Status:
COMPLETED
Treatment With PTH After Sternotomy in Cardiac Surgery Patients
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Takeda
Aarhus University Hospital
Conditions:
Disruption or Dehiscence of Closure of Sternum or Sternotomy
Eligibility:
MALE
50+ years
Phase:
PHASE3
Brief Summary
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.
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01466829
Start Date
October 1 2012
End Date
March 1 2014
Last Update
June 2 2014
Active Locations (1)
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1
Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby
Aarhus N, Denmark, 8200