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

Short name HypoCCS

NCTNCT01088399Other id6448Other idB9R-MC-GDGA

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Overview

Status: Completed
Phase: Phase not stated
Enrollment: 10,673 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Not stated
Countries: Not stated
Start: Sept 2002
Primary completion: Dec 2012
Completion: Dec 2012
First posted: 17 Mar 2010 (estimated)
Last update posted: 21 Apr 2014 (estimated)
Conditions: Hypopituitarism · Pituitary Insufficiency · Growth Hormone Deficiency, Adult

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200220042006200820102012

Ph –
HypoCCS
NCT01088399
Sept 2002 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Somatropin (rDNA origin)Drug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Clinically Significant Adverse Events
Time frame · Baseline to study completion (approximately 10 years)
Registry description
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 outcomes(6)

Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)
Time frame · Baseline, interim time point (5 years), and study completion (10 years)
Registry description
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)
Registry description
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)
Registry description
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)
Registry description
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
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)
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline to study completion (approximately 10 years)