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
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ClinicalTrials.gov Identifier: NCT06035458 |
Recruitment Status :
Recruiting
First Posted : September 13, 2023
Last Update Posted : October 10, 2023
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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).
Condition or disease | Intervention/treatment |
---|---|
Migraine Disorders | Diagnostic Test: Diagnostic radiology |
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Study Type : | Observational |
Estimated Enrollment : | 42 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | April 13, 2022 |
Estimated Primary Completion Date : | March 31, 2024 |
Estimated Study Completion Date : | March 31, 2024 |
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- Diagnostic Test: Diagnostic radiology
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).
- Changes in bone mineral density [ Time Frame: 6-12 months ]Change in lumbar spine, total hip and femoral neck bone mineral density and lumbar spine TBS during anti-CGRP mAb.
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
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.
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:
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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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035458
Contact: Chiara ZECCA, Prof, MD | +41918116688 | chiara.zecca@eoc.ch | |
Contact: Rosaria Sacco, MD, PhD | +41918116688 | rosaria.sacco@eoc.ch |
Switzerland | |
Chiara ZECCA | Recruiting |
Lugano, Ticino, Switzerland, 6903 | |
Contact: Chiara ZECCA, Prof, MD +41918116688 chiara.zecca@eoc.ch | |
Contact: Rosaria Sacco, MD, PhD +41918116688 rosaria.sacco@eoc.ch |
Responsible Party: | Chiara Zecca, Prof, Ente Ospedaliero Cantonale, Bellinzona |
ClinicalTrials.gov Identifier: | NCT06035458 |
Other Study ID Numbers: |
EOCNSIHA_2201 |
First Posted: | September 13, 2023 Key Record Dates |
Last Update Posted: | October 10, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Migraine anti-CGRP mAb Densitometry osteocatabolic effect |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |