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

NCT01088399 | Completed Results

• 2 other identifiers: 6448B9R-MC-GDGA
• Study Type: observational
• Target: 10,673
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Clinically Significant Adverse Events

  A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.

  Baseline to study completion (approximately 10 years)

Secondary Outcomes (6)

• Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)

  Baseline, interim time point (5 years), and study completion (10 years)

• Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)

  Baseline, interim time point (5 years), and study completion (10 years)

• Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides

  Baseline, interim time point (5 years), and study completion (10 years)

• Cardiovascular Risk Factor-Change From Baseline in Waist Circumference

  Baseline, interim time point (5 years), and study completion (10 years)

• Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)

  Baseline through 10 years

Other Outcomes (1)

• Number of Participants Who Died While in the Study

  Study enrollment up to approximately 10 years

Study Arms (2)

Somatropin replacement treatment

Adult participants with growth hormone deficiency receiving somatropin replacement treatment.

Drug: Somatropin (rDNA origin)

No treatment

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

Interventions

Somatropin (rDNA origin) DRUG

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

Also known as: Humatrope, LY137998

Somatropin replacement treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinics, private practices

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Related Publications (4)

• 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.

  PMID: 25233155 DERIVED

• 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.

  PMID: 24122237 DERIVED

• 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.

  PMID: 23823978 DERIVED

• 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.

  PMID: 21543424 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA Addendum - implemented in Germany only. Germany: DNA sample is kept, if participant consented to German DNA Addendum

MeSH Terms

Conditions

Hypopituitarism; Dwarfism, Pituitary

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 17, 2010
• Study Start: September 1, 2002
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03