Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study

Abstract

ObjectivesTo describe fracture rates, back pain, and health-related quality of life (HRQoL) in postmenopausal women with osteoporosis and prior bisphosphonate therapy, treated with teriparatide for up to 18 months and followed up for a further 18 months.DesignProspective, multinational, and observational study.MethodsData on prior bisphosphonate use, clinical fractures, back pain visual analog scale (VAS), and HRQoL (EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month intervals and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed using a repeated measures model.ResultsOf the 1581 enrolled patients with follow-up data, 1161 (73.4%) had a history of prior bisphosphonate use (median duration: 36 months). Of them, 169 (14.6%) sustained ≥1 fracture during 36-month follow-up. Adjusted odds of fracture were significantly decreased at each 6-month interval compared with the first 6 months of teriparatide treatment: 37% decrease in the 12 to <18 months period during teriparatide treatment (P=0.03) and a 76% decrease in the 12- to 18-month period after teriparatide was discontinued (P<0.001). Significant reductions in back pain and improvement in HRQoL were observed.ConclusionsPostmenopausal women with severe osteoporosis previously treated with bisphosphonates had a significant reduction in the incidence of fractures compared with the first 6 months of therapy, a reduction in back pain and an improvement in HRQoL during up to 18 months of teriparatide treatment. These outcomes were still evident for at least 18 months after teriparatide was discontinued. The results should be interpreted in the context of an uncontrolled, observational study in a routine clinical setting.

Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)

“…In clinical practice, teriparatide is commonly used as a second-line treatment for osteoporosis, usually after a bisphosphonate. The EFOS study showed a reduction in clinical fractures during teriparatide treatment among patients who had previously taken bisphosphonates (almost three-fourths of the study cohort) 21 . However, observational studies on teriparatide treatment for 24 months in patients with the newly approved indications are needed.…”

Parathyroid Hormone and Parathyroid Hormone-Related Protein Analogs as Therapies for Osteoporosis

“…The odds of vertebral and non-vertebral fragility fractures progressively decreased during this period; compared to the first six months of teriparatide treatment, there was a 37% decrease in the adjusted odds of fracture during the final six months of teriparatide treatment. Even after teriparatide treatment was discontinued, odds of fracture were 76% lower than during the first 6 months of treatment, although many of the patients resumed use of an antiresorptive drug after completing the course of teriparatide [45]. Thus, use of teriparatide can reduce fracture risk despite prior bisphosphonate treatment, though the response to teriparatide may be delayed.…”

Teriparatide relieves ovariectomy-induced hyperalgesia in rats, suggesting the involvement of functional regulation in primary sensory neurons by PTH-mediated signaling

“…In this study, we applied 2 pain-related behavioral tests-the plantar test (paw flick test, a test observing avoidance of heat stimulation) and the von Frey test (a test to evaluate hyperalgesia by observing avoidance of mechanical stimulation)-to OVX rats to experimentally evaluate whether or not TPTD exerts an antinociceptive effect on this osteoporotic animal model, as has been observed in several clinical reports [15][16][17][18][19][20][21][22][23][24][25] . The plantar test showed that the withdrawal latency was gradually reduced in the OVX rats during the observation period compared with the Sham-vehicle group, confirming thermal hyperalgesia caused by OVX 8,10,11 .…”