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| ID | Type | Description | Link |
|---|---|---|---|
| CSMS995BUS57 | Other Grant/Funding Number | Novartis Pharmaceutical, Inc./Investigator Initiated study |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF-1) normalization into current IGF-I normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.
A major goal of treatment of acromegaly is to normalize serum IGF-1 levels. Recently developed new normative data for serum IGF-1 levels has lowered the upper limit of normal for this hormone level. Octreotide, an analog of somatostatin, a synthetic form of the hypothalamic hormone somatostatin, which inhibits growth hormone (GH) release by blocking somatostatin receptors in the pituitary and on the tumor, is now available in a long acting depot formulation, Sandostatin LAR, that suppresses tumoral GH secretion and normalizes GH and IGF-1 levels in about 60% of patients. Although sandostatin LAR is Food and Drug Administration (FDA) approved for the therapy of acromegaly and is used clinically, its efficacy with respect to new normative IGF-1 ranges has not been studied. In addition, an important goal of therapy of acromegaly is to treat co-morbidities of the disease such as insulin resistance, which is common in acromegaly. Other important morbidities in acromegaly are hypertension and cardiovascular disease such as left ventricular hypertrophy (LVH). In this study the investigators will assess the effect of LAR therapy on biochemical parameters as well as important clinical endpoints of therapy of acromegaly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sandostatin LAR | Experimental | Nine months of open label dose escalation Sandostatin LAR therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sandostatin LAR | Drug | Open label dose escalation of Sandostatin LAR 10 mg, 20 mg, 30 mg, up to 40 mg if necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 Level on Sandostatin LAR | Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1) | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels | Levels of C-reactive protein (CRP) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome. | Up to 9 months |
| Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels |
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Inclusion Criteria:
Adults (age > 18 years) with diagnosis of Acromegaly ( previously confirmed by an elevated IGF-1 level)
IGF-1 concentrations> 10% above the upper limit of normal at screening
If the patient have undergone surgical resection of a pituitary adenoma, A minimum of two months must have elapsed post surgery prior to enrollment
May have a history of radiotherapy
Stable pituitary hormone supplements(x months) prior to baseline visit
if female ,
Sign and date an consent form document indicating that the subject (or legally acceptable representative) has been informed of and agrees to all pertinent aspects of trial
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela U Freda, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Dose Escalation Study of Sandostatin LAR Therapy | Acromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog. In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk. Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Dose Escalation Study of Sandostatin LAR Therapy | Acromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog. In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk. Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IGF-1 Level on Sandostatin LAR | Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1) | This study was open to adult patients with active acromegaly, either newly diagnosed or failing other therapies who met the following inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | ng/mL | Up to 9 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Dose Escalation Study of Sandostatin LAR Therapy | Acromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog. In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk. Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Freda, MD | Columbia University Medical Center | 212-305-2254 | puf1@columbia.edu |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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Levels of homocysteine in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome. |
| Up to 9 months |
| Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels | Levels of lipid panel (cholesterol, triglycerides, and Lipoprotein A) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome. | Up to 9 months |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| IGF-1 Level | Mean | Full Range | ng/ml |
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| OG002 | Non Responders | Elevated IGF-1 Group |
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| Secondary | Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels | Levels of C-reactive protein (CRP) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome. | Posted | Mean | Standard Deviation | mg/L | Up to 9 months |
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| Secondary | Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels | Levels of homocysteine in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome. | Posted | Mean | Standard Deviation | µmol/L | Up to 9 months |
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| Secondary | Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels | Levels of lipid panel (cholesterol, triglycerides, and Lipoprotein A) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome. | Posted | Mean | Standard Deviation | mg/dL | Up to 9 months |
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| 0 |
| 18 |
| 0 |
| 18 |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| HDL Cholesterol |
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| Triglycerides |
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| Lipoprotein a |
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