Скачать с ютуб Update from Dr. Alison Skrinar on the Ultragenyx trials, Orbit and Cosmic. в хорошем качестве

Update from Dr. Alison Skrinar on the Ultragenyx trials, Orbit and Cosmic.

The OI Foundation recently shared an announcement from Ultragenyx which shared Interim data from the Phase 2 portion of their Orbit study. This data showed that treatment with setrusumab reduced incidence of fractures in patients with OI by 67% following at least 6 months of treatment and demonstrated improvements in lumbar spine bone mineral density (BMD). Click here to view the full press release. Ultragenyx is now enrolling participants for the Phase III of this trial. The trials are open to children with Types I, III, and IV OI and have sites around the country. In this recording, Dr. Alison Skrinar (Ultragenyx) joined OIF Board Member Dr. Michelle Fynan to discuss setrusumab and the clinical trial process. To learn more about Ultragenyx research, visit https://www.ultraclinicaltrials.com/OI or reach out via email, [email protected]. --- Timestamps ---- 00:00 Welcome 05:50 Clinical trial phases 08:59 More about the two trials 13:20 How setrusumab differs from bisphosphonates 15:11 Why study participants must not be receiving bisphosphonates during the ORBIT study. 16:52 Why we aren't looking at the many different types of OI 19:17 The "Extension Period" Explained 24:55 Who is the ideal candidate? 28:21 Any adverse effects? 29:15 What if a participants situation changes? 30:45 Revisiting the clinical trial phases 34:35 Conclusion