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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Takeda Nycomed
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01466829
First received: October 24, 2011
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Disruption or Dehiscence of Closure of Sternum or Sternotomy
Drug: Parathyroid hormone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Effects of Parathyroid Hormone as Adjuvant Therapy for Bone Healing After Sternotomy.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Computer Tomography [ Time Frame: 6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks) ] [ Designated as safety issue: Yes ]
    Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.


Secondary Outcome Measures:
  • Questionnaires [ Time Frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks) ] [ Designated as safety issue: No ]
    Change of quality of life at different time frames compared with baseline.

  • Journal parameters [ Time Frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 26
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Control patients treated with placebo.
Drug: Placebo
Placebo; saline injection.
Other Name: Placebo
Active Comparator: Intervention
Daily injection with Parathyroid hormone
Drug: Parathyroid hormone
100 microgram daily. S.c
Other Name: Preotact®

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466829

Locations
Denmark
Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Takeda Nycomed
Aarhus University Hospital
Investigators
Principal Investigator: Per Nielsen, MD Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01466829     History of Changes
Other Study ID Numbers: 2011/386, 2011-004465-32
Study First Received: October 24, 2011
Last Updated: August 15, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
sternotomy
parathyroid hormone
bone healing

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014