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
This ACE Report is a summary of a conference presentation or abstract. The information provided has limited the ability to provide an accurate assessment of the risk of bias or the overall quality. Please interpret the results with caution as trials may be in progress and select results may have been presented.
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?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.