Teriparatide fracture effectiveness in the real world

Abstract

Dear Editors, After reading the description by Bonafede et al. [1] of the risk of fractures during teriparatide treatment using claims information, we wish to draw some additional inferences from the data.All patients contributed a year of data prior to teriparatide and 2 years of data after initiation of teriparatide; 52 % of the treated subjects were considered nonpersistent with teriparatide defined by a treatment gap of at least 90 days.During the year prior to teriparatide, 25.6 % of the patients had fracture claims. From the Kaplan-Meier analysis [1; see Fig. 2 therein], this approximate rate of fracture continued during the initial 90 days of teriparatide, but there was a reduced incidence of fracture thereafter, with the persistent patients having the lowest rate of fracture. Overall, the fracture incidence was 13.4 % during 2 years of follow up, a reduction versus the 25.6 % incidence in the 1 year prior to teriparatide. Comparisons of the fracture rate early during treatment to later during treatment in subsets defined by presence or absence of prior fracture, presence or absence of previous antiresorptive treatment, and presence or absence of persistence show effectiveness [1; see Fig. 3 therein].In the teriparatide placebo-controlled phase 3 fracture trial, teriparatide reduced the incidence of nonvertebral low-trauma fractures by 53 % after a median exposure of 19 months [2].The nonvertebral fracture reduction increased with longer treatment duration [3]. 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.We interpret the real-world work of Bonafede et al. to contribute nicely to the body of literature demonstrating effectiveness of teriparatide to reduce fractures, that the anabolic effect of teriparatide to reduce fractures becomes evident after a few months, that the fracture reduction is not complete in such a high-risk population, that there appears to be effectiveness in a variety of subsets, and that persistent patients have the lowest fracture incidence.

Teriparatide for osteoporosis: importance of the full course

“…Using the same database, another group reported teriparatide outcomes for 11,407 patients similarly treated with teriparatide and having similar pre- and post-treatment follow-up [ 77 ]. This study appeared to show similar results and confirmed lower risk for fracture for persistent versus non-persistent patients [ 78 ].…”

Fracture Rate, Quality of Life and Back Pain in Patients with Osteoporosis Treated with Teriparatide: 24-Month Results from the Extended Forsteo Observational Study (ExFOS)

“…Analyses of claims databases have shown an inverse relationship between persistence with teriparatide therapy over 24 months and fracture risk [ 25 , 26 ]. Nevertheless, treatment effectively reduces fractures after only a few months and, thereafter, persistent patients show the lowest fracture incidence [ 26 , 27 ].…”

Hip and other fragility fracture incidence in real-world teriparatide-treated patients in the United States

“…Fractures that occurred after 90 days from the index date were considered incident fractures to provide sufficient time for therapeutic effects from teriparatide to begin. The 90-day interval for onset of teriparatide effect is supported by work from Bonafede et al using the same claims database [34]; during the year prior to teriparatide, 25.6% of the patients had fragility fracture claims and this approximate rate of fracture continued during the initial 90 days of teriparatide, but was lower thereafter [34, 35]. Hip fractures were identified by fracture diagnoses from inpatient admission claims.…”

“…Previous research on teriparatide adherence and persistence supports the hypothesis that longer duration and higher rates of adherence are associated with improved patient outcomes [20–23, 32–35]. Moreover, retrospective claims database studies have reported lower nonvertebral fracture incidence with longer exposures [23, 33, 34].…”