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Teriparatide for Fracture Repair in Humans

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Age-Related; Humeral Fractures

Intervention: Teriparatide (Drug); Placebo (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Christian Muschitz, M.D., Principal Investigator, Affiliation: Medical University Vienna, St. Vincent Hospital Vienna, Austria

Overall contact:
Christian Muschitz, M.D., Phone: +43159988, Ext: 2119, Email: christian.muschitz@bhs.at

Summary

This study will test the hypothesis that daily subcuaneous administration of 20g 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Identification of bone and callus patterns in the CT data at the fracture site

Secondary outcome: Finite Element Analysis (FEA) of QCT (quantitative computed tomography) data

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

Eligibility

Minimum age: 60 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Christian Muschitz, M.D., Phone: +43159988, Ext: 2119, Email: christian.muschitz@bhs.at

Medical University Vienna; St. Vincent Hospital, Vienna 1060, Austria; Not yet recruiting
Christian Muschitz, M.D., Phone: +43159988, Ext: 2119, Email: christian.muschitz@bhs.at
Roland Kocijan, M.D., Phone: +43159988, Email: roland.kocijan@bhs.at
Christian Muschitz, M.D., Principal Investigator
Heinrich Resch, M.D., Sub-Investigator
Roland Kocijan, M.D., Sub-Investigator
Wolfgang Schima, M.D., MSc, Sub-Investigator
Fritz Lomoschitz, M.D., Sub-Investigator
Judith Haschka, M.D., Sub-Investigator
Additional Information

Homepage of Research Team

Related publications:

Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946. Erratum in: Acta Orthop. 2010 Oct;81(5):647.

Starting date: June 2014
Last updated: March 17, 2014

Page last updated: August 20, 2015

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