Phase III ATOM trial of Tymlos shows positive results in osteoporosis.
The ATOM study met its primary endpoint – the percentage change in lumbar spine (LS) bone mineral density (BMD) compared to placebo – demonstrating statistical significance after 12 months (p-value < 0.0001).
Study participants receiving abaloparatide-SC experienced an average increase in LS BMD of 8.5% compared to patients receiving the placebo experiencing an average increase of 1.2%. The study also met secondary endpoints, which measured the percentage change compared to placebo for lumbar spine BMD at 6 months, total hip BMD at 12 months, and femoral neck BMD at 12 months. The safety profile of abaloparatide in the ATOM study was consistent with results in previously reported trials. The Company will complete a full evaluation of the ATOM data and work with investigators to present detailed results at a future medical meeting.
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