A Phase 4 interventional study of Sandostatin LAR in Acromegaly, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
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.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 21 is below the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
if female ,
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nine months of open label dose escalation Sandostatin LAR therapy.
Drug: Sandostatin LAR
Open label dose escalation of Sandostatin LAR 10 mg, 20 mg, 30 mg, up to 40 mg if necessary.
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)
Time frame: Up to 9 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 9 months
| Milestone | Open Label Dose Escalation Study of Sandostatin LAR Therapy |
|---|---|
| Started | 21 |
| Completed | 18 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Time constraints | 2 |
Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)
| ng/mL | Open Label Dose Escalation of Sandostatin LAR Therapy | Responders | Non Responders |
|---|---|---|---|
| IGF-1 Level on Sandostatin LAR | 336 ± 209 | 186 ± 42.4 | 487 ± 200.4 |
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.
| mg/L | Open Label Dose Escalation of Sandostatin LAR Therapy | Responders | Non Responders |
|---|---|---|---|
| Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels | 2.05 ± 3.5 | 2.89 ± 4.79 | 1.21 ± 1.2 |
Levels of homocysteine in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.
| µmol/L | Open Label Dose Escalation of Sandostatin LAR Therapy | Responders | Non Responders |
|---|---|---|---|
| Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels | 9.98 ± 5.8 | 10.57 ± 5.56 | 9.40 ± 6.4 |
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.
| mg/dL | Open Label Dose Escalation of Sandostatin LAR Therapy | Responders | Non Responders |
|---|---|---|---|
| Total cholesterol | 173.75 ± 42.9 | 182.44 ± 49.78 | 162.57 ± 32.1 |
| LDL cholesterol | 101.56 ± 40.7 | 108.7 ± 45.38 | 92.43 ± 34.9 |
| HDL Cholesterol | 52.17 ± 14.6 | 53.44 ± 16.19 | 50.89 ± 13.6 |
| Triglycerides | 95.2 ± 36.2 | 88.38 ± 38.13 | 103 ± 35.1 |
| Lipoprotein a | 55.31 ± 68.9 | 71.45 ± 85.95 | 34.56 ± 33.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label Dose Escalation Study of Sandostatin LAR Therapy | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Open Label Dose Escalation Study of Sandostatin LAR Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 2 |
| Age, Continuous(years) | Open Label Dose Escalation Study of Sandostatin LAR Therapy |
|---|---|
| Mean | 44.9 (19 to 80) |
| Sex: Female, Male(Participants) | Open Label Dose Escalation Study of Sandostatin LAR Therapy |
|---|---|
| Female | 11 |
| Male | 10 |
| Region of Enrollment(participants) | Open Label Dose Escalation Study of Sandostatin LAR Therapy |
|---|---|
| United States | 21 |
| IGF-1 Level(ng/ml) | Open Label Dose Escalation Study of Sandostatin LAR Therapy |
|---|---|
| Mean | 336 (287 to 385) |
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Oct 2006, a primary completion of Mar 2013 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2024, 11 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Octreotide