Disruption or Dehiscence of Closure of Sternum or SternotomyPhase 3PAATHNCT01466829
Treatment With PTH After Sternotomy in Cardiac Surgery Patients
A Phase 3 study testing Parathyroid hormone in people with Disruption or Dehiscence of Closure of Sternum or Sternotomy, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Disruption or Dehiscence of Closure of Sternum or Sternotomy
- What is being tested?
- Parathyroid hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- No known risk of osteosarcoma.
- Ability to understand and cooperate with the planned examinations.
- Ability to speak and understand Danish.
Who cannot join
- 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
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- Major medical or social problems that will be likely to preclude participation
- Severely impaired lever function
- Unknown raised levels of bone specific alkaline phosphatase.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Cardiothoracic & Vascular Surgery, AArhus University Hospital, Skejby
Aarhus N, 8200
About this study
Official title: Clinical Effects of Parathyroid Hormone as Adjuvant Therapy for Bone Healing After Sternotomy.
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.
Read the 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.
- Being tested
- Parathyroid hormone, Placebo
- Keywords
- sternotomy, parathyroid hormone, bone healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid hormoneDrug
Also called Preotact®
100 microgram daily. S.c
PlaceboDrug
Placebo; saline injection.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control patients treated with placebo. Receives: Drug: Placebo |
| Intervention | Active comparator | Daily injection with Parathyroid hormone Receives: Drug: Parathyroid hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computer Tomography
Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.
Measured: 6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)
Secondary outcomes (2)
Questionnaires
Change of quality of life at different time frames compared with baseline.
Measured: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Journal parameters
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.
Measured: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruption or Dehiscence of Closure of Sternum or SternotomyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Per Nielsen, MD, Principal investigator, Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466829
- Sponsor's protocol ID
- 2011/386
- Other IDs
- 2011-004465-32
- Acronym
- PAATH
- Status last verified
- Aug 2013
- First submitted
- 24 Oct 2011
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Parathyroid Hormone as Adjuvant Therapy for Bone Healing After Sternotomy.
- ClinicalTrials.gov ID
- NCT01466829
- Acronym / sponsor ID
- PAATH / 2011/386
- Keywords
- sternotomy, parathyroid hormone, bone healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Takeda, Aarhus University Hospital
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboControl patients treated with placebo. |
| Intervention | Active comparator | Drug: Parathyroid hormoneDaily injection with Parathyroid hormone |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parathyroid hormoneAlso: Preotact®100 microgram daily. S.c | Drug | Intervention |
| PlaceboPlacebo; saline injection. | Drug | Control |
Primary outcome
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.
2 secondary outcomes
Questionnaires
Time frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Journal parameters
Time frame: Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Nielsen, MD principal investigator
Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Parathyroid hormone in people with Disruption or Dehiscence of Closure of Sternum or Sternotomy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computer Tomography (time frame: 6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.