NCT06035458Active, 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
Source: ClinicalTrials.gov · Last updated 28 Jul 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 42 (estimated)
- First submitted
- 6 Sept 2023
- Start date
- 13 Apr 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Diseases
- Migraine
- NCT number
- NCT06035458
What you commit to
- Study type: Observational
- Planned participants: 42
- From 13 Apr 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chiara ZECCA Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.