Overview

Treatment With PTH After Sternotomy in Cardiac Surgery Patients

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Aarhus
Collaborators:
Aarhus University Hospital
Takeda
Takeda Pharma
Treatments:
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.