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Oral teriparatide tablet (EB613) gets FDA nod for Phase 3 trial

Osteoporosis & Bone Health | Last Active: Jun 30 2:13pm | Replies (28)
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@mayblin Do you know if that would involve the full dose and normal length of treatment for both?

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Replies to "@mayblin Do you know if that would involve the full dose and normal length of treatment..."
mayblin | @mayblin | Jun 25 9:12am

@tillymack
For Combined Anabolic Therapy (CAT) Phase 4 trial, fulll dose of romosoumab (210mg) and teriparatide (20mcg) will be used. Study duration: 12mo. 2 study groups: romosoumab vs romosozumab + teriparatide. Outcome measure will be L-spine Lumbar areal bone mineral density 12mo vs 0mo.

For oral teriparatide tablet (EB613), the chosen dosage hasn't been disclosed. Duration of the study will be 12mo, with "an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data"; and "primary endpoint of total hip bone mineral density (BMD) at Month 12".

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