EVENITY Side Effects: Clinical Trials vs Clinical Practice

EVENITY Side Effects: Clinical Trials vs. Clinical Practice

Comparing reported side effect rates from pivotal trials (FRAME & ARCH) with observations from a single clinical practice.

Clinical Trials (n = 5,000+)

McCormick (n = 211)

Joint & Musculoskeletal Pain

Trials

8–13%

Practice

~25%

Cardiac Effects

Trials

~2% MACE

Practice

~3.3%

Skin Reactions / Rash

Trials

Uncommon

Practice

~1.9%

A Note on Sample Size

Clinical observations from a single practice are valuable but carry wider statistical variability than large controlled trials. Differences in reported rates may reflect referral patterns, patient complexity, or how actively symptoms are assessed.

5,000+ Patients in clinical trials

211 Patients in clinical practice

Trial data: FRAME (n = 7,180) and ARCH (n = 4,093) studies. Cardiac "MACE" includes cardiovascular death, nonfatal MI, and nonfatal stroke. McCormick's cardiac observations include tachycardia and arrhythmias, which are not directly comparable to the MACE endpoint. Clinical practice data from Keith McCormick, DC, author of Great Bones.