ECTS2013 Oral Communications Treatment of osteoporosis (6 abstracts)
Bone anabolic efficacy and safety of ba058, a novel analog of hPTHrP: 12-month extension data from a phase 2 clinical trial in postmenopausal women with osteoporosis
Gary Hattersley 1 , John Bilezikian 2 , Jonathan Guerriero 1 , Prasanna Kumar 3 , Jose Zanchetta 4 , C Richard Lyttle 1 & Louis Saint L O’Dea 1
1Radius, Cambridge, Massachusetts, USA; 2Columbia University College of Physicians and Surgeons, New York, New York, USA; 3M S Ramaiah Memorial Hospital, Bangalore, India; 4Instituto de Investigaciones Metabolicas, Buenos Aires, Argentina.
A randomized, placebo-controlled phase 2 study evaluated the safety and efficacy of BA058, an analog of hPTHrP(1–34), in postmenopausal women with severe osteoporosis. 221 patients were randomized to received BA058 20, 40, and 80 μg, placebo or teriparatide (TP) 20 μg, by daily s.c. injection. 184 (83%) patients completed an initial 24 weeks of treatment. The mean percent change in lumbar spine BMD at 24 weeks was 1.6% with placebo, 6.7% with BA058 80 μg, and 5.5% with TP. A marked increase in total hip BMD was also seen, where the change was 0.4% with placebo, 2.6% with BA058 80 μg, and 0.5% with TP. 55 of the 69 eligible patients received an additional 24 weeks of treatment. Lumbar spine BMD continued to increase, with a change at 48 weeks of 0.7% with placebo, 12.9% with BA058 80 μg, and 8.6% with TP. Gains in hip BMD were also seen, with a mean change for the total hip 0.7% with placebo, 2.7% with BA058 80 μg, and 1.3% with TP, and at the femoral neck 1.0% with placebo, 4.1% with BA058 80 μg, and 2.2% with TP. BA058 was generally well tolerated with treatment-related TEAEs reported in 66 (30%) of 221 patients during the initial 24 weeks of treatment and 16 (29%) of 55 patients during the extension, with similar proportions across treatment groups. Nine patients (4%) discontinued due to an adverse event, seven during the initial 24 weeks and two during the extension. SAEs were reported in four patients, none were treatment related. In conclusion, treatment with BA058 80 μg resulted in marked spine and hip BMD gains over 48 weeks. BA058 was well tolerated, with safety events comparable to placebo. The safety and efficacy data supported advancement of BA058 80 μg into an ongoing phase 3 fracture prevention study.
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