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: February 26, 2013
Last verified: February 2013

February 25, 2010
February 26, 2013
September 2002
December 2012   (final data collection date for primary outcome measure)
Clinically significant adverse events during somatropin replacement therapy. [ Time Frame: At interim timepoints and at study completion ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01088399 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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 patients with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The patients 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 patient in consultation with their attending physician.

While treatment of adult growth hormone deficient patients 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 patients 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 patient 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 patient basis.
Other Names:
  • Humatrope
  • LY137998
  • Somatropin replacement treatment
    Adult patients with growth hormone deficiency receiving somatropin replacement treatment.
    Intervention: Drug: Somatropin (rDNA origin)
  • No treatment
    Adult patients with growth hormone deficiency receiving no somatropin replacement treatment.
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. Epub 2011 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8000
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
February 2013

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