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

Browse trials for

• Hypopituitarism 47
• Dwarfism, Pituitary 252

Hypopituitarism

47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.

This study's enrollment of 10,673 is above the median of 137 across 17 observational studies indexed under Hypopituitarism.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Study population

Groups and cohorts

• Somatropin replacement treatment

  Adult participants with growth hormone deficiency receiving somatropin replacement treatment.

  Drug: Somatropin (rDNA origin)

• No treatment

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

Interventions

• DrugSomatropin (rDNA origin)

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

  Also known as: Humatrope, LY137998

Primary outcomes

1. 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.

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

Secondary outcomes

1. 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.

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

2. 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.

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

3. 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.

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

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

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

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

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).

   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).

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

Other outcomes

1. Number of Participants Who Died While in the Study

   Time frame: Study enrollment up to approximately 10 years

Baseline characteristics

2 further baseline measures are reported on the registry.

Publications

• 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. PubMed 25233155 ↗
• 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. PubMed 24122237 ↗
• 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. PubMed 23823978 ↗
• 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. PubMed 21543424 ↗