Abstract
SummaryStudies examining real-world effectiveness of osteoporosis therapies are beset by limitations due to confounding by indication. By evaluating longitudinal changes in fracture incidence, we demonstrated that osteoporosis therapies are effective in reducing fracture risk in real-world practice settings.IntroductionOsteoporosis therapies have been shown to reduce incidence of vertebral and non-vertebral fractures in placebo-controlled randomized clinical trials. However, information on the real-world effectiveness of these therapies is limited.MethodsWe examined fracture risk reduction in older, post-menopausal women treated with osteoporosis therapies. Using Medicare claims, we identified 1,278,296 women age ≥ 65 years treated with zoledronic acid, oral bisphosphonates, denosumab, teriparatide, or raloxifene. Fracture incidence rates before and after treatment initiation were described to understand patients’ fracture risk profile, and fracture reduction effectiveness of each therapy was evaluated as a longitudinal change in incidence rates.ResultsFracture incidence rates increased during the period leading up to treatment initiation and were highest in the 3-month period most proximal to treatment initiation. Fracture incidence rates following treatment initiation were significantly lower than before treatment initiation. Compared with the 12-month pre-index period, there were reductions in clinical vertebral fractures for denosumab (45%; 95% confidence interval [CI] 39–51%), zoledronic acid (50%; 95% CI 47–52%), oral bisphosphonates (24%; 95% CI 22–26%), and teriparatide (72%; 95% CI 69–75%) during the subsequent 12 months. Relative to the first 3 months after initiation, clinical vertebral fractures were reduced for denosumab (51%; 95% CI 42–59%), zoledronic acid (25%; 95% CI 17–32%), oral bisphosphonates (23%; 95% CI 20–26%), and teriparatide (64%; 95% CI 58–69%) during the subsequent 12 months.ConclusionIn summary, reductions in fracture incidence over time were observed in cohorts of patients treated with osteoporosis therapies.
Highlights
Osteoporosis is a disease characterized by compromised bone strength and increased risk of fractures
After application of the inclusion and exclusion criteria, 34,622 denosumab, 124,857 zoledronic acid, 997,686 oral bisphosphonate, 100,521 raloxifene, and 20,610 teriparatide patients were included in the study cohort (Fig. 1)
Fracture incidence rates were highest for teriparatide and lowest for raloxifene during each of the four 3-month intervals in the pre-index period
Summary
Inherent differences in pre-treatment risk profiles in treated patients pose a serious challenge when evaluating treatment effectiveness in real-world settings. We compared fracture incidence during the first 3 months on treatment with that in the subsequent 12-month period This approach has been previously employed to assess fracture risk reduction in patients treated with bisphosphonates [13]. For the second approach, change in fracture incidence was estimated between the first 3 months on treatment (early period) and the subsequent 12-month on-treatment period For both approaches, patients were at risk for fracture outcomes from the index date until occurrence of a censoring event during the on-treatment period (death, discontinuation of Medicare enrolment, switching from index medication to a different study medication or calcitonin, diagnosis of cancer [excluding non-melanoma skin cancer] or Paget’s disease, chemotherapy or radiation therapy for cancer treatment). Stratified analysis was conducted for those with and without a history of osteoporosis medication use or prior fracture [16, 17]
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