CGRP Migraine

C
Christopher T. Jackman, MD

Primary Investigator

Administratively Closed
13 years - 100 years
All
Phase N/A
40 participants needed
1 Location

Brief description of study

The overall objective is to prospectively evaluate bone and muscle outcomes in a 12-month longitudinal observational cohort of adults and children with migraine receiving CGRP monoclonal antibody therapy.

Detailed description of study

Our hypothesis is that CGRP targeted migraine drugs will: a) decrease volumetric BMD and estimated failure load as measured by high resolution peripheral quantitative computed tomography (HRpQCT) at the distal radius and tibia; b) decrease areal BMD measured by dual energy X-ray absorptiometry (DXA) at the lumbar spine, total body, femur neck, and total hip; and c) decrease bone formation markers and increase bone resorption markers.CGRP(-R) antibody treatment: This is an observational study, and the protocol will not direct therapy. Decisions regarding medical therapy will be determined entirely by the subjects’ treating clinicians according to clinical standards. Patients may be enrolled receiving any of the following: erenumab (Aimovig), galcanezumab (Emgality), or fremanazumab (Ajovy). It is clinically important to determine whether there is musculoskeletal effects as a class, as well as for the subclasses of CGRP antibodies versus the CGRP receptor antibody (erenumab), or for individual agents in this class. The current grant mechanism does not cover a study large enough to assess whether effects of the different agents or subclasses have truly different magnitudes of musculoskeletal effect. If an effect is seen for a particular agent or subclass, we would then propose a future larger multicenter study to parse differences in magnitude of effect. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Migraine
  • Age: 13 years - 100 years
  • Gender: All

Inclusion Criteria:
Adult cohort
  • • Males or females aged 18 or over at enrollment
  • • Established diagnosis of migraine
  • • Plan to initiate treatment with an anti- CGRP or CGRP-R monoclonal antibody for at least one year
  • Adolescent cohort
  • • Males or females aged 13-17 at enrollment
  • • Established diagnosis of migraine
  • Plan to initiate treatment with an anti or CGRP-R monoclonal antibody for at least one year

  • Exclusion Criteria:
  • • CKD stage 4 or 5
  • • Treatment with any osteoporosis medications
  • • Chronic glucocorticoid treatment beyond topical or inhaled glucocorticoids or maintenance replacement doses of hydrocortisone for adrenal insufficiency.
  • • Current treatment with growth hormone or IGF-1 
  • • Currently pregnancy
  • • Conditions that in the opinion of the investigators would interfere with the ability to collect or interpret the data or put the patient at higher safety risk from study procedures.

Updated on 29 Aug 2024. Study ID: NEUR-IIR-CGRP-MIGRAINE, 15928

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