Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on the pituitary gland, which leads to excessive production of growth hormone (GH). GH excess in turn causes overproduction of another hormone called insulin-like growth factor-1 (IGF-1). IGF-1 levels are currently the most widely accepted measure of disease activity.
In Canada, medical therapy with a type of medicine called "somatostatin analogues" (SSA), such as octreotide and lanreotide, is recommended for treatment of acromegaly. However, studies have shown that a significant number of patients who take SSA medications alone remain with elevated levels of IGF-1 in their blood.
Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the investigators plan to study whether strict control of IGF-1, by adding or optimizing the use of PEGV, results in a significant health benefits to patients who still have modestly high levels of IGF-1 in their blood.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegvisomant | Experimental | Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegvisomant | Drug | Study medications will be prescribed as per clinical practice with PEGV being added, or optimally dosed, at the Month 0 visit. Subjects who are naïve to PEGV should start their injections from 10 mg twice a week to 10 mg daily if used as combination therapy or 10 to 20 mg daily if used as monotherapy. Maximum dosing should not exceed 40mg/day. Dosing of PEGV can be adjusted as per clinical judgement to meet the normalization of IGF-1 levels (<1.0 ULN) in increments of 5-10mg/day. In the event of a reduction in IGF-1 below the LLN, the dose of PEGV could be decreased by 5-10 mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (AcroQoL) | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IGF-1 level | six months | |
| Acromegaly Disease Activity Tool (ACRODAT) | To assess acromegaly co-morbidities | six months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Constance Chik, MD | St. Michael's Hospital, Toronto, ON | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada | ||
| St. Joseph Health Care London |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
Not provided
Not provided
| ID | Term |
|---|---|
| C406545 | pegvisomant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Patient-assessed Acromegaly Symptom Questionnaire |
To assess acromegaly signs and symptoms |
| six months |
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | six months |
| London |
| Ontario |
| N6A4V2 |
| Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 7W9 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Centre hospitalier universitaire de Québec-Université Laval | Québec | Quebec | G1V 4G2 | Canada |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |