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Trial · Interventional

CompletedPhase 4Registry data

Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly

Short name HDacro

NCTNCT00461149 (opens ClinicalTrials.gov in a new tab)Other idNeuroendoUnit-1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
50 participants
Sponsor
Federico II University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Italy

Start
Jan 1995
Primary completion
Not stated
Completion
Dec 2006
First posted
17 Apr 2007 (estimated)
Last update posted
17 Apr 2007 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
199619982000200220042006
  1. Ph 4

    HDacro

    NCT00461149

    Jan 1995 to Dec 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Epidemiological data indicate that patients with active acromegaly have reduced life expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A post-treatment GH value \<5 mU/liter (equal to \<2.5 μg/liter) and IGF-I in the normal range for age are recognized as the most predictive survival indices. Since their introduction into clinical use approximately two decades ago, somatostatin analogs have been considered a cornerstone of medical therapy for acromegaly. After 12 months of treatment with octreotide-LAR, control of GH and IGF-I excess, is achieved in 54% and 63% of unselected patients (11). The proportion of subjects achieving IGF-I normalization increases significantly with time (12). Significant tumor shrinkage has also been reported in a number of studies (13,14): an average 50% tumor decrease is achieved when the drug is used exclusively, or before surgery or radiotherapy (14). In 99 unselected newly diagnosed patients after 12 months of treatment with somatostatin analogues we reported control of GH levels in 57.6% and IGF-I levels in 45.5% and a greater than 50% tumor shrinkage in 44.4% (15). The dose of LAR in different studies ranged from 10-40 mg every 28 days (q28d): high doses are generally administered in patients who do not control GH and IGF-I excess with lower doses. As reported in the meta-analysis (11) the rate of IGF-I normalization tended to be lower as octreotide-LAR dose was raised: 90% in patients treated with 10 mg, 61% with 20 mg and 53% with 30 mg. However, some further benefit by increasing the dose of octreotide-LAR was reported in some studies (16-18). Data on dose escalation of octreotide-LAR given as first-line therapy in newly diagnosed patients with acromegaly are lacking.

Interventions

  • Octreotide-LARDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. GH and IGF-I control

  2. tumor shrinkage

Secondary outcomes(1)

  1. Glucose tolerance.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies10

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 1999

5 results

A comparison of lanreotide and octreotide LAR for treatment of acromegaly.

Turner et al. 1999Clinical endocrinologycited by 49

PMID 10469005DOI 10.1046/j.1365-2265.1999.00853.xPUB-10469005

Full text at the publisher5 results
Publisher pageSee results (5)

More studies

9 studies on this page

Indexing hint: Observational study · 2007

Beneficial effect of dose escalation of octreotide-LAR as first-line therapy in patients with acromegaly.

Colao et al. 2007European journal of endocrinologycited by 60

PMID 17984237DOI 10.1530/eje-07-0383PUB-17984237

Full text at the publisher
Publisher page

Indexing hint: Clinical trial · 2006

Primary treatment of acromegaly with octreotide LAR: a long-term (up to nine years) prospective study of its efficacy in the control of disease activity and tumor shrinkage.

Cozzi et al. 2006The Journal of clinical endocrinology and metabolismcited by 130

PMID 16449332DOI 10.1210/jc.2005-2347PUB-16449332

Full text at the publisher
Publisher page

PubMed tag: none · 2006

First-line octreotide-LAR therapy induces tumour shrinkage and controls hormone excess in patients with acromegaly: results from an open, prospective, multicentre trial.

Colao et al. 2006Clinical endocrinologycited by 47

PMID 16487447DOI 10.1111/j.1365-2265.2006.02467.xPUB-16487447

Rights unknown
Source link

PubMed tag: none · 2006

Predictors of tumor shrinkage after primary therapy with somatostatin analogs in acromegaly: a prospective study in 99 patients.

Colao et al. 2006The Journal of clinical endocrinology and metabolismcited by 83

PMID 16537687DOI 10.1210/jc.2005-2110PUB-16537687

Full text at the publisher
Publisher page

PubMed tag: none · 2005

A critical analysis of pituitary tumor shrinkage during primary medical therapy in acromegaly.

Melmed et al. 2005The Journal of clinical endocrinology and metabolismcited by 134

PMID 15827109DOI 10.1210/jc.2004-2466PUB-15827109

Rights unknown
Source link

Indexing hint: Meta-analysis (pooled) · 2005

Long-acting somatostatin analog therapy of acromegaly: a meta-analysis.

Freda et al. 2005The Journal of clinical endocrinology and metabolismcited by 220

PMID 15886238DOI 10.1210/jc.2005-0260PUB-15886238

Full text at the publisher
Publisher page

PubMed tag: none · 2003

Four-year treatment with octreotide-long-acting repeatable in 110 acromegalic patients: predictive value of short-term results?

Cozzi et al. 2003The Journal of clinical endocrinology and metabolismcited by 131

PMID 12843148DOI 10.1210/jc.2003-030110PUB-12843148

Rights unknown
Source link

PubMed tag: none · 2001

Long-term effects of depot long-acting somatostatin analog octreotide on hormone levels and tumor mass in acromegaly.

Colao et al. 2001The Journal of clinical endocrinology and metabolismcited by 181

PMID 11397887DOI 10.1210/jcem.86.6.7556PUB-11397887

Rights unknown
Source link

Indexing hint: Clinical trial · 2000

Cardiovascular effects of depot long-acting somatostatin analog Sandostatin LAR in acromegaly.

Colao et al. 2000The Journal of clinical endocrinology and metabolismcited by 78

PMID 10999798DOI 10.1210/jcem.85.9.6782PUB-10999798

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultWright AD, Hill DM, Lowy C, Fraser TR. Mortality in acromegaly. Q J Med. 1970 Jan;39(153):1-16. No abstract available. PMID 5427331
  • ResultBates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9. PMID 8327647
  • ResultEtxabe J, Gaztambide S, Latorre P, Vazquez JA. Acromegaly: an epidemiological study. J Endocrinol Invest. 1993 Mar;16(3):181-7. doi: 10.1007/BF03344942. PMID 8514973
  • ResultRajasoorya C, Holdaway IM, Wrightson P, Scott DJ, Ibbertson HK. Determinants of clinical outcome and survival in acromegaly. Clin Endocrinol (Oxf). 1994 Jul;41(1):95-102. doi: 10.1111/j.1365-2265.1994.tb03789.x. PMID 8050136
  • ResultAbosch A, Tyrrell JB, Lamborn KR, Hannegan LT, Applebury CB, Wilson CB. Transsphenoidal microsurgery for growth hormone-secreting pituitary adenomas: initial outcome and long-term results. J Clin Endocrinol Metab. 1998 Oct;83(10):3411-8. doi: 10.1210/jcem.83.10.5111. PMID 9768640
  • ResultSwearingen B, Barker FG 2nd, Katznelson L, Biller BM, Grinspoon S, Klibanski A, Moayeri N, Black PM, Zervas NT. Long-term mortality after transsphenoidal surgery and adjunctive therapy for acromegaly. J Clin Endocrinol Metab. 1998 Oct;83(10):3419-26. doi: 10.1210/jcem.83.10.5222. PMID 9768641
  • ResultOrme SM, McNally RJ, Cartwright RA, Belchetz PE. Mortality and cancer incidence in acromegaly: a retrospective cohort study. United Kingdom Acromegaly Study Group. J Clin Endocrinol Metab. 1998 Aug;83(8):2730-4. doi: 10.1210/jcem.83.8.5007. PMID 9709939
  • ResultAyuk J, Clayton RN, Holder G, Sheppard MC, Stewart PM, Bates AS. Growth hormone and pituitary radiotherapy, but not serum insulin-like growth factor-I concentrations, predict excess mortality in patients with acromegaly. J Clin Endocrinol Metab. 2004 Apr;89(4):1613-7. doi: 10.1210/jc.2003-031584. PMID 15070920
  • ResultHoldaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74. doi: 10.1210/jc.2003-031199. PMID 14764779
  • ResultKauppinen-Makelin R, Sane T, Reunanen A, Valimaki MJ, Niskanen L, Markkanen H, Loyttyniemi E, Ebeling T, Jaatinen P, Laine H, Nuutila P, Salmela P, Salmi J, Stenman UH, Viikari J, Voutilainen E. A nationwide survey of mortality in acromegaly. J Clin Endocrinol Metab. 2005 Jul;90(7):4081-6. doi: 10.1210/jc.2004-1381. Epub 2005 May 10. PMID 15886256
  • ResultBevan JS. Clinical review: The antitumoral effects of somatostatin analog therapy in acromegaly. J Clin Endocrinol Metab. 2005 Mar;90(3):1856-63. doi: 10.1210/jc.2004-1093. Epub 2004 Dec 21. PMID 15613435
  • ResultColao A, Lombardi G. Growth-hormone and prolactin excess. Lancet. 1998 Oct 31;352(9138):1455-61. doi: 10.1016/S0140-6736(98)03356-X. PMID 9808008
  • ResultGiustina A, Barkan A, Casanueva FF, Cavagnini F, Frohman L, Ho K, Veldhuis J, Wass J, Von Werder K, Melmed S. Criteria for cure of acromegaly: a consensus statement. J Clin Endocrinol Metab. 2000 Feb;85(2):526-9. doi: 10.1210/jcem.85.2.6363. PMID 10690849

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * patients with newly diagnosed acromegaly * age above 18 years * no previous treatments for acromegaly Exclusion Criteria: * primary surgery * concomitant hyperprolactinemia if requiring combined treatment with dopamine-agonist * primary treatment with lanreotide * treatment duration less than 24 months

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