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

Hypopituitarism Clinical Trial

— HypoCCS  

Official title:

The Global Hypopituitary Control and Complications Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088399
• Other study ID #: 6448
• Secondary ID: B9R-MC-GDGA
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: March 25, 2014
• Start date: September 2002
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Institutional Review BoardCanada: Ethics Review CommitteeCzech Republic: Ethics CommitteeFrance: French Data Protection AuthorityFrance: Haute Autorité de Santé Transparency CommissionGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyHungary: Research Ethics Medical CommitteeItaly: Ethics CommitteeJapan: Institutional Review BoardJapan: Ministry of Health, Labor and WelfareNetherlands: Independent Ethics CommitteeSpain: Ministry of HealthSpain: Ethics CommitteeSweden: Regional Ethical Review BoardSweden: Medical Products AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10673
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency, Adult
• Hypopituitarism
• Pituitary Insufficiency

Intervention

Drug:
• Somatropin (rDNA origin)
Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Died While in the Study		Study enrollment up to approximately 10 years	Yes
Primary	Clinically Significant Adverse Events	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.	Baseline to study completion (approximately 10 years)	Yes
Secondary	Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)	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.	Baseline, interim time point (5 years), and study completion (10 years)	Yes
Secondary	Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)	Change in SBP and DBP were used as an indicator of cardiovascular risk.	Baseline, interim time point (5 years), and study completion (10 years)	Yes
Secondary	Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides	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.	Baseline, interim time point (5 years), and study completion (10 years)	Yes
Secondary	Cardiovascular Risk Factor-Change From Baseline in Waist Circumference	Change in waist circumference was used as an indicator of cardiovascular risk.	Baseline, interim time point (5 years), and study completion (10 years)	Yes
Secondary	Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)		Baseline through 10 years	Yes
Secondary	Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).	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).	Baseline, interim time point (5 years), and study completion (10 years)	No