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Completed

NCT Number: NCT01088399

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

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.

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Key information

Conditions

Hypopituitarism Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Growth Hormone Deficiency, Adult Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases Pituitary Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin (rDNA origin)

Drug

Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.

Other names: Humatrope, LY137998

Primary outcomes

  1. Clinically Significant Adverse Events

    Time frame: Baseline to study completion (approximately 10 years)

    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

  1. Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)

    Time frame: Baseline, interim time point (5 years), and study completion (10 years)

    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.

  2. 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)

    Change in SBP and DBP were used as an indicator of cardiovascular risk.

  3. Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides

    Time frame: Baseline, interim time point (5 years), and study completion (10 years)

    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.

  4. Cardiovascular Risk Factor-Change From Baseline in Waist Circumference

    Time frame: Baseline, interim time point (5 years), and study completion (10 years)

    Change in waist circumference was used as an indicator of cardiovascular risk.

  5. Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)

    Time frame: Baseline through 10 years

  6. 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)

    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 outcomes

  1. Number of Participants Who Died While in the Study

    Time frame: Study enrollment up to approximately 10 years

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Global Hypopituitary Control and Complications Study

Acronym: HypoCCS

Important dates

Study start
2002
Primary completion
2012
Study completion
2012
First posted
Mar 17, 2010
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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