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

Adrenal Suppression Clinical Trial

Official title:

The Effect of Intra-articular Injection of Betamethasone Acetate/Betamethasone Sodium Phosphate at the Knee Joint on the Hypothalamic-pituitary-adrenal Axis: a Case Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799408
• Other study ID #: HPA-2012
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: February 23, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: The Nazareth Hospital, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Osteoarthritis of the knee

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adrenal Suppression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Nazareth Hospital, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nadir serum cortisol level		2 months	No
Primary	Adrenal Suppression	Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress	2 months	No
Secondary	favorable clinical response		2 months	No
Secondary	Favorable clinical response	Improvement of knee pain by more than 30 points according to visual analogue scale	2 months following the steroid injection	No