Fractures after Initiation of a Drug Holiday in a Real- Life Setting

Purpose: We aimed to assess the fracture rate in patients who were placed on a drug holiday (DH) after minimum adequate therapy versus those who continued therapy (CT) in a real-life setting. Methods: This is a retrospective cohort study conducted in a tertiary academic center. Inclusion criteria involved osteoporotic adults who received minimum adequate bisphosphonate therapy (≥ 3 years), otherwise, patients were excluded. Results: Of 1,814 charts randomly selected and reviewed, 272 patients met the inclusion criteria. In our cohort, females were 90.9%, White 50.0%, and African American 40.5%. A DH was initiated in 119 patients (43.8%). In the CT versus DH cohorts, the mean duration of therapy was 6.0 ± 2.6 versus 5.7 ± 2.3 years, total duration of follow-up 6.9 ± 2.9 versus 7.8 ± 2.7 years, and fractures occurred in 11.7% versus 9.2% respectively, not statistically different. The mean duration of follow-up after starting DH was 2.5 ± 1.9 years. Upon risk stratification using FRAX scoring, in the high-risk cohort, fragility fractures occurred in 16.5% (n=22/133) of the CT group versus 13.5% (n=7/52) of the DH cohort (P=0.66). In the lower risk cohort based on FRAX scoring, fragility fractures occurred in 7.1% (n=10/131) of the CT group versus 6.0% (n=4/63) of the DH cohort (P=1.0). Conclusion: In our cohort, continued drug therapy did not provide additional fracture protective benefits beyond the minimum adequate duration of therapy. A drug holiday after three to five years of treatment may be considered after review of risk factors for future fracture.