Full Length ArticleReal-world effectiveness of teriparatide on fracture reduction in patients with osteoporosis and comorbidities or risk factors for fractures: Integrated analysis of 4 prospective observational studies
Introduction
Teriparatide [recombinant human parathyroid hormone (1–34)] stimulates bone formation and is approved worldwide for the treatment of men and postmenopausal women with osteoporosis at high risk for fracture and in some geographies for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
Teriparatide reduced osteoporotic fracture risk in clinical trials compared with placebo [1] or oral bisphosphonates [[2], [3], [4]], and in observational studies [[5], [6], [7], [8]]. While randomized, controlled trials remain the gold standard in establishing the efficacy of therapies in defined populations, they also exclude many patients, including prior or concomitant therapies, and include visit structures, interactions, information collection, and other factors that may differ substantially from common clinical practice [9]. Thus, observational studies may be useful to assess the effectiveness of drugs in the setting of community care of patients having particular comorbid conditions, risk factors, or prior therapies.
The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) [7], European Forsteo Observational Study (EFOS) [5], Extended Forsteo Observational Study (ExFOS) [6], and Japan Fracture Observational Study (JFOS) [8] were prospective, observational studies conducted at a large numbers of sites in the United States, Europe, and Japan, respectively. Each assessed fracture rates during up to either 18 to 24 months of teriparatide therapy in patients selected according to normal clinical practice and the local approved label. In a separate report, we have presented detailed analysis of fracture rates for clinical vertebral fracture (CVF), nonvertebral fracture (NVF), clinical fracture, hip fracture, and wrist fracture in the combined study population (submitted). In the present report, we used the combined database to examine rates of CVF, NVF, and clinical fractures during teriparatide treatment in clinically relevant subgroups.
Section snippets
Study designs and populations
DANCE, EFOS, ExFOS, and JFOS were multicenter, prospective, observational studies to examine the long-term effectiveness, safety, and tolerability of teriparatide in a community-based population of men and women (or women only, in EFOS). These studies were conducted in the USA, Japan and 12 European countries (Supplemental Table 1), and the results have been reported previously for each study [[5], [6], [7], [8]]. Patients were enrolled based on the local product labeling and investigators'
Patient characteristics
These analyses included data from 8828 patients, including 3720 from DANCE, 1581 from EFOS, 1531 from ExFOS, and 1996 from JFOS. Patient demographics and risk factors in these studies have been reported previously [[5], [6], [7],12]. In this pooled population from the 4 studies, 92% of patients were female (only women participated in EFOS) and mean age was 71 years (Table 1). Mean (standard deviation) teriparatide treatment duration was 17.4 (8.6) months.
Fracture rates
A summary of rates for CVF, NVF,
Discussion
In this report, we assessed pooled data for 8828 patients from 4 prospective observational studies conducted in Europe, the United States, and Japan [[5], [6], [7], [8]], comparing rates of fracture between the first 6 months of teriparatide treatment to the rate of fracture for the remaining treatment period of up to 24 months. The analyses also provided information on the clinical risk factors that could influence the effects of teriparatide in reducing fractures during real-world treatment.
Disclosures
B.L.L. has received fees for serving on advisory boards, speaking at symposia, and has received research grants from Eli Lilly and Co. Amgen, UCB, Merck, Novo Nordisk; S.·Silverman is on the Speaker's Bureau and is a consultant for and has received research support from Eli Lilly and Company; K.S. has received consultant fees and has research grants from Eli Lilly and Company; N.N. has received consultant and speaker fees from Eli Lilly and Company; S.F. and S.·Soen have nothing to declare;
Funding
This work was funded by Eli Lilly and Company or one of its affiliates.
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