Related Experiment Video
Updated: Jun 18, 2026
Detection and Quantification of Calcitonin Gene-Related Peptide (CGRP) in Human Plasma Using a Modified Enzyme-Linked Immunosorbent Assay
Published on: June 16, 2023
Anti-CGRP monoclonal antibody therapy for migraine is not associated with early adverse bone effects: a prospective,
Giulia Mallucci1, Chiara Camponovo2,3, Alberto Cordella1
1Neurocenter of Southern Switzerland, EOC, Lugano, Switzerland.
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 detected for BMD, CTX or P1NP (all p > 0.05). Lumbar spine TBS showed a small between-group difference in change over time (group×time interaction), with a greater decrease in treated patients than in controls (β = -0.052, 95% CI - 0.095 to -0.008; p = 0.023), with values remaining within the normal range. Anti-CGRP treatment was clinically effective, with ≥50% and ≥75% reductions in monthly migraine days achieved by 80.8 and 42.3% of patients, respectively.
Discussion:
This prospective, observational, controlled, cohort study suggests that anti-CGRP mAb therapy is not associated with early adverse effects on bone density, structure, or turnover, while providing substantial migraine improvement. Ongoing follow-up will determine longer-term skeletal safety.
Clinical Trial Registration:
ClinicalTrials.gov, NCT06035458.
