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

NCT06035458 | Active Not Recruiting

• 1 other identifier: EOCNSIHA_2201
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Migraine Disorders

Keywords

Migraine; anti-CGRP mAb; Densitometry; osteocatabolic effect

Outcome Measures

Primary Outcomes (1)

• Changes in bone mineral density

  Change in lumbar spine, total hip and femoral neck bone mineral density and lumbar spine TBS during anti-CGRP mAb.

  6-12 months

Interventions

Diagnostic radiology DIAGNOSTIC_TEST

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).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present with migraine at the Headache out-patient clinic, Neurocenter of Southern Switzerland, EOC, will be recruited during routine clinical evaluations. At our Headache Clinic, migraine patients planned to start an anti-CGRP mAb undergo a preliminary screening to identify those suffering from or at increased risk of osteoporosis/osteopenia. Patients not planned to start an anti-CGRP mAb will be screened to match a treated patient for age and sex.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Chiara ZECCA

Lugano, Canton Ticino, 6903, Switzerland

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: April 13, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)