A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults

NCT ID: NCT01088399

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10673 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2012-12-31

Brief Summary

The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. The objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient participants with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The participant enrolled meet the criteria of growth hormone deficiency in adults as per the Humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. The decision to receive somatropin or remain untreated is made by the participant in consultation with their attending physician.

While treatment of adult growth hormone deficient participants with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of participants in the context of the overall disease environment.

Conditions

Hypopituitarism; Pituitary Insufficiency; Growth Hormone Deficiency, Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Somatropin replacement treatment

Adult participants with growth hormone deficiency receiving somatropin replacement treatment.

Somatropin (rDNA origin)

Intervention Type: DRUG

Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.

No treatment

Adult participants with growth hormone deficiency receiving no somatropin replacement treatment.

No interventions assigned to this group

Interventions

Somatropin (rDNA origin)

Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.

Intervention Type: DRUG

Other Intervention Names

Humatrope; LY137998

Eligibility Criteria

Inclusion Criteria

• Adult growth hormone deficiency as per the local Humatrope label and as judged by the attending physician

Exclusion Criteria

• As per the local Humatrope label and as judged by the attending physician

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

References

Mo D, Blum WF, Rosilio M, Webb SM, Qi R, Strasburger CJ. Ten-year change in quality of life in adults on growth hormone replacement for growth hormone deficiency: an analysis of the hypopituitary control and complications study. J Clin Endocrinol Metab. 2014 Dec;99(12):4581-8. doi: 10.1210/jc.2014-2892.

Reference Type: DERIVED

PMID: 25233155 (View on PubMed)

Mo D, Hardin DS, Erfurth EM, Melmed S. Adult mortality or morbidity is not increased in childhood-onset growth hormone deficient patients who received pediatric GH treatment: an analysis of the Hypopituitary Control and Complications Study (HypoCCS). Pituitary. 2014 Oct;17(5):477-85. doi: 10.1007/s11102-013-0529-6.

Reference Type: DERIVED

PMID: 24122237 (View on PubMed)

Shimatsu A, Tai S, Imori M, Ihara K, Taketsuna M, Funai J, Tanaka T, Teramoto A, Irie M, Chihara K. Efficacy and safety of growth hormone replacement therapy in Japanese adults with growth hormone deficiency: a post-marketing observational study. Endocr J. 2013;60(10):1131-44. doi: 10.1507/endocrj.ej13-0083. Epub 2013 Jul 4.

Reference Type: DERIVED

PMID: 23823978 (View on PubMed)

Attanasio AF, Jung H, Mo D, Chanson P, Bouillon R, Ho KK, Lamberts SW, Clemmons DR; HypoCCS International Advisory Board. Prevalence and incidence of diabetes mellitus in adult patients on growth hormone replacement for growth hormone deficiency: a surveillance database analysis. J Clin Endocrinol Metab. 2011 Jul;96(7):2255-61. doi: 10.1210/jc.2011-0448. Epub 2011 May 4.

Reference Type: DERIVED

PMID: 21543424 (View on PubMed)

Other Identifiers

B9R-MC-GDGA

Identifier Type: OTHER

Identifier Source: secondary_id

6448

Identifier Type: -

Identifier Source: org_study_id