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CompletedNCT01799408Updated Feb 26, 2013

Intra-articular Betamethasone and the Hypothalamic-pituitary-adrenal Axis

An observational study in Adrenal Suppression, sponsored by The Nazareth Hospital, Israel. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-26.

Sponsored by The Nazareth Hospital, Israel · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

Consecutive patients attending the rheumatology or orthopedic clinic with osteoarthritic knee pain, not responding satisfactorily to medical or physical therapy were allocated to group-1 after consent and given IACI of 6 mg of betamethasone acetate/betamethasone sodium phosphate. Following completion of this part, consecutive age- and sex-matched patients were allocated to group-2 and given intra-articular injection of 60 mg of sodium hyaluronate. Just prior to the knee injection and 1, 2, 3, 4 and 8 weeks later, patients had 1 µg adrenocorticotropin hormone (ACTH) stimulation test. Secondary adrenal insufficiency (SAI) was defined as levels of less than 18 ng/ml or a rise of \< than 7 ng/ml of serum cortisol, 30 minutes following the ACTH stimulation test.

02

Conditions studied

  • Adrenal Suppression
03

In context

Lead sponsor

The Nazareth Hospital, Israel is the lead sponsor of 6 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Osteoarthritis of the knee

Exclusion criteria

Exclusion Criteria:

  • Had steroids in the last 3 months. Allergic to steroids
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • betamethasone

    Patients who had intra-articular injection of betamethasone

  • Hyaluronic acid

    Patients who had intra-articular injection of hyaluronic acid

06

What researchers measure

Primary outcomes

  1. Adrenal Suppression

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

    Time frame: 2 months

Secondary outcomes

  1. favorable clinical response

    Time frame: 2 months

  2. Favorable clinical response

    Improvement of knee pain by more than 30 points according to visual analogue scale

    Time frame: 2 months following the steroid injection

Other outcomes

  1. Nadir serum cortisol level

    Time frame: 2 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01799408
Lead sponsor
The Nazareth Hospital, Israel
Responsible party
George Habib (Head rheunatology clinic, The Nazareth Hospital, Israel) — Principal investigator
First posted
Feb 26, 2013
Start date
Oct 2012
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Feb 26, 2013

Study contacts

George Habib, M.D.
principal investigator · Nazareth Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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