NCT01799408

Brief Summary

To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients with osteoarthritis of the knee

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
Last Updated

February 26, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

February 21, 2013

Last Update Submit

February 23, 2013

Conditions

Adrenal Suppression

Outcome Measures

Primary Outcomes (1)

  • Adrenal Suppression

    Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress

    2 months

Secondary Outcomes (2)

  • favorable clinical response

    2 months

  • Favorable clinical response

    2 months following the steroid injection

Other Outcomes (1)

  • Nadir serum cortisol level

    2 months

Study Arms (2)

betamethasone

Patients who had intra-articular injection of betamethasone

Hyaluronic acid

Patients who had intra-articular injection of hyaluronic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with osteoarthritis of the knee and had not been onsteroids for at least 3 months

You may qualify if:

  • Osteoarthritis of the knee

You may not qualify if:

  • Had steroids in the last 3 months. Allergic to steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • George Habib, M.D.

    Nazareth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head rheunatology clinic

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 26, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 26, 2013

Record last verified: 2013-02