AcromegalyPhase 4NCT01424241
Effects of Sandostatin LAR® in Acromegaly
A Phase 4 study testing Sandostatin LAR in people with Acromegaly, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Sandostatin LAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ,
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- not pregnant (as evidence by negative serum pregnancy test) or lactating; and
- If childbearing potential, agree to use a medically acceptable form of contraception (such as oral, implantable, or barrier contraception) from the screening, for the duration of the study, and for at least on month after study discontinuation or completion. Childbearing potential is defined as women who are not surgically sterile or not at least one year postmenopausal.
- 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
Who cannot join
- Have other conditions that may result in abnormal growth hormone (GH) and/or IGF-1 concentrations (e.g., severe hepatic disease, severe renal disease Malnutrition, treatment with levodopa)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x Upper limit of normal or clinically significant hepatic disease
- Prior somatostatin analog therapy within 6 months of the screening visit
- Other medical therapy for acromegaly for 6 weeks to screening visit
- Visual field defects or other neurological symptoms due to tumor mass
- Have known or suspected drug or alcohol abuse
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- Have received an investigational medication within four week prior to screening or is scheduled to received any investigational medication during the study
- Do not have ability to fully comprehend the nature of the study, to follow instructions, cooperate with study procedures, and/or are unable to adhere to the visit scheduled outlined in the protocol
- Have other severe acute or chronic medical or psychiatry condition or Laboratory abnormality that may increase the risk associated with study Participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- Patient who have known hypersensitivity to Sandostatin acetate or other related drug or compound
- Patient with current gallstones
- Patient who have received supraphysiologic doses of glucocorticoid within the past 6 months (except for peri-operative (<3 days duration) of dexamethasone) or who currently received chemotherapeutics agents, or exogenous growth hormone
- Patients who have received other investigational drugs administered or Received within 30 days of study entry
- Patients who exhibit symptoms indicative of intolerance during the 2 weeks Course of Sandostatin injection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Metabolic, Cardiovascular and Body Composition Effects of Sandostatin LAR® Therapy of Acromegaly, Effect of Reduction of Serum Insulin-like Growth Factor 1 (IGF-1) Levels Into a New Normative Range
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.
Read the detailed description
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.
- Conditions
- Acromegaly
- Being tested
- Sandostatin LAR
- Keywords
- Sandostatin LAR
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandostatin LARDrug
Open label dose escalation of Sandostatin LAR 10 mg, 20 mg, 30 mg, up to 40 mg if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Sandostatin LAR | Experimental | Nine months of open label dose escalation Sandostatin LAR therapy. Receives: Drug: Sandostatin LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 9 months
Secondary outcomes (3)
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.
Measured: Up to 9 months
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.
Measured: 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.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startOct 2006
- Primary completionMar 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Pamela U. Freda, Columbia University
- Investigators
- Pamela U Freda, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424241
- Sponsor's protocol ID
- AAAC0246
- Other IDs
- CSMS995BUS57
- Status last verified
- Jul 2024
- First submitted
- 19 Aug 2011
- Last updated
- 24 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic, Cardiovascular and Body Composition Effects of Sandostatin LAR® Therapy of Acromegaly, Effect of Reduction of Serum Insulin-like Growth Factor 1 (IGF-1) Levels Into a New Normative Range
- ClinicalTrials.gov ID
- NCT01424241
- Acronym / sponsor ID
- AAAC0246
- Conditions
- Acromegaly
- Keywords
- Sandostatin LAR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2006
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Posted 24 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sandostatin LAR | Experimental | Drug: Sandostatin LARNine months of open label dose escalation Sandostatin LAR therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- Have other conditions that may result in abnormal growth hormone (GH) and/or IGF-1 concentrations (e.g., severe hepatic disease, severe renal disease Malnutrition, treatment with levodopa)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x Upper limit of normal or clinically significant hepatic disease
- Prior somatostatin analog therapy within 6 months of the screening visit
- Other medical therapy for acromegaly for 6 weeks to screening visit
- Visual field defects or other neurological symptoms due to tumor mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandostatin LAROpen label dose escalation of Sandostatin LAR 10 mg, 20 mg, 30 mg, up to 40 mg if necessary. | Drug | Sandostatin LAR |
Primary outcome
IGF-1 Level on Sandostatin LAR
Time frame: Up to 9 months
Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)
3 secondary outcomes
Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels
Time frame: Up to 9 months
Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels
Time frame: Up to 9 months
Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels
Time frame: Up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Acromegaly
RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela U Freda, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sandostatin LAR in people with Acromegaly, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGF-1 Level on Sandostatin LAR (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.