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.