Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Ente Ospedaliero Cantonale, Bellinzona
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-50 years
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, h...
Detailed Description
Migraine is a chronic and often lifelong disease defined by recurrent unprovoked headache episodes lasting over four hours with one or more disabling symptoms including nausea, vomiting, dizziness, an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06035458
Start Date
April 13 2022
End Date
December 31 2026
Last Update
July 28 2025
Active Locations (1)
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1
Chiara ZECCA
Lugano, Canton Ticino, Switzerland, 6903