Clinical trial NCT01088399: A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults
Official title: The Global Hypopituitary Control and Complications Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypopituitarism
Pituitary Insufficiency
Growth Hormone Deficiency, Adult
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 10673
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinics, private practices

Brief 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.


Eligibility 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

Primary outcomes:
measure: Clinically Significant Adverse Events
timeFrame: Baseline to study completion (approximately 10 years)
Secondary outcomes:
measure: Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, interim time point (5 years), and study completion (10 years)
measure: Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline, interim time point (5 years), and study completion (10 years)
measure: Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides
timeFrame: Baseline, interim time point (5 years), and study completion (10 years)
measure: Cardiovascular Risk Factor-Change From Baseline in Waist Circumference
timeFrame: Baseline, interim time point (5 years), and study completion (10 years)
measure: Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)
timeFrame: Baseline through 10 years
measure: Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).
timeFrame: Baseline, interim time point (5 years), and study completion (10 years)
Other outcomes:
measure: Number of Participants Who Died While in the Study
timeFrame: Study enrollment up to approximately 10 years
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Mo D, Blum WF, Rosilio M, Webb SM, Qi R, Strasburger CJ. Ten-year change in quality of life in adults on growth hormone replacement for growth hormone deficiency: an analysis of the hypopituitary control and complications study. J Clin Endocrinol Metab. 2014 Dec;99(12):4581-8. doi: 10.1210/jc.2014-2892.
citation: Mo D, Hardin DS, Erfurth EM, Melmed S. Adult mortality or morbidity is not increased in childhood-onset growth hormone deficient patients who received pediatric GH treatment: an analysis of the Hypopituitary Control and Complications Study (HypoCCS). Pituitary. 2014 Oct;17(5):477-85. doi: 10.1007/s11102-013-0529-6.
citation: Shimatsu A, Tai S, Imori M, Ihara K, Taketsuna M, Funai J, Tanaka T, Teramoto A, Irie M, Chihara K. Efficacy and safety of growth hormone replacement therapy in Japanese adults with growth hormone deficiency: a post-marketing observational study. Endocr J. 2013;60(10):1131-44. doi: 10.1507/endocrj.ej13-0083. Epub 2013 Jul 4.
citation: 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. doi: 10.1210/jc.2011-0448. Epub 2011 May 4.