Investigating the effects of anti-CGRP medications on bone health in migraine patients

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

This study is testing whether anti-CGRP medications used for migraines affect bone health in people who take them compared to those who don’t.

Quick facts

• Study type: Observational
• Enrollment: 42 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Ente Ospedaliero Cantonale, Bellinzona (Academic / other)
• Drugs / interventions: erenumab, galcanezumab, fremanezumab, eptinezumab
• Locations: 1 site (Lugano, Ticino)
• Trial ID: NCT06035458 on ClinicalTrials.gov

What this trial studies

This observational pilot project aims to explore the potential osteocatabolic effects of anti-CGRP monoclonal antibodies (mAbs) in patients suffering from migraines. The study will collect health-related data over a period of 6, 12, and 24 months to assess changes in bone density, structure, and metabolic turnover among participants. It will include both a treatment group receiving anti-CGRP mAbs and a control group not receiving these medications, allowing for a comparative analysis of outcomes. The research is significant as it addresses a previously unexplored area regarding the long-term effects of migraine treatments on bone health.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 18 to 50 who are planning to start treatment with anti-CGRP mAbs and have a history of ineffective prior migraine preventive therapies.

Not a fit: Patients who are not planning to start anti-CGRP mAbs or those who have never been treated with these medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for migraine patients, particularly concerning their bone health.

How similar studies have performed: While this specific investigation is novel, other studies have shown the efficacy of anti-CGRP mAbs in treating migraines, but their effects on bone health remain largely untested.

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.

Where this trial is running

Lugano, Ticino

• Chiara ZECCA — Lugano, Ticino, Switzerland (Recruiting)

Study contacts

• Study coordinator: Chiara ZECCA, Prof, MD

Conditions Migraine Disorders; Migraine; anti-CGRP mAb; Densitometry; osteocatabolic effect