Characterizing Women With Osteoporosis Initiating Treatment in a Real-World Setting

Abaloparatide and teriparatide are the only anabolic agents approved by the FDA for women with osteoporosis at high-risk of fragility fractures.

The poster titled, “Characterizing patients initiating abaloparatide, teriparatide or denosumab in a real-world setting: a US linked claims and EMR database analysis” by Erik Imel et al, was presented by Setareh Williams at the American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition conference on December 3, 2018.

The objective of the study was to identify and characterize patients initiating treatment with abaloparatide (ABL), teriparatide (TPTD), or denosumab (DMAB) in a real-world setting. Abaloparatide (ABL) is a parathyroid hormone- (PTH) related peptide analog that increases bone mineral density (BMD) and reduces fracture risk in post-menopausal women with osteoporosis (PMO). ABL and TPTD are the only anabolic agents approved by the FDA for women with PMO at high-risk of fragility fractures.

Patients ≥18 years of age at index date and ≥1 prescription or fill of ABL, TPTD, or DMAB were included. The index date was defined as the date of the initial prescription or fill for between May 2017 and September 2018 (the identification period).

Overall, 2666 ABL patients, 9210 TPTD patients, and 116,718 DMAB patients were new to therapy and the median duration of pre-index historical data per patient was 4.59 years. Mean age was 72 years overall and 91% of patients were female.

The most prevalent comorbid conditions included osteoarthritis (49%), gastrointestinal disorders (47%), type 2 diabetes (21%), and respiratory diseases (chronic obstructive pulmonary disease [COPD]: 20% and asthma: 13%). Both ABL- and TPTD-treated patients had lower mean comorbidity scores as assessed by the Charlson Comorbidity Index compared with DMAB-treated patients, with 36%, 39%, and 48% of ABL, TPTD, and DMAB patients, respectively, having a score of ≥2 (P<0.001). Approximately 58% of all patients had one or more conditions associated with increased fall risk.

The mean duration from first PMO diagnosis to the initiation of treatment was 3.0 years. Proportion of patients with BMD by DEXA in the 12 months prior to the index date were higher for patients initiating DMAB (26%) versus those initiating ABL (21%) or TPTD (19%). Overall, 10% of patients had a history of any pathological or fragility fracture (19% ABL, 19% TPTD, and 10% DMAB) and 7% had a pathologic fracture in the year prior to index treatment initiation (16% ABL, 15% TPTD, and 7% DMAB).

Overall, 17%, 2%, and 20% of patients had prior exposure to bisphosphonate(s), selective estrogen receptor modulators, or other osteoporosis medications, respectively. Forty-seven percent of all patients had prior exposure to glucocorticoids (53%, 54%, 47% for ABL-, TPTD-, and DMAB-treated patients respectively; P<0.001). Nineteen percent were currently on glucocorticoids (17%, 26%, and 19% for ABL-, TPTD-, and DMAB-treated patients respectively; P<0.001). In conclusion, patients initiating ABL, TPTD, and DMAB showed some differences in clinical and demographic characteristics and comorbidities prior to treatment initiation.