N/A
N=377
A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients
Growth Hormone Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01947894 ↗Enrolled (actual)
377
Serious AEs
19.3%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments — 11; 2; 4; 63 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non Interventional Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments |
11; 2; 4; 63; 8; 30 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
103; 17; 22; 57; 5; 10 | — |
| SECONDARY Number of Treatment Related Adverse Events |
8; 2; 0 | — |
| SECONDARY Number of Adverse Events Leading to Withdrawal of Genotropin Treatment |
14; 2; 1 | — |
| SECONDARY Number of Participants Who Discontinued Study Due to Adverse Events |
5; 1; 0 | — |
| SECONDARY Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5 |
83.8; 82.4; 86.9; 83.9; 86.4; 84.3 | — |
| SECONDARY Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5 |
0; -2.0; -2.3; -0.7; -1.6; 1.0 | — |
| SECONDARY Height of Participants at Baseline, Years 1, 2, 3, 4 and 5 |
171.7; 172.2; 171.7; 171.9; 174.0; 170.6 | — |
| SECONDARY Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5 |
0; -0.1; 0; 0; -0.1; 0 | — |
| SECONDARY Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5 |
28.3; 27.8; 29.6; 28.2; 28.3; 28.9 | — |
| SECONDARY Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5 |
0; -0.4; -0.9; -0.2; -0.5; 0.3 | — |
| SECONDARY Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5 |
132.3; 123.6; 120.3; 132.7; 127.4; 122.9 | — |
| SECONDARY Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5 |
1.0; -0.9; 3.4; 0.4; 6.1; 2.3 | — |
| SECONDARY Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5 |
69.3; 68.7; 69.7; 70.2; 70.7; 74.1 | — |
| SECONDARY Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5 |
1.4; -1.4; 4.7; 0.7; 1.8; 3.4 | — |
| SECONDARY Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4 |
48.78; 47.37; 58.62; 31.30; 5.26; 31.03 | — |
| SECONDARY Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5 |
32.93; 42.11; 18.39; 14.63; 23.68; 6.9 | — |
| SECONDARY Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4 |
2.03; 2.63; 1.15; 1.63; 1.15; 1.63 | — |
| SECONDARY Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up |
83.0; 69.0; 83.0; 92.3; 73.8; 88.6 | — |
Summary
The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment.
This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.
Eligibility Criteria
Inclusion Criteria
- Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;
- Newly diagnosed with GHD according to the current medical standard.
- Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.
- Transition patients diagnosed with CO-GHD before 2013.
- Prescribed Genotropin at the time of inclusion.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
- Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.
Data sourced from ClinicalTrials.gov (NCT01947894). 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.