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Results from a randomized, open-label, active comparator, phase 3 controlled study demonstrate that a recombinant human parathyroid hormone analog significantly increased lumbar spine volumetric bone mineral density compared with a bisphosphonate in men with glucocorticoid-induced osteoporosis.
According to the literature, teriparatide (Forteo, Eli Lilly and Company) is administered in a multi-dose prefilled delivery pen containing 28 daily doses of 20 mcg.
For this study, an 18-month open-label, randomized controlled trial was conducted in four European countries. The trial included men who had taken glucocorticoids for more than 3 months and had an areal BMD T-score of less than –1.5 (standard deviation), according to researchers. They were randomly assigned teriparatide 20 mcg per day (n=45) or risedronate 35 mg per week (n=47) and 1 g calcium and 1,200 IU vitamin D daily.
Data indicate that teriparatide and risedronate significantly increased lumbar spine volumetric BMD, with greater increases observed in patients assigned to teriparatide (mean change from baseline: 16.3% vs. 3.8%; P=.004) at 18 months.
“Though we often think of osteoporosis as a women’s disease, men can get it too. In fact, approximately 2 million American men have osteoporosis,” Claus-C. Glüer, PhD, professor of medical physics in the department of diagnostic radiology at the University Medical Center Schleswig-Holstein in Germany, said in a press release. “These study results can help health care professionals better determine which treatment may be best suited for individual male patients with glucocorticoid-induced osteoporosis.”
Of the secondary outcome data, Glüer and colleagues reported statistically significant increases in estimated vertebral strength in both groups (teriparatide: 26% to 34% vs. risedronate: 4.2% to 6.7%; P<.005) after 18 months.
Moreover, they wrote that adverse events were similar between groups, with five patients (10.6%) developing new fractures in the risedronate group, whereas zero displayed new fractures in the teriparatide group.
Disclosure: Glüer has received honoraria and research support from Eli Lilly & Company. See the study for a full list of disclosures.
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