Adrenal SuppressionNCT01799408
Intra-articular Betamethasone and the Hypothalamic-pituitary-adrenal Axis
An observational study of Adrenal Suppression, run by The Nazareth Hospital, Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Suppression
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoarthritis of the knee and had not been onsteroids for at least 3 months
Who may be able to join
- Osteoarthritis of the knee
Who cannot join
- Had steroids in the last 3 months. Allergic to steroids
About this study
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
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.
- Conditions
- Adrenal Suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| betamethasone | Patients who had intra-articular injection of betamethasone | |
| Hyaluronic acid | Patients who had intra-articular injection of hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenal Suppression
Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress
Measured: 2 months
Secondary outcomes (2)
favorable clinical response
Measured: 2 months
Favorable clinical response
Improvement of knee pain by more than 30 points according to visual analogue scale
Measured: 2 months following the steroid injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal SuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Nazareth Hospital, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Habib, The Nazareth Hospital, Israel
- Investigators
- George Habib, M.D., Principal investigator, Nazareth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799408
- Sponsor's protocol ID
- HPA-2012
- Status last verified
- Feb 2013
- First submitted
- 21 Feb 2013
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01799408
- Acronym / sponsor ID
- HPA-2012
- Conditions
- Adrenal Suppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Nazareth Hospital, IsraelUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| betamethasone | – | –Patients who had intra-articular injection of betamethasone |
| Hyaluronic acid | – | –Patients who had intra-articular injection of hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarthritis of the knee and had not been onsteroids for at least 3 months
Key inclusion criteria (1 listed)
- Osteoarthritis of the knee
Key exclusion criteria (1 listed)
- Had steroids in the last 3 months. Allergic to steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adrenal Suppression
Time frame: 2 months
Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress
2 secondary outcomes
favorable clinical response
Time frame: 2 months
Favorable clinical response
Time frame: 2 months following the steroid injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
Related trials for Adrenal Suppression
RecruitingObservational study
A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children
Adrenal Insufficiency, Leukemia, Lymphoblastic, Acute, Pediatric
Not yet recruitingPhase 4
Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
Secondary Adrenal Insufficiency, Hypotension
RecruitingPhase 2
NeSST2: The Development of a Noninvasive Short Synacthen Test
Adrenal Suppression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Habib, M.D. principal investigator
Nazareth Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Suppression, run by The Nazareth Hospital, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adrenal Suppression (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2013.