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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088399
First received: February 25, 2010
Last updated: March 25, 2014
Last verified: March 2014

February 25, 2010
March 25, 2014
September 2002
December 2012   (final data collection date for primary outcome measure)
Clinically Significant Adverse Events [ Time Frame: Baseline to study completion (approximately 10 years) ] [ Designated as safety issue: Yes ]
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.
Clinically significant adverse events during somatropin replacement therapy. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01088399 on ClinicalTrials.gov Archive Site
  • Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, interim time point (5 years), and study completion (10 years) ] [ Designated as safety issue: Yes ]
    Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.
  • Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, interim time point (5 years), and study completion (10 years) ] [ Designated as safety issue: Yes ]
    Change in SBP and DBP were used as an indicator of cardiovascular risk.
  • Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides [ Time Frame: Baseline, interim time point (5 years), and study completion (10 years) ] [ Designated as safety issue: Yes ]
    Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented.
  • Cardiovascular Risk Factor-Change From Baseline in Waist Circumference [ Time Frame: Baseline, interim time point (5 years), and study completion (10 years) ] [ Designated as safety issue: Yes ]
    Change in waist circumference was used as an indicator of cardiovascular risk.
  • Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence) [ Time Frame: Baseline through 10 years ] [ Designated as safety issue: Yes ]
  • Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H). [ Time Frame: Baseline, interim time point (5 years), and study completion (10 years) ] [ Designated as safety issue: No ]
    QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction).
  • Evaluate long-term benefits of somatropin replacement therapy with regard to cardiovascular risk factors. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
  • Evaluate long-term benefits of somatropin replacement therapy with regard to fracture incidence. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
  • Evaluate long-term benefits of somatropin replacement therapy with regard to quality of life as assessed by a disease-specific module of the Questions of Life Satisfaction (QLS-H). [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: No ]
Number of Participants Who Died While in the Study [ Time Frame: Study enrollment up to approximately 10 years ] [ Designated as safety issue: Yes ]
Not Provided
 
A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults
The Global Hypopituitary Control and Complications Study

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Clinics, private practices

  • Hypopituitarism
  • Pituitary Insufficiency
  • Growth Hormone Deficiency, Adult
Drug: Somatropin (rDNA origin)
Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.
Other Names:
  • Humatrope
  • LY137998
  • Somatropin replacement treatment
    Adult participants with growth hormone deficiency receiving somatropin replacement treatment.
    Intervention: Drug: Somatropin (rDNA origin)
  • No treatment
    Adult participants with growth hormone deficiency receiving no somatropin replacement treatment.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10673
December 2012
December 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01088399
6448, B9R-MC-GDGA
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP