Teriparatide reduces risk of fractures in osteoporotic patients
Teriparatide appears to produce significant reductions in the incidence of fractures in the period beyond 6 months after treatment initiation, with the benefit consistently observed across important patient subgroups, according to data from four real-world studies.
These real-world treatment data suggest that the anabolic agent is effective in patients with a range of pre-existing conditions, the investigators said.
The analysis included 8,828 osteoporosis patients (mean age 71 years; 92 percent female) from the following cohort studies: DANCE (Direct Assessment of Nonvertebral Fractures in Community Experience), EFOS (European Forsteo Observational Study), ExFOS (European Extended Forsteo Observational Study) and JFOS (Japan Fracture Observational Study). All patients received teriparatide at 20 μg/day for up to 24 months (mean treatment duration, 17.4 months).
Based on pooled data, fracture incidence markedly declined during >6 months vs 0–6 months of treatment initiation. Specifically, rates of clinical vertebral fracture (CVF) decreased by 62 percent, nonvertebral fracture (NVF) by 43 percent, clinical fracture by 50 percent and hip fracture by 56 percent (p<0.005 for all). [Bone 2018;doi:10.1016/j.bone.2018.07.013]
The significantly lower fracture rates observed in the >6-month period were consistent in all subgroups (age, gender, diabetes status, prior bisphosphonate use, rheumatoid arthritis [RA] comorbidity, prior vertebral fracture), with the exception of CVF in elderly patients (patients aged <75 years responded better; p=0.074) and clinical fractures in nondiabetic patients (patients with diabetes responded better; p=0.046). Nevertheless, all subgroups had significant reductions in fracture rates over time.
Factors such as glucocorticoids, prior bisphosphonate and prior vertebral fracture were associated with greater CVF, NVF and clinical fracture rates. Meanwhile, RA, prior hip fracture and female gender were associated with higher NVF and clinical fracture rates. Finally, older age was linked to increased CVF and clinical fracture rates.
“The ability to assess fracture rates in subgroups of patients receiving teriparatide during real-world treatment is a major strength of these analyses, particularly for conditions such as RA and diabetes mellitus and for glucocorticoid use, where fracture risk appears to be elevated independent of bone mineral density,” the investigators said.
Additionally, the information on the fracture reduction observed after bisphosphonate use is clinically relevant, given that many patients receive teriparatide as second-line treatment after inadequate responses to bisphosphonates, they added.
Despite the analysis’ strengths, the investigators stressed that the findings should be interpreted while keeping several limitations in mind. For the most part, the four studies lacked a control group. As these studies are observational in nature, data are not monitored as closely as those in randomized trials. Furthermore, incident NVF and CVF events were assessed locally by the investigative site without central adjudication.