ECTS2013 Oral Communications Treatment of osteoporosis (6 abstracts)
Effect of blosozumab on bone mineral density: results of a phase 2 study of postmenopausal women with low bone mineral density
Charles Benson 1 , Deborah Robins 1 , Robert Recker 2 , Jahangir Alam 1 , Alan Y Chiang 1 , Bruce Mitlak 1 , Adrien Sipos 1 & Leijun Hu 1
1Eli Lilly and Company, Indianapolis, Indiana, USA; 2Osteoporosis Research Center, Creighton University, Omaha, Nebraska, USA.
Introduction: Administration of antibodies that neutralize sclerostin has been demonstrated to increase bone mass. We report the key findings of a Phase 2 study of the human sclerostin antibody, blosozumab (bmab).
Methods: Study GSDB was a randomized, parallel-design, double-blind placebo-controlled study, designed to assess the dose–response relationship of bmab in postmenopausal women with low bone mineral density (BMD; lumbar spine (LS) T-score, −3.5 to −2.0). Participants were randomized to one of three subcutaneous (SC) bmab treatment regimens (180 mg every 2 weeks (Q2W); 180 mg every 4 weeks (Q4W), and 270 mg Q2W) or placebo for 52 weeks. In a study addendum, additional participants were randomized to bmab 270 mg SC every 12 weeks (Q12W) or placebo. Response was assessed as change from baseline in LS BMD, measured by dual energy X-ray absorptiometry (Table 1). Secondary objectives included evaluation of overall safety of bmab.
Results: Overall, 154 postmenopausal women were enrolled (mean baseline age 65 years, LS T-score −2.76). BMD findings are tabulated (P<0.001 bmab vs placebo in all cases). The frequency of adverse events was similar across treatment groups. Mild to moderate injection site reactions were more common with bmab.
| Least square mean percent change in LS BMD from baseline | |||||
| Placebo (n=37) | bmab 270 mg Q12W (n=26) | bmab 180 mg Q4W (n=31) | bmab 180 mg Q2W (n=30) | bmab 270 mg Q2W (n=30) | |
| 12 weeks | −0.92 | 5.02 | 3.73 | 6.18 | 7.14 |
| 24 weeks | −0.77 | 6.08 | 6.32 | 10.70 | 12.38 |
| 52 weeks | −1.52 | 6.72 | 8.39 | 14.86 | 17.75 |
Conclusion: Bmab treatment resulted in a significant increase in LS BMD at all time points and with all doses and was generally well tolerated. These data support its continued clinical study as a potential therapeutic agent for the treatment of osteoporosis in postmenopausal women.
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