The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study: 2-year nonvertebral fragility fracture results

Abstract

SummaryThis observational study evaluated the occurrence of nonvertebral fragility fractures (NVFX) in over 4,000 men and women with osteoporosis treated with teriparatide (TPTD). The incidence of new NVFX decreased for patients receiving TPTD treatment for greater than 6 months. No new significant safety findings were observed in this large trial.IntroductionThe Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study evaluated the occurrence of NVFX in patients receiving TPTD for osteoporosis in a real-world setting.MethodsDANCE is a multicenter, prospective, observational trial that examined the long-term effectiveness of TPTD in men and women with osteoporosis whom study physicians judged to be suitable for TPTD therapy. Patients received 20 μg TPTD per day by subcutaneous injection for up to 24 months and were followed for 24 months after treatment cessation. The incidence of patients experiencing a new NVFX, defined as a fracture associated with low trauma, was evaluated during four 6-month periods in both the treatment and cessation phases with >0 to ≤6 months serving as the reference. We also observed the spectrum and occurrence of serious adverse events.ResultsOf the 4,167 patients enrolled, 4,085 took one or more doses of TPTD (safety population); 3,720 were included in the efficacy analysis. The incidence of patients experiencing a NVFX was 1.42, 0.91, 0.70, and 0.81 % for the four treatment periods, respectively, and 0.80, 0.68, 0.33, and 0.33 % for the four periods after treatment cessation. Differences for each period were statistically significant compared with the reference period (first 6-month interval, each p < 0.05). No new significant safety findings were observed.ConclusionsIn this study, the incidence of NVFX decreased for patients receiving TPTD for all three treatment periods >6 months compared to 0 to ≤6 months, and this trend persisted throughout the cessation phase. TPTD was generally well tolerated.

The impact of teriparatide adherence and persistence on fracture outcomes

“…The inverse relationship found in this study between therapy exposure and non-vertebral fracture risk is generally consistent with results reported in TPTD randomized clinical trials and prospective observational studies [13][14][15]. The post hoc analysis of the TPTD pivotal RCT data showed that longer duration of exposure was associated with reduced risk of non-vertebral fractures, where the hazard ratio of TPTD 20 μg/day versus placebo was about 65% at the end of 6 months and decreased 7.6% each month, and by the end of 24 months hazard ratio was about 20% [13].…”

“…For TPTD, a post hoc analysis of the pivotal, randomized clinical trial data reported that longer duration of TPTD decreased the risk of non-vertebral fracture [13]. The association between length of exposure to TPTD and lower risk of fracture has also been reported from observational trials in the USA [14] and in Europe [15]. Similar data on real-world TPTD patients in the USA are lacking, however, as previous research focused on patient characteristics and treatment adherence [16,17].…”

“…The post hoc analysis of the TPTD pivotal RCT data showed that longer duration of exposure was associated with reduced risk of non-vertebral fractures, where the hazard ratio of TPTD 20 μg/day versus placebo was about 65% at the end of 6 months and decreased 7.6% each month, and by the end of 24 months hazard ratio was about 20% [13]. In the U.S. DANCE observational study, the incidence of new nonvertebral fractures fell from 1.41% during the initial 6 months of treatment to 0.8% during months 19-24 [14]. The risk of OR odds ratio, CI confidence interval a Results were adjusted for pre-index covariates for age, sex, geographic region, health insurance plan type, health care provider type, Charlson comorbidity index, bone mineral density (BMD) screening, use of osteoporosis and other medications associated with bone loss and fracture risk, and prevalent fracture clinical fractures in the European Forsteo Observational Study (EFOS) was shown to decline over time, as the odds ratio of fracture in TPTD patients was 0.68 and 0.53 for months 6-12 and 12-18, respectively, compared to treatment within the first 6 months [15].…”

Teriparatide fracture effectiveness in the real world

“…In large observational studies of teriparatide in real-world conditions [4,5] and in another study using this same claims database [6], similar reductions in clinical and nonvertebral fracture risk during teriparatide have been reported, comparing the incidence of fracture early during teriparatide to the incidence of fracture later during teriparatide treatment.…”

Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)

“…However, observational studies on teriparatide treatment for 24 months in patients with the newly approved indications are needed. The Direct Analysis of Non-Vertebral Fractures in Community Experience (DANCE) study has provided evidence of a reduction in nonvertebral fractures during teriparatide treatment for up to 24 months in men and women with osteoporosis in the United States 22 .…”