Overview
Treatment With PTH After Sternotomy in Cardiac Surgery Patients
Status:
Completed
Completed
Trial end date:
2014-03-01
2014-03-01
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of AarhusCollaborators:
Aarhus University Hospital
Takeda
Takeda PharmaTreatments:
Hormones
Parathyroid Hormone
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.