients with impaired kidney function.

To cite this abstract, please use the following information:
Jamal, Sophie A., Ebeling, Peter R., Ljunggren, Osten, Stehman-Breen, Catherine, Cummings, Steven R., McClung, Michael R., et al; The Effects of Denosumab (DMAb) on Bone Mineral Density (BMD), Fracture and Safety Outcomes by Level of Renal Function. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :982
DOI: 10.1002/art.28749

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