Bone Degenerative ChangesPhase 1NCT01690260
Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment
A Phase 1 study testing Bone Morphogenetic Protein 2 and Autologous bone graft in people with Bone Degenerative Changes and Osteoarthritis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local application of BMP results in an increase of osseous tissue regardless of the location of the growth factor. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Bone Degenerative Changes, Osteoarthritis, Degenerative Disorder of Bone
- What is being tested?
- Bone Morphogenetic Protein 2 and Autologous bone graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2004to 2 Oct 2017
- Phase
- Phase 1
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalised for autologous bone graft based on Ilizarow treatment.
- Age between 20 and 70 years.
Who cannot join
- Rheumatoid osteoarthritis
- Malignant disease
- Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea)
- Pregnancy
- Abuse of drugs and alcohol
- Need of long-term NSAID treatment
- Breastfeeding women
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Surgery Research Unit, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.
Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local application of BMP results in an increase of osseous tissue regardless of the location of the growth factor.
5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and improve clinical results when autologous bone graft is reduced or removed.
The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace autologous bone graft in order to stimulating ossification during transplantation of osseous tissue.
- Being tested
- Bone Morphogenetic Protein 2, Autologous bone graft
- Keywords
- Bone, Morphogenetic, Protein, Ilizarow, Autologous, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Morphogenetic Protein 2Drug
Also called No other names.
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
Autologous bone graftProcedure or surgery
Also called No other names.
Autologous bone graft in connection with bone docking operation.
| Study group | Role | What they receive |
|---|---|---|
| Bone Morphogenetic Protein 2 | Experimental | Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system. Receives: Drug: Bone Morphogenetic Protein 2; Procedure: Autologous bone graft |
| Autologous bone graft | Experimental | Condition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process. Receives: Drug: Bone Morphogenetic Protein 2; Procedure: Autologous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visible radiological signs of healing after 6 months.
Radiological signs of healing is a criteria for a successful result.
Failure of healing after 6 months and/or a need for stimulant bone healing intervention can result in:
- Dynamic measurement af immobilization
- Ultrasound stimulation
- Re-surgery with application of bone graft or bone replacement
Measured: An expected average of 6 months
Secondary outcomes (1)
Change in serologic bone markers
Blood tests will be analyzed 1,2,3,4,6,9 and 12 months after operation in order to registrating a change in serologic bone markers.
Measured: An expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2004
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Degenerative ChangesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Center for Clinical and Basic Research (CCBR A/S).
- Responsible party
- Sponsor
- Investigators
- Knud S. Christensen, MD, Principal investigator, Orthopaedic Surgery Research Unit, Aalborg University Hospital, DenmarkDavid Donnell, Advisor, Study chair, Medtronic Inc., WatfordHans H. Hoeck, MD, Ph.D., Study chair, Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690260
- Sponsor's protocol ID
- N-20040019
- Status last verified
- Oct 2017
- First submitted
- 12 Sep 2012
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.
- ClinicalTrials.gov ID
- NCT01690260
- Acronym / sponsor ID
- N-20040019
- Keywords
- Bone, Morphogenetic, Protein, Ilizarow, Autologous, Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Medtronic, Center for Clinical and Basic Research (CCBR A/S).
- Study start
- Sep 2004 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 21 Sep 2012 (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.
Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local application of BMP results in an increase of osseous tissue regardless of the location of the growth factor.
5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and improve clinical results when autologous bone graft is reduced or removed.
The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace autologous bone graft in order to stimulating ossification during transplantation of osseous tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Morphogenetic Protein 2 | Experimental | Drug: Bone Morphogenetic Protein 2, Procedure: Autologous bone graftCondition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system. |
| Autologous bone graft | Experimental | Drug: Bone Morphogenetic Protein 2, Procedure: Autologous bone graftCondition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalised for autologous bone graft based on Ilizarow treatment.
- Age between 20 and 70 years.
Key exclusion criteria (7 listed)
- Rheumatoid osteoarthritis
- Malignant disease
- Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea)
- Pregnancy
- Abuse of drugs and alcohol
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 |
|---|---|---|
| Bone Morphogenetic Protein 2Also: No other names.12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1. | Drug | Autologous bone graft, Bone Morphogenetic Protein 2 |
| Autologous bone graftAlso: No other names.Autologous bone graft in connection with bone docking operation. | Procedure or surgery | Autologous bone graft, Bone Morphogenetic Protein 2 |
Primary outcome
Visible radiological signs of healing after 6 months.
Time frame: An expected average of 6 months
Radiological signs of healing is a criteria for a successful result. Failure of healing after 6 months and/or a need for stimulant bone healing intervention can result in: * Dynamic measurement af immobilization * Ultrasound stimulation * Re-surgery with application of bone graft or bone replacement
1 secondary outcome
Change in serologic bone markers
Time frame: An expected average of 6 months
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 5 Oct 2017.
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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.
Knud S. Christensen, MD principal investigator
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
David Donnell, Advisor study chair
Medtronic Inc., Watford
Hans H. Hoeck, MD, Ph.D. study chair
Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bone Morphogenetic Protein 2 and Autologous bone graft in people with Bone Degenerative Changes and Osteoarthritis, run by Northern Orthopaedic Division, Denmark 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 2 inclusion and 7 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 5 Oct 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Visible radiological signs of healing after 6 months. (time frame: An expected average of 6 months). 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 5 Oct 2017.