Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
Study NCT ID:
NCT02091492
Status:
WITHDRAWN
Last Update Posted:
2015-09-17
First Post:
2014-03-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Teriparatide for Fracture Repair in Humans
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Teriparatide for Fracture Repair in Humans: A Prospective, Randomized, Double-blind Placebo-controlled Pilot Study in Female and Male Patients With Proximal Humerus Fracture: The TERAFRAP Study
Status:
WITHDRAWN
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TERAFRAP
Brief Summary:
This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.
Detailed Description:
1. Primary objective:
The primary objective is the quantitative assessment of fracture healing (2-segment proximal humerus frafcture) in the treatment (daily teriapratide 20µg subcitaneous injection for 12 weeks) and in the placebo group (daily placebo subcutaneous injection for 12 weeks) based on computed tomography data (QCT; baseline and after 12 weeks) and computational analysis of the three simensional bone structure in the fracture zone. Bone structure will be assessed by means of quantized bone texture characteristics (callus formation, improvement of trabecualar and cortical bone structure) in the vicinity of the fracture.
2. Secondary objectives:
2.1.Detection and quantification of changes in bone mineralization at the fracture site between a baseline QCT scan and a follow-up QCT scan (planned interval: 12 weeks) using 3-D texture-based cluster analysis between the two groups.
2.2 Evaluation of bone strength variation in the proximal humerus and the measurement of biomechanical properties (stiffness, strength, damage) based on the Finite Element (FE) technique between the two groups.
2.3.Baseline characterization of osteoporotic study population: age, sex, concomitant diseases, serum markers of bone formation and bone resorption, serum colecalciferol levels.
2.4.Evaluation of fasting bone formation and resorption markers at baseline and after 3 months follow up between the TPDT and the placebo group.
2.5.Assessment of quality of life improvement for TPTD and placebo groups with EQ-5D questionnaire (measurement every 4 weeks).
2.6.Assessment of pain reduction in TPTD and placebo groups by visual analog scale (VAS) during 12 weeks (measurement every 4 weeks).
2.7.Assessment of functional testing after 3 and 6 months (functional testing score (ASES Score: "American Shoulder and Elbow Surgeon Score")
2.8.Dual energy x-ray absorptiometry (DXA) bone mineral density (BMD) measurements of lumbar spine and early changes of geometrical hip parameters (cross sectional area - CSA, cross sectional moment of inertia - CSMI), hip BMD(femoral neck and total hip area) and total body (lean mass, fat mass, total body BMD)
2.9. Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The primary objective is the quantitative assessment of fracture healing (2-segment proximal humerus frafcture) in the treatment (daily teriapratide 20µg subcitaneous injection for 12 weeks) and in the placebo group (daily placebo subcutaneous injection for 12 weeks) based on computed tomography data (QCT; baseline and after 12 weeks) and computational analysis of the three simensional bone structure in the fracture zone. Bone structure will be assessed by means of quantized bone texture characteristics (callus formation, improvement of trabecualar and cortical bone structure) in the vicinity of the fracture.
2. Secondary objectives:
2.1.Detection and quantification of changes in bone mineralization at the fracture site between a baseline QCT scan and a follow-up QCT scan (planned interval: 12 weeks) using 3-D texture-based cluster analysis between the two groups.
2.2 Evaluation of bone strength variation in the proximal humerus and the measurement of biomechanical properties (stiffness, strength, damage) based on the Finite Element (FE) technique between the two groups.
2.3.Baseline characterization of osteoporotic study population: age, sex, concomitant diseases, serum markers of bone formation and bone resorption, serum colecalciferol levels.
2.4.Evaluation of fasting bone formation and resorption markers at baseline and after 3 months follow up between the TPDT and the placebo group.
2.5.Assessment of quality of life improvement for TPTD and placebo groups with EQ-5D questionnaire (measurement every 4 weeks).
2.6.Assessment of pain reduction in TPTD and placebo groups by visual analog scale (VAS) during 12 weeks (measurement every 4 weeks).
2.7.Assessment of functional testing after 3 and 6 months (functional testing score (ASES Score: "American Shoulder and Elbow Surgeon Score")
2.8.Dual energy x-ray absorptiometry (DXA) bone mineral density (BMD) measurements of lumbar spine and early changes of geometrical hip parameters (cross sectional area - CSA, cross sectional moment of inertia - CSMI), hip BMD(femoral neck and total hip area) and total body (lean mass, fat mass, total body BMD)
2.9. Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| # 317.276.2000 | OTHER_GRANT | Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA | View |