Bone IngrowthEarly Phase 1NCT00585156
The Effects of Celecoxib on Bone Ingrowth
A Early Phase 1 study testing Celecoxib in people with Bone Ingrowth and Pain, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief. Read more about this study
- Who is it for?
- Ages 18 to 95 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Ingrowth, Pain
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2008
- Phase
- Early 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 18 to 95 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male VA bilateral TKA patients 18 years or older with primary OA diagnosis
Who cannot join
- Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline, Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs.
- Patients who have had CABG.
- Patients with a history of peptic ulcer disease, duodenal ulcers.
- Female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veteran Affairs (VA) Medical Center
Salt Lake City, Utah, 84148
About this study
Official title: The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans
The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.
- Conditions
- Bone Ingrowth, Pain
- Being tested
- Celecoxib
- Keywords
- Celebrex, Bone Ingrowth, Pain relief
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.
| Study group | Role | What they receive |
|---|---|---|
| Arm #1 | Experimental | Celebrex treatment group Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Ingrowth
Measured: 12 weeks
Secondary outcomes (1)
Pain Score
Measured: 10 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: New clinical finding with Celebrex and cardiac concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone IngrowthStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Roy Bloebaum, Ph.D., Principal investigator, Research Professor, Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585156
- Sponsor's protocol ID
- IIR#2005-0300
- Other IDs
- IIR#2005-0300
- Status last verified
- Mar 2016
- First submitted
- 26 Dec 2007
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hofmann AA, Bloebaum RD, Rubman MH, Bachus KN, Plaster RL. Microscopic analysis of autograft bone applied at the interface of porous-coated devices in human cancellous bone. Int Orthop. 1992;16(4):349-58. doi: 10.1007/BF00189618.
PubMed 1473888Hofmann AA, Bloebaum RD, Koller KE, Lahav A. Does celecoxib have an adverse effect on bone remodeling and ingrowth in humans? Clin Orthop Relat Res. 2006 Nov;452:200-4. doi: 10.1097/01.blo.0000238838.18799.61.
PubMed 17016230
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans
- ClinicalTrials.gov ID
- NCT00585156
- Acronym / sponsor ID
- IIR#2005-0300
- Conditions
- Bone Ingrowth, Pain
- Keywords
- Celebrex, Bone Ingrowth, Pain relief
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New clinical finding with Celebrex and cardiac concerns.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 3 Jan 2008 (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 purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm #1 | Experimental | Drug: CelecoxibCelebrex treatment group |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male VA bilateral TKA patients 18 years or older with primary OA diagnosis
Key exclusion criteria (4 listed)
- Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline, Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs.
- Patients who have had CABG.
- Patients with a history of peptic ulcer disease, duodenal ulcers.
- Female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.
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 |
|---|---|---|
| CelecoxibAlso: CelebrexTwelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period. | Drug | Arm #1 |
Primary outcome
Bone Ingrowth
Time frame: 12 weeks
1 secondary outcome
Pain Score
Time frame: 10 days postoperative
Results and safety
The study was stopped early (reason given: New clinical finding with Celebrex and cardiac concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Background: PubMed 1473888Hofmann AA, Bloebaum RD, Rubman MH, Bachus KN, Plaster RL. Microscopic analysis of autograft bone applied at the interface of porous-coated devices in human cancellous bone. Int Orthop. 1992;16(4):349-58. doi: 10.1007/BF00189618.
- Background: PubMed 17016230Hofmann AA, Bloebaum RD, Koller KE, Lahav A. Does celecoxib have an adverse effect on bone remodeling and ingrowth in humans? Clin Orthop Relat Res. 2006 Nov;452:200-4. doi: 10.1097/01.blo.0000238838.18799.61.
Related trials for Bone Ingrowth
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Cruciate Ligament Reconstruction
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.
Roy Bloebaum, Ph.D. principal investigator
Research Professor, Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Celecoxib in people with Bone Ingrowth and Pain, run by University of Utah at 1 site 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Mar 2016. 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: New clinical finding with Celebrex and cardiac concerns.). Results are not available in the source record.
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?
Bone Ingrowth (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00585156, which also lists 2 linked publications.
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 14 Mar 2016.