Teriparatide for Fracture Repair in Humans (TERAFRAP)

September 16, 2015 updated by: Dr. Christian Muschitz, Medical University of Vienna

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1060
        • Medical University Vienna; St. Vincent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • recent proximal 2-segment humerus fracture (0-8 days post fracture)
  • no surgical treatment at fractured site
  • signed informed consent
  • postmenopausal female and male patients aged 60 - 85 years
  • established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip

Exclusion Criteria:

  • Hypersensitivity to the active substance or to any of the excipients.
  • Pre-existing hypercalcemia
  • Severe renal impairment (eGFR< 35ml/min)
  • Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
  • Unexplained elevations of alkaline phosphatase
  • Prior external beam or implant radiation therapy to the skeleton
  • Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
  • any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody, SERMs)
  • any prior strontium ranelate therapy
  • any prior TPTD of PTH 1-84 therapy
  • malignancies ≤ 5 years except basalioma
  • hypo-/hypercalcemia
  • baseline 25-OH vitamin D3 level ≤10 ng/ml
  • prosthesis at fractured and contralateral humerus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Teriparatide
Teriparatide 20µg daily subcutaneous injection for 12 weeks after proximal humerus fracture
Drug: Teriparatide
Teriparatide 20 µg sc (subcutaneous injection) each day for 12 weeks
Other Names:
  • Forteo
PLACEBO_COMPARATOR: Placebo-Teriparatide
Placebo-Teriparatide 20 µg daily subcutaneous injection for 12 weeks after proximal humerus fracture
Drug: Placebo
Placebo teriparatide sc (subcutaneous injection) each day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of bone and callus patterns in the CT data at the fracture site
Time Frame: 12 weeks
As a basis for change quantification, we will identify 3D micro-architecture patterns that occur in the study CT data. These patterns are either learned based on annotated examples, manual segmentation of specific regions in a number of reference examples, or in a data-driven fashion (computer based identification of pattern classes).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finite Element Analysis (FEA) of QCT (quantitative computed tomography) data
Time Frame: 12 weeks
The FEA Method will be a second diagnostic tool in order to evaluate the change in bone strength in the proximal humerus during treatment.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracking geometry during bone healing
Time Frame: 12 weeks
The extent of bridging and callus formation will be quantified, based on the voxel-wise comparison of follow-up data. The accumulated density difference between baseline and follow-up over a region of interest serves as parameter.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Christian Muschitz, M.D., Medical University Vienna, St. Vincent Hospital Vienna, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

September 1, 2015

Study Completion (ANTICIPATED)

September 1, 2015

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (ESTIMATE)

March 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vinforce_006
  • # 317.276.2000 (OTHER_GRANT: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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