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

Condition(s) targeted: Hypopituitarism; Pituitary Insufficiency; Growth Hormone Deficiency, Adult

Intervention: Somatropin (rDNA origin) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: The Global Hypopituitary Control and Complications Study

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Clinically Significant Adverse Events

Secondary outcome:

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

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

Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides

Cardiovascular Risk Factor-Change From Baseline in Waist Circumference

Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)

Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: September 2002
Last updated: March 25, 2014