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
  Purpose

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.


Condition Intervention
Hypopituitarism
Pituitary Insufficiency
Growth Hormone Deficiency, Adult
Drug: Somatropin (rDNA origin)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Global Hypopituitary Control and Complications Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • Number of Participants Who Died While in the Study [ Time Frame: Study enrollment up to approximately 10 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 10673
Study Start Date: September 2002
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Somatropin replacement treatment
Adult participants with growth hormone deficiency receiving somatropin replacement treatment.
Drug: Somatropin (rDNA origin)
Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.
Other Names:
  • Humatrope
  • LY137998
No treatment
Adult participants with growth hormone deficiency receiving no somatropin replacement treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinics, private practices

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088399

Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088399     History of Changes
Other Study ID Numbers: 6448, B9R-MC-GDGA
Study First Received: February 25, 2010
Results First Received: January 13, 2014
Last Updated: March 25, 2014
Health Authority: Austria: Ethikkommission
Belgium: Institutional Review Board
Canada: Ethics Review Committee
Czech Republic: Ethics Committee
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
Italy: Ethics Committee
Japan: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare
Netherlands: Independent Ethics Committee
Spain: Ministry of Health
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism, Pituitary
Hypopituitarism
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on October 29, 2014