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Trial · Interventional

CompletedPhase 3Registry data

Treatment With PTH After Sternotomy in Cardiac Surgery Patients

Short name PAATH

NCTNCT01466829 (opens ClinicalTrials.gov in a new tab)Other id2011/386Other id2011-004465-32
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Overview

Status
Completed
Phase
Phase 3
Enrollment
20 participants (actual)
Sponsor
University of Aarhus · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Oct 2012
Primary completion
Mar 2014
Completion
Mar 2014
First posted
8 Nov 2011 (estimated)
Last update posted
2 Jun 2014 (estimated)
Conditions
Disruption or Dehiscence of Closure of Sternum or Sternotomy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 3

    PAATH

    NCT01466829

    Oct 2012 to Mar 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Parathyroid hormoneDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Control

    Control patients treated with placebo.

  • Active comparator

    Intervention

    Daily injection with Parathyroid hormone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Computer Tomography

    Time frame · 6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)

    Registry description

    Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.

Secondary outcomes(2)

  1. Questionnaires

    Time frame · Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)

    Registry description

    Change of quality of life at different time frames compared with baseline.

  2. Journal parameters

    Time frame · Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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