In short
There is currently 1 ongoing clinical trial investigating treatment options for Albright's disease in adults. This trial is testing the medication Denosumab to help manage pain associated with this rare bone and hormonal disorder. (Also known as: Fibrous Dysplasia/McCune-Albright Syndrome, FD/MAS, McCune-Albright Syndrome)
Clinical trial locations
Study on Denosumab for Treating Fibrous Dysplasia/McCune-Albright Syndrome in Adults
This clinical trial is investigating whether Denosumab can help reduce pain in adults living with Fibrous Dysplasia/McCune-Albright Syndrome. The condition causes normal bone to be replaced with fibrous tissue, leading to pain, bone deformities, and fractures. It can also affect the skin and hormone-producing tissues in the body.
Who can participate:
- Adults over 18 years old with confirmed diagnosis and closed growth plates
- Those experiencing pain in affected bone areas that does not improve with standard pain treatment
- Pain level of 4 or higher on a visual scale
- Evidence of increased bone activity shown through blood markers or imaging tests
- Normal levels of calcium, parathyroid hormone, and vitamin D
- Good dental health with a check-up within the last year
- Both men and women are eligible
Who cannot participate:
- Pregnant or breastfeeding women
- People with severe kidney problems
- Those with a history of allergic reactions to Denosumab
- Individuals who recently took certain bone-affecting medications
- People with other serious health conditions that could interfere with the study
- Those unable to follow study procedures or attend follow-up visits
What the trial involves:
The main goal of this study is to evaluate whether Denosumab can effectively reduce pain levels in patients over a six-month period. Participants will receive two injections of the medication under the skin during the first six months. The study includes a placebo group for comparison purposes.
Throughout the 12-month study period, participants will undergo various assessments including questionnaires about pain levels, quality of life, and physical activity. Imaging tests such as bone scans will also be performed to monitor changes in the condition. Researchers will track how much pain medication participants use and measure markers of bone activity in the blood.
The investigational drug:
Denosumab is a monoclonal antibody that works by blocking a protein called RANKL, which is involved in the breakdown of bone tissue. By inhibiting this protein, Denosumab may help reduce bone-related pain in people with this condition. The medication is given as an injection under the skin.
The study will carefully monitor participants for any side effects and track their progress using standardized measurements. After the initial six-month treatment period, some participants may be offered additional treatment with continued monitoring.
Summary
Currently, there is one active clinical trial available for adults with Albright's disease, located in the Netherlands. This trial focuses specifically on pain management using Denosumab, a medication that targets bone breakdown processes. The study represents an important effort to find better treatment options for this rare condition, which can significantly impact quality of life through chronic pain and bone complications.
The trial is designed with careful monitoring and includes both treatment and placebo groups to properly evaluate the medication's effectiveness. Participants must meet specific health criteria and be committed to the 12-month study duration with regular follow-up visits and assessments.
