- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01466829
Treatment With PTH After Sternotomy in Cardiac Surgery Patients (PAATH)
Clinical Effects of Parathyroid Hormone as Adjuvant Therapy for Bone Healing After Sternotomy.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Aarhus N, Denmark, 8200
- Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Control patients treated with placebo.
|
Placebo; saline injection.
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Active Comparator: Intervention
Daily injection with Parathyroid hormone
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100 microgram daily. S.c
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Computer Tomography
Time Frame: 6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)
|
Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.
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6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaires
Time Frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
|
Change of quality of life at different time frames compared with baseline.
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Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
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Journal parameters
Time Frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
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Admission time, blood tests, cross-clamp time, bypass time, time of mechanical ventilation, duration of surgery, pacingwires, type of operation, treatment with bisphosphonates, treatment with steroids, COLD, use of analgetics.
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Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Per Nielsen, MD, Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/386
- 2011-004465-32 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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