Ongoing Clinical Trials for Tertiary Adrenal Insufficiency
Currently, there is one ongoing clinical trial investigating treatment options for tertiary adrenal insufficiency. This trial focuses on patients with Giant Cell Arteritis or Polymyalgia Rheumatica who experience symptoms of adrenal insufficiency after stopping long-term glucocorticoid treatment.
Clinical trial locations
Study on Hydrocortisone and Placebo for Patients with Giant Cell Arteritis or Polymyalgia Rheumatica Experiencing Adrenal Insufficiency Symptoms
This clinical trial is examining the effectiveness of hydrocortisone in managing symptoms in patients who have Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR). Both of these conditions cause inflammation in the body, leading to pain and stiffness. The study specifically targets patients who have recently stopped taking glucocorticoid medications such as prednisolone and are experiencing symptoms that may indicate their adrenal glands are not producing enough hormones.
Main inclusion criteria:
- Patients must be 50 years of age or older
- Must have a confirmed diagnosis of polymyalgia rheumatica or giant cell arteritis
- Must be in glucocorticoid-free remission for more than 2 weeks but less than 12 weeks, meaning symptoms are not currently active after stopping glucocorticoids
- Must have received prednisolone treatment for at least 12 weeks previously
- Both men and women can participate
Main exclusion criteria:
- Patients who already have a diagnosis of tertiary adrenal insufficiency cannot participate in this trial
Focus and goal of the trial:
The primary goal of this 16-week study is to compare the effects of hydrocortisone against a placebo in managing symptoms of adrenal insufficiency that can occur after stopping glucocorticoid treatment. The trial is double-blinded, which means neither the participants nor the researchers know who is receiving the actual medication or the placebo. This design helps ensure that the results are unbiased and reliable.
Throughout the study, participants will be closely monitored for various symptoms and health indicators including fatigue levels, blood pressure, muscle strength, and bone health. Symptoms of adrenal insufficiency will be tracked using a specialized questionnaire called the AddiQoL-30. At the end of the 16-week period, researchers will conduct comprehensive assessments including metabolic and cardiovascular risk factors, body composition, and the body’s natural cortisol production.
Investigational drug:
The trial is testing hydrocortisone, a type of steroid medication that mimics the action of cortisol, a natural hormone produced by the adrenal glands. Hydrocortisone helps regulate inflammation and immune responses in the body. It is administered orally in tablet form throughout the study period. The medication works by replacing the hormones that the adrenal glands may not be producing in sufficient quantities after long-term glucocorticoid use has suppressed the body’s natural hormone production system.
Summary
Currently, only one clinical trial is actively investigating treatment approaches for tertiary adrenal insufficiency. This trial is being conducted in Denmark and focuses on a specific patient population: those with Giant Cell Arteritis or Polymyalgia Rheumatica who have recently discontinued glucocorticoid therapy. The research addresses an important clinical need, as many patients experience challenging symptoms when stopping long-term steroid treatment due to suppression of their natural hormone production.
The trial’s approach of comparing hydrocortisone to placebo in a double-blinded setting will provide valuable evidence-based guidance for healthcare providers managing patients transitioning off glucocorticoid treatment. The comprehensive monitoring of symptoms, quality of life, and various health indicators throughout the 16-week study period aims to help improve patient care and quality of life for those affected by this condition.
