Intra-articular Betamethasone and the Hypothalamic-pituit... | NCT01799408

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

NCT01799408

Sponsor

The Nazareth Hospital, Israel

Status

Completed

Last Update Posted

Feb 26, 2013Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Adrenal Suppression

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Feb 21, 2013

First Submission Date that Met QC Criteria

Feb 23, 2013

First Posted Date

Feb 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2013

Last Update Posted Date

Feb 26, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

George Habib, Head rheunatology clinic, The Nazareth Hospital, IsraelPrincipal Investigator

Lead Sponsor

The Nazareth Hospital, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
betamethasone		Patients who had intra-articular injection of betamethasone
Hyaluronic acid		Patients who had intra-articular injection of hyaluronic acid

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adrenal Suppression	Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress	2 months

Secondary Outcomes

Measure	Description	Time Frame
favorable clinical response		2 months
Favorable clinical response	Improvement of knee pain by more than 30 points according to visual analogue scale	2 months following the steroid injection

Other Outcomes

Measure	Description	Time Frame
Nadir serum cortisol level		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Osteoarthritis of the knee

Exclusion Criteria:

Had steroids in the last 3 months. Allergic to steroids

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample