Treatment With PTH After Sternotomy in Cardiac Surgery Patients (PAATH)

May 30, 2014 updated by: University of Aarhus

Clinical Effects of Parathyroid Hormone as Adjuvant Therapy for Bone Healing After Sternotomy.

The aims of this study is to compare healing time and quality of newly formed bone in cardiac surgery patients treated with PTH post-surgically and a control group treated with saline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart surgery is most commonly performed through a central division of the sternum, a sternotomy. This procedure provides full overview of the thoracic cavity and access to the organs within. At the department of Cardiothoracic & Vascular Surgery at Skejby Hospital alone, over 1000 sternotomies are performed each year. When closing the sternum, the normal procedure is to use steel wires to hold the two sternal halves together. The patient receives no additional medical treatment to improve bone healing. Following surgery, sufficient healing of the sternum is important to prevent complications and to ensure a high level of life-quality for the patient. It has been shown that forces, equally to those produced during a normal cough, can displace the wire-fixated sternum by more than 2 mm. Reduced stability of the sternum has a negative impact on the healing process and increases the risk of infections. Another known complication to sternotomy is pseudoarthrosis (nonunion), which is caused by insufficient healing of the sternum and may result in instability, chronic pain and reduced quality of life. These complications result in prolonged admittance time, increased mortality and morbidity and from a financial point of view, increased treatment-costs for each patient.

Parathyroid hormone (PTH) is a well known anabolic drug and has been used to treat osteoporosis in post-menopausal women with great effect. A continuous high level of PTH decreases bone density and induces hypercalcemia, but if given once daily PTH has an anabolic effect on bone. It is being investigated if it is possible to use PTH in the treatment of other conditions, for example in the treatment of bone fractures.

Several studies, both clinical and experimental, show that PTH advances healing time and increases the quality of newly formed bone. It has also been shown to enable healing in sternal nonunion in one case-study. A recent human study of 102 osteoporotic women, with fractures of their radial bone, showed that daily injection with 20µg of the PTH-analog PTH1-34 (Teriparatide) reduces the fracture healing time. The effect of PTH on bone healing in sternum after a sternotomy has not previously been investigated.

In this study, we aim to investigate the effect of PTH on sternal healing in a clinical setup.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Denmark
      • Aarhus N, Denmark, 8200
        • Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Full sternotomy
  • Not in chronic, systemic corticosteroid treatment.
  • No Plavix treatment 5 days prior to surgery
  • No known bone metabolic diseases.
  • Replete vitamin D status (plasma 25-hydroxyvitamin D >50 nmol/l)
  • Normal serum levels of Calcium, Phosphate, inorganic, alkaline phosphatase (within reference interval).
  • No known risk of osteosarcoma.
  • Ability to understand and cooperate with the planned examinations.
  • Ability to speak and understand Danish.

Exclusion Criteria:

  • Re-operation
  • Use of bone wax during surgery
  • Prior radiation therapy involving the skeleton
  • Severely impaired renal function.
  • Known allergic reactions to any of the compounds in the trial medication.
  • Current treatment with digoxin
  • Major medical or social problems that will be likely to preclude participation
  • Severely impaired lever function
  • Unknown raised levels of bone specific alkaline phosphatase.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Control patients treated with placebo.
Drug: Placebo
Placebo; saline injection.
Active Comparator: Intervention
Daily injection with Parathyroid hormone
Drug: Parathyroid hormone
100 microgram daily. S.c
Other Names:
  • Preotact®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computer Tomography
Time Frame: 6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)
Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.
6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaires
Time Frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Change of quality of life at different time frames compared with baseline.
Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Journal parameters
Time Frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Admission time, blood tests, cross-clamp time, bypass time, time of mechanical ventilation, duration of surgery, pacingwires, type of operation, treatment with bisphosphonates, treatment with steroids, COLD, use of analgetics.
Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Takeda
Aarhus University Hospital

Investigators

  • Principal Investigator: Per Nielsen, MD, Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby

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

October 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/386
  • 2011-004465-32 (EudraCT Number)

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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