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ACTIVE NOT RECRUITING

NCT06035458

Potential Osteocatabolic Effect Caused by Anti-CGRP mAbs in Migraine Patients Treated With Anti-CGRP mAbs - an Observational Pilot Project With Prospectively Collected Health Related Data

Sponsor: Ente Ospedaliero Cantonale, Bellinzona

View on ClinicalTrials.gov

Summary

Background: To gain insight on the osteoanabolic activity of anti-CGRP mAbs in patients with migraine as this was not yet specifically investigated in registration or post-approval clinical studies, however, being pathophysiologically plausible. If a clinically relevant, osteocatabolic effect caused by anti-CGRP mAbs will be demonstrated by the present investigation monitoring and mitigating strategies might be required and addressed in dedicated future studies. Objectives: To investigate whether treatment with anti-CGRP mAbs over 6, 12, and 24 months is associated with changes in bone density, structure and/or metabolic turnover in migraine patients. Project Design and Procedures: Prospective collection of health-related clinical data, open label, controlled pilot study. Demographic (ethnicity, age, sex) and physical (age, height) data, data on medical and migraine history will be collected. Clinical procedures include bone mineral measurement (bone densitometry, dxa) performed according to clinical practice; venipunctures for laboratory assessments (haematology and blood chemistry; bone turnover biomarkers P1NP and CTX).

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2022-04-13

Completion Date

2026-12-31

Last Updated

2025-07-28

Healthy Volunteers

Not specified

Conditions

Migraine Disorders

Interventions

DIAGNOSTIC_TEST

Diagnostic radiology

Clinical procedures include bone mineral measurement (bone densitometry, dxa) performed according to clinical practice; venipunctures for laboratory assessments (haematology and blood chemistry; bone turnover biomarkers P1NP and CTX).

Inclusion Criteria: Anti-CGRP mAbs treated group (TC): * Anti-CGRP mAbs naïve males and females; * Aged between 18 and 50 years; * Affected with migraine with or without aura \[4\]; * Planning to start a migraine preventive monotherapy with and satisfying the prescription criteria for Anti-CGRP mAbs erenumab, galcanezumab, and fremanezumab according to the Swiss reimbursement authorities (previous treatment with at least 2 migraine preventive therapies among beta-blockers, calcium antagonists, anticonvulsants and selective serotonin reuptake inhibitors SSRI must have been ineffective, contraindicated or not tolerated; mean number of monthly migraine days (MMD) in three consecutive months must be at least 8). Control group, not treated with anti-CGRP mAbs (CG) * Males and females * Aged between 18 and 50 years; * Affected with migraine with or without aura \[4\]; * Under no migraine preventive therapies; * Never treated with / not planning to start on anti-CGRP mAbs Exclusion Criteria: * An ongoing treatment with one of the following drugs: protonic pump inhibitors, selective serotonin reuptake inhibitors (such as escitalopram, fluoxetine, paroxetine, sertraline), glitazones, anti-aromatase, anti-androgen medications, glucocorticoids; having ever received glucocorticoids at doses of ≥5 mg (or equivalent) for ≥3 months, anti-retroviral drugs, vitamin k inhibitors or bone antiresorptive therapy; * An ongoing supplementation with calcium, vitamin D; * Being affected with osteoporosis or previous unprovoked fractures at adult age; * Being affected with significant comorbidities potentially interfering with bone metabolism including: type 1 or 2 diabetes; gastrointestinal malabsorption and/or chronic inflammatory bowel diseases; primary hyperparathyroidism; hyperthyroidism; prolonged immobilization; rheumatoid arthritis; chronic obstructive bronchopneumopathy; Cushing syndrome; any other relevant diseases according to the investigator's judgement; * A history of drug or alcohol abuse, or illicit substances use; * Hypogonadism; * Menopause; * Pregnancy or breastfeeding.

Locations (1)

Chiara ZECCA

Lugano, Canton Ticino, Switzerland