Anti-CGRP monoclonal antibody therapy for migraine is not associated with early adverse bone effects: a prospective, observational, controlled, cohort study
Abstract
Background and objective Calcitonin gene–related peptide (CGRP) is a key mediator in migraine and a target of recent preventive therapies. Since CGRP is also expressed in bone and involved in skeletal regulation, concerns have been raised regarding potential bone effects of CGRP pathway inhibition. We report a prespecified 6-month analysis of a prospective, observational controlled, cohort study evaluating early bone outcomes during anti-CGRP monoclonal antibody (mAb) therapy. Methods Adults with migraine initiating anti-CGRP mAb monotherapy (treated, n = 27) and age- and sex-matched migraine controls not receiving preventive therapy (controls, n = 14) underwent dual-energy X-ray absorptiometry [bone mineral density (BMD) at lumbar spine, total hip, and femoral neck], lumbar trabecular bone score (TBS), and bone turnover marker assessment (serum CTX and P1NP) at baseline and 6 months. The primary endpoint was the within-treated change from baseline to month 6 in BDM and TBS. Secondary endpoint included within-patient changes in bone turnover markers and between-group change from baseline to month 6, which were assessed using linear mixed-effects models. Results At baseline, BMD, TBS, CTX and P1NP were within the expected age-specific range in both groups. After 6 months of anti-CGRP mAb exposure all values remained within normal ranges and no clinically meaningful changes in BMD, TBS, CTX or P1NP were observed. In adjusted models, no significant group×time interactions were…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 27 participants or records.
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