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TerminatedNCT00585156Updated Mar 14, 2016

The Effects of Celecoxib on Bone Ingrowth

An Early Phase 1 interventional study of Celecoxib in Bone Ingrowth and Pain, sponsored by University of Utah. Terminated at 1 site in United States. Open to male participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-14.

Sponsored by University of Utah · Early Phase 1, Interventional, and Basic science

Why this study was terminated
New clinical finding with Celebrex and cardiac concerns.
Phase
Early Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 95 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Bone Ingrowth
  • Pain

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Keywords

  • Celebrex, Bone Ingrowth, Pain relief
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 9 is below the median of 70 across 2,101 interventional studies indexed under Pain.

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Lead sponsor

University of Utah is the lead sponsor of 991 studies on the registry; 177 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male VA bilateral TKA patients 18 years or older with primary OA diagnosis

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Arm #1

    Celebrex treatment group

    Drug: Celecoxib

Interventions

  • DrugCelecoxib

    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.

    Also known as: Celebrex

06

What researchers measure

Primary outcomes

  1. Bone Ingrowth

    Time frame: 12 weeks

Secondary outcomes

  1. Pain Score

    Time frame: 10 days postoperative

07

Study locations

1 site
  • Veteran Affairs (VA) Medical Center
    Salt Lake City, Utah 84148, United States
08

References and documents

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 1473888 ↗
  • Hofmann 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2008, a primary completion of Sep 2008 and a completion of Sep 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2007
First posted
Jan 3, 2008
Start
Jun 2008
Primary completionActual
Sep 2008
CompletionActual
Sep 2008
Last update
Mar 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00585156
Lead sponsor
University of Utah
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Jan 3, 2008
Start date
Jun 2008
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Mar 14, 2016

Study contacts

Roy Bloebaum, Ph.D.
principal investigator · Research Professor, Orthopedic Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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