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CompletedNCT01133613Updated Feb 1, 2012

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 interventional study of Bone morphogenetic protein 7 in Osteoarthritis of the Knee, sponsored by Stryker Biotech. Completed at 2 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-02-01.

Sponsored by Stryker Biotech · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis of the Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 51 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Stryker Biotech is the lead sponsor of 3 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria

  • 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
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Cohort 1

    0.03 mg/ml BMP-7 or placebo via intraarticular knee injection

    Drug: Bone morphogenetic protein 7

  • Experimental
    Cohort 2

    0.1 mg/ml BMP-7 or placebo via intraarticular knee injection

    Drug: Bone morphogenetic protein 7

  • Experimental
    Cohort 3

    0.3 mg/ml BMP-7 or placebo via intraarticular knee injection

    Drug: Bone morphogenetic protein 7

Interventions

  • DrugBone morphogenetic protein 7

    Single intraarticular injection of BMP-7 or placebo on Day 1

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. WOMAC pain and function

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24

  2. Patient and physician global VAS

    Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

  3. Quality of life measurement (SF-36) and pain medication use

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24

07

Study locations

2 sites
  • Florida Medical Research Institute
    Gainesville, Florida 32607, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01133613
Lead sponsor
Stryker Biotech
Responsible party
Sponsor
First posted
May 31, 2010
Start date
May 2010
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Feb 1, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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