Osteoarthritis of the KneePhase 1NCT01133613
Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
A Phase 1 study testing Bone morphogenetic protein 7 in people with Osteoarthritis of the Knee, run by Stryker Biotech at 2 sites in United States.
Trial summary
The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Bone morphogenetic protein 7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Oct 2011
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
- >40 years
- Radiographic evidence of at least one osteophyte in either knee at screening
Who cannot join
- Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
- Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
- Received arthroscopic or open surgery to the index knee within 6 months of screening
- History of joint replacement surgery (index knee).
- Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
- Long acting hyaluronic acid injection of the index knee within 6 months of screening
Show all 9Show fewer
- History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
- History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
- Female subject with reproductive capability.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Florida Medical Research Institute
Gainesville, Florida, 32607
About this study
The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Bone morphogenetic protein 7
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone morphogenetic protein 7Drug
Single intraarticular injection of BMP-7 or placebo on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.03 mg/ml BMP-7 or placebo via intraarticular knee injection Receives: Drug: Bone morphogenetic protein 7 |
| Cohort 2 | Experimental | 0.1 mg/ml BMP-7 or placebo via intraarticular knee injection Receives: Drug: Bone morphogenetic protein 7 |
| Cohort 3 | Experimental | 0.3 mg/ml BMP-7 or placebo via intraarticular knee injection Receives: Drug: Bone morphogenetic protein 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
Measured: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
Secondary outcomes (3)
WOMAC pain and function
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Patient and physician global VAS
Measured: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
Quality of life measurement (SF-36) and pain medication use
Measured: Baseline, Week 4, Week 8, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133613
- Sponsor's protocol ID
- 09-OA-003
- Status last verified
- Jan 2012
- First submitted
- 27 May 2010
- Last updated
- 1 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
- ClinicalTrials.gov ID
- NCT01133613
- Acronym / sponsor ID
- 09-OA-003
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Stryker BiotechIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 31 May 2010 (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 objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Bone morphogenetic protein 70.03 mg/ml BMP-7 or placebo via intraarticular knee injection |
| Cohort 2 | Experimental | Drug: Bone morphogenetic protein 70.1 mg/ml BMP-7 or placebo via intraarticular knee injection |
| Cohort 3 | Experimental | Drug: Bone morphogenetic protein 70.3 mg/ml BMP-7 or placebo via intraarticular knee injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
- >40 years
- Radiographic evidence of at least one osteophyte in either knee at screening
Key exclusion criteria (9 listed)
- Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
- Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
- Received arthroscopic or open surgery to the index knee within 6 months of screening
- History of joint replacement surgery (index knee).
- Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
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 7Single intraarticular injection of BMP-7 or placebo on Day 1 | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
Time frame: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
3 secondary outcomes
WOMAC pain and function
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24
Patient and physician global VAS
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
Quality of life measurement (SF-36) and pain medication use
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24
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 1 Feb 2012.
Related trials for Osteoarthritis of the Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 7 in people with Osteoarthritis of the Knee, run by Stryker Biotech at 2 sites in United States.
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 3 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 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Safety (physical examination, vital signs, clinical laboratory measurements, adverse events) (time frame: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24). 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 1 Feb 2012.