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

Launched by ENTE OSPEDALIERO CANTONALE, BELLINZONA · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the potential effects of a type of migraine treatment called anti-CGRP monoclonal antibodies (mAbs) on bone health. Researchers want to find out if these medications, which are used to prevent migraines, could affect bone density and overall bone health in patients over time. The study will collect health-related information from participants over 6, 12, and 24 months to see if there are any changes in their bone structure or metabolism while they are receiving this treatment.

To participate in this trial, individuals must be between 18 and 50 years old and diagnosed with migraines. They can either be starting treatment with anti-CGRP mAbs or not planning to use them at all. The study will not include people who are currently taking certain other medications or have specific health conditions that could affect bone health. Participants can expect to undergo some health assessments, including tests to measure bone density and blood tests, while they help researchers learn more about the safety of these migraine treatments for bone health.

Gender

ALL

Eligibility criteria

• 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.