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MACRO Registry


Title The Management of Acromegaly (MACRO) Registry
Therapeutic Area Acromegaly
Principal Investigator Dr. Ronald Lechan
Min Age 18 Years
Gender All
Contact Cindy Haviet
617-636-3273
chaviet@tuftsmedicalcenter.org

Overview

The MACRO registry will collect data prospectively on patients with active acromegaly, defined operationally as an adult patient with a confirmed diagnosis of acromegaly being treated with medical therapy; or eligible to be treated with medical therapy, e.g., having an elevated IGF-1. This is an observational study; therefore, no additional visits or laboratory tests will be required outside of local routine clinical practice. Dosing and duration of medical therapies is at the discretion of the treating physician, in accordance with local labeling.

Study Details

Inclusion Criteria

  • Male or female patients living in the US, aged ≥ 18 years old.
  • Have activeacromegaly,thatis,currentlyonmedicaltherapyforacromegaly;oreligible for medical therapy (e.g., having an elevated IGF-1). Current medical therapies could include:
    • Octreotide LAR (Sandostatin® LAR Depot
    • Lanreotide (Somatuline® Depot)
    • Pasireotide LAR (Signifor®)
    • Cabergoline capsules (Dostinex®)(/li>
    • Bromocriptine capsules (Parlodel®)
    • Pegvisomant (Somavert®)
  • Have visited their treating physician for acromegaly within the past 15 months from the informed consent signing date.

Exclusion Criteria

  • Participating in any other acromegaly clinical or investigational trial involving a medical therapy.

Study Requirements

Following informed consent, patients will complete a questionnaire at Baseline, and then every 3 months for up to 3 years for a total of 13 questionnaires. All patients will be followed for up to 3 years, unless study is extended.