Two Years of Teriparatide Significantly Decreases Risk of New Fractures in Women With Severe Osteoporosis

[Presentation title: Teriparatide Compared With Risedronate and the Risk of Clinical Vertebral Fractures: 2-Year Results of a Randomised, Double-Dummy Clinical Trial. Abstract 320]

 Two years of teriparatide significantly decreases the risk of a new clinical vertebral fracture in postmenopausal women with severe osteoporosis, compared with risedronate, according to a study presented here at the 2017 Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).

“Our data inform clinicians of the superior anti-fracture efficacy of teriparatide in the management of severe osteoporosis,” said Cristiano A.F Zerbini, MD, Centro Paulista de Investigações Clinicas, São Paulo, Brazil.

Currently approved treatments for osteoporosis include antiresorptive and anabolic medications. While prior studies have compared the effects of these 2 different classes of drugs on surrogate markers of bone strength and quality, no head-to-head studies have compared the effects of antiresorptives and anabolic drugs on reducing the risk of fractures as the primary outcome.

Investigators at multiple sites worldwide determined clinical vertebral fracture incidence over 2 years in 1,360 ambulatory postmenopausal women who were randomised to subcutaneous teriparatide 20 µg/day or oral risedronate 35 mg/week as part of the Vertebral Fracture Treatment Comparisons in Osteoporotic Women (VERO) study. Active treatment was preceded by a screening phase lasting up to 4 weeks

Study participants had at least 2 moderate (ie. a reduction in vertebral body height of 26% to 40%) or 1 severe (more than 40% reduction) prevalent vertebral fragility fracture. They also had low bone mass, defined as bone mineral density T-score ≤-1.5 standard deviations at the lumbar spine, total hip, or femoral neck.

The 24-month incidence of new radiographic vertebral fractures was 5.4% (28 of 516 patients) in the teriparatide group versus 12.0% (64 of 533) of patients in the risedronate group (P < .001), for an absolute risk reduction of 6.6%.

A total of 31 women were diagnosed with an incident clinical vertebral fracture over the 24-month study duration: 7 women in the teriparatide group (1.1%) and 24 women (3.9%) in the risedronate group (hazard ratio [HR] = 0.29; P = .002).

The incidence rates expressed as the number of fractures per 100 patient-years were 0.58 and 1.97 in teriparatide- and risedronate-treated patients, respectively (P = .004).

The HR with the estimated Cox model including the time-dependent treatment-by-time interaction reached statistical significance at 12 months of follow-up (HR at 12 months = 0.27; P = .011).

Dr. Zerbini said that VERO is the largest trial of 2-years duration with the approved dose of teriparatide in postmenopausal women with osteoporosis. Importantly, the study included a large population of patients previously treated with antiresorptive drugs, mainly bisphosphonates, reflecting current clinical practice, he added.

Funding for this study was provided by Eli Lilly and Company.

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