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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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Mar 31, 2025 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  2. Study Identification, Study Status, Oversight, Eligibilityv4
  3. Primary and study completion dates: Mar 31, 2024 to Mar 31, 2025v3
  4. Study description shortened, about 17 wordsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06035458
Lead Sponsor Ente Ospedaliero Cantonale, Bellinzona
Conditions
(from sponsor)		 Migraine Disorders
Related terms Migraine Disorders
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov