Treatment With PTH After Sternotomy in Cardiac Surgery Patients

NCT ID: NCT01466829

Last Updated: 2014-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-03-31

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 department of Cardiothoracic & Vascular Surgery at Skejby Hospital alone, over 1000 sternotomies are performed each year. When closing the sternum, the normal procedure is to use steel wires to hold the two sternal halves together. The patient receives no additional medical treatment to improve bone healing. Following surgery, sufficient healing of the sternum is important to prevent complications and to ensure a high level of life-quality for the patient. It has been shown that forces, equally to those produced during a normal cough, can displace the wire-fixated sternum by more than 2 mm. Reduced stability of the sternum has a negative impact on the healing process and increases the risk of infections. Another known complication to sternotomy is pseudoarthrosis (nonunion), which is caused by insufficient healing of the sternum and may result in instability, chronic pain and reduced quality of life. These complications result in prolonged admittance time, increased mortality and morbidity and from a financial point of view, increased treatment-costs for each patient.

Parathyroid hormone (PTH) is a well known anabolic drug and has been used to treat osteoporosis in post-menopausal women with great effect. A continuous high level of PTH decreases bone density and induces hypercalcemia, but if given once daily PTH has an anabolic effect on bone. It is being investigated if it is possible to use PTH in the treatment of other conditions, for example in the treatment of bone fractures.

Several studies, both clinical and experimental, show that PTH advances healing time and increases the quality of newly formed bone. It has also been shown to enable healing in sternal nonunion in one case-study. A recent human study of 102 osteoporotic women, with fractures of their radial bone, showed that daily injection with 20µg of the PTH-analog PTH1-34 (Teriparatide) reduces the fracture healing time. The effect of PTH on bone healing in sternum after a sternotomy has not previously been investigated.

In this study, we aim to investigate the effect of PTH on sternal healing in a clinical setup.

Conditions

Disruption or Dehiscence of Closure of Sternum or Sternotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Control patients treated with placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo; saline injection.

Intervention

Daily injection with Parathyroid hormone

Group Type: ACTIVE_COMPARATOR

Parathyroid hormone

Intervention Type: DRUG

100 microgram daily. S.c

Interventions

Parathyroid hormone

100 microgram daily. S.c

Intervention Type: DRUG

Placebo

Placebo; saline injection.

Intervention Type: DRUG

Other Intervention Names

Preotact®

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby

Locations

Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby

Aarhus N, , Denmark

Countries

Denmark

Other Identifiers

2011-004465-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2011/386

Identifier Type: -

Identifier Source: org_study_id