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 Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) Study: 2-Year Nonvertebral Fragility Fracture Results.

Silverman2,  Stuart L., Miller4,  Paul, Sebba1,  Anthony I., Weitz3,  Michael, Wan5,  Xiaohai, Taylor5,  Kathleen, Ruff5,  Valerie

Arthritis Associates, Palm Harbor, FL
Cedars-Sinai Medical Center, University of California Los Angeles, Beverly Hills, CA
Center Arthritis and Rheumatology, South Miami, FL
Colorado Center for Bone Research, Lakewood, CO
Eli Lilly and Company and/or One of Its Subsidiaries, Indianapolis, IN
Lilly USA, LLC, Indianapolis, IN

Statement of Purpose:

To evaluate the occurrence of nonvertebral fragility fractures (NVFX) in subjects treated with teriparatide (TPTD) for osteoporosis (OP) for up to 24 months in a community based setting.

Methods:

The DANCE study is a multi-center, prospective, observational trial designed to examine the long-term effectiveness, safety, and tolerability of TPTD. Patients judged by study physicians to be suitable for TPTD therapy received TPTD 20 mg/day for up to 24 months. The percentage of patients experiencing a new NVFX during 4 TPTD treatment duration periods (table) was calculated. The proportion of patients reporting new NVFX during longer TPTD treatment duration categories was compared to the proportion during TPTD treatment duration of 0 to 6 months using a binomial proportion test. The 0–6 months interval was chosen as the reference since Kaplan-Meier analysis of NVFX in the Fracture Prevention Trial showed that the TPTD and placebo groups appeared to begin to separate after approximately 8 months of study drug.

Results:

The mean TPTD exposure was 17 (95% CI: [16.8, 17.4]) months, and the median TPTD exposure was 23 months. Overall, 115/3649 (3.15%) experienced a NVFX. The incidence of patients experiencing new NVFX during the four TPTD treatment durations was 1.43%, 0.97%, 0.72%, and 0.78%, respectively (table). The incidence of new NVFX during each TPTD treatment duration longer than 6 months was significantly lower than the incidence during TPTD treatment duration 0 to 6 months (p<0.0001). Compared to TPTD treatment of 0 to 6 months, NVFX incidence during treatment durations 6 to 12, 12 to 18, and 18 to 24 months was 32%, 50%, and 45% lower, respectively.

Conclusions:

The results of this observational study indicate that the incidence of new NVFX decreased for patients receiving TPTD treatment for greater than 6 months.

Duration (months)Number of patients with a new NVFXNumber of patients at riskIncidence (%)
>0 to <=65236491.43 (1.04, 1.81)
>6 to <= 122829010.97 (0.61, 1.32)*
>12 to <= 181825060.72 (0.39, 1.05)*
>18 to <= 241721720.78 (0.41, 1.15)*
*p<0.0001 when compared to the 0–6 months study duration period.

To cite this abstract, please use the following information:
Silverman, Stuart L., Miller, Paul, Sebba, Anthony I., Weitz, Michael, Wan, Xiaohai, Taylor, Kathleen, et al; The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) Study: 2-Year Nonvertebral Fragility Fracture Results. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :980
DOI: 10.1002/art.28747

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