Can treatment with parathyroid hormone enhance bone healing and quality of newly formed bone after splitting of the chest bone in cardiac surgery patients?

Phase 1

• Conditions: Sternotomy; MedDRA version: 14.1Level: LLTClassification code 10051332Term: Surgical procedureSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-004465-32-DK
• Lead Sponsor: Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Men 50 years of age or more
Full sternotomy
Not in chronic, systemic corticosteroid treatment.
No Plavix treatment 5 days prior to surgery
No known bone metabolic diseases.
Normal serum levels of Vitamin D, Calcium, PTH, 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Re-operation
Use of bonewax 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 liver function
Unknown raised levels of bone specific alkaline phosphatase

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified