N/A
N=10,673
A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults
Hypopituitarism · Pituitary Insufficiency · Growth Hormone Deficiency, Adult
Bottom Line
View on ClinicalTrials.gov: NCT01088399 ↗Enrolled (actual)
10,673
Serious AEs
19.5%
Results posted
Apr 2014
Primary outcome: Primary: Clinically Significant Adverse Events — 2.58; 3.78; 4.0; 5.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Somatropin (rDNA origin) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Significant Adverse Events |
2.58; 3.78; 4.0; 5.3; 0.8; 1.4 | — |
| SECONDARY Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI) |
0.63; -0.10; 1.14; -0.32 | — |
| SECONDARY Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP) |
1.04; -0.48; 1.98; 3.71; -0.85; -0.76 | — |
| SECONDARY Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides |
-13.0; -14.6; -17.9; -43.1; 1.47; -0.54 | — |
| SECONDARY Cardiovascular Risk Factor-Change From Baseline in Waist Circumference |
0.85; 0.10; 3.57; 3.03 | — |
| SECONDARY Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence) |
3.75; 4.02; 0.00 | — |
| SECONDARY Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H). |
0.70; 0.21; 0.53; -1.01 | — |
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
Data sourced from ClinicalTrials.gov (NCT01088399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.