WCO-IOF 2016: Greater BMD increase after 1 year of romosozumab vesus teripratide

Study Type: Randomized Trial
OE Level of Evidence: N/A
Journal Level of Evidence: N/A
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Synopsis
436 postmenopausal women with osteoporosis who had been administered oral bisphosphonate therapy for 3 years prior were randomized in a phase 3 clinical trial to subcutaneous romosozumab or subcutaneous teriparatide. The purpose of this study was to compare the change in bone mineral density after 1 year of treatment between the two groups. Reported results demonstrated Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Amgen
Why was this study needed now?
New pharmacological interventions are continually being developed for osteoporosis management. One of the most recent developments is romosozumab, a sclerostin-targeting monoclonal antibody. Though preclinical and early clinical phase trials have pointed to good results, a phase III study was still needed. The study sought to evaluate the effect of romosozumab on bone mineral density in comparison to teriparatide among postmenopausal women with osteoporosis following a 3-year period of bisphosphonate therapy.
What was the principal research question?
In postmenopausal with osteoporosis who had previously been administered bisphosphonate therapy for 3 years, how did change in bone mineral density from baseline after 1 year compare between patients treated with romosozumab and patients treated with teriparatide?
Population: 436 postmenopausal women with osteoporosis (T-score > -2.5 at the femoral neck, total hip, or lumbar spine). Eligibility criteria also included women who had received oral bisphosphonate for the prior 3 years, and who had a history of nonvertebral fracture after 50 years of age or vertebral fracture.
Intervention: Romosozumab group: Patients were administered subcutaneous romosozumab 210mg monthly for 12 months
Comparison: Teriparatide group: Patients were administered subcutaneous teriparatide 20ug daily for 12 months
Outcomes: Outcomes included change from baseline in bone mineral density of the total hip, femoral neck, and lumbar spine on dual energy x-ray absorptiometry (DEXA). Quantitative computed tomography (qCT) was used to assess hip integral and cortical bone mineral density. Finite element analysis was used to estimate hip strength.
Methods: RCT; open trial
Time: Assessment at 6 and 12 months
What were the important findings?
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The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.