In short
This article provides information about ongoing clinical trials investigating treatments for bone hypertrophy, specifically focusing on sternocostoclavicular hyperostosis. Currently, there is 1 active trial evaluating the effectiveness of pamidronate medication in reducing pain associated with abnormal bone growth in the chest area.
Clinical trial locations
- Netherlands
Study of Pamidronate for Pain Relief in Patients with Sternocostoclavicular Hyperostosis (SCCH)
This trial is investigating the use of pamidronate to reduce pain in patients with sternocostoclavicular hyperostosis, a rare condition causing inflammation and abnormal bone growth in the chest wall, particularly affecting the breastbone, ribs, and collarbone area.
Main inclusion criteria:
- Patients aged 12 to 65 years (both males and females)
- Experiencing pain at lesion sites with a severity of at least 6 out of 10 on the pain scale
- Active signs of inflammation visible on medical imaging tests such as X-rays, MRI, or bone scans at the affected areas
- Inflammation in the sternum (breastbone) area or diagnosis of sternocostoclavicular hyperostosis
- No bisphosphonate treatment received in the past 6 months
Main exclusion criteria:
- Age below 12 years or above 65 years
- Known allergies or hypersensitivity to pamidronate or similar medications
- Severe kidney problems or abnormal kidney function
- Low blood calcium levels (hypocalcemia)
- Current pregnancy or breastfeeding
- Active dental problems, upcoming dental procedures, or recent jaw or dental surgery within the last 6 months
- History of cancer within the past 5 years
- Participation in other clinical trials within the last 30 days
- Severe heart, liver, or blood disorders
- Current use of medications that affect bone metabolism or might interact with the study drug
Focus and goals of the trial:
The study aims to determine whether pamidronate treatment given every three months can significantly decrease pain in patients with sternocostoclavicular hyperostosis compared to placebo. Participants will receive either pamidronate or a sodium chloride solution (placebo) through an intravenous infusion every three months for a total treatment period of 6 months. The study will monitor pain levels using standardized assessment tools and track changes in movement ability, general health, and daily activities to understand how the treatment affects patients' quality of life. Medical imaging will be performed to check disease activity at the beginning and end of the study.
Investigational drug:
Pamidronate is a medication belonging to a group of drugs called bisphosphonates. It works by slowing down bone loss and reducing the activity of cells that break down bone tissue. This medication is commonly used to treat conditions affecting bone health and can help reduce bone pain. In this trial, it is being studied for its effectiveness in reducing pain in patients with this rare bone condition. The medication is administered through an intravenous infusion in a hospital or clinic setting under medical supervision, with doses not exceeding 30 milligrams per day or 90 milligrams in total per treatment cycle.
Summary
Currently, there is one active clinical trial specifically investigating treatments for bone hypertrophy, with a focus on sternocostoclavicular hyperostosis. This trial is being conducted in the Netherlands and evaluates pamidronate, a bisphosphonate medication, for its ability to reduce pain associated with abnormal bone growth in the chest area.
The trial represents an important research effort for patients with this rare condition, as treatment options are limited. The study uses a rigorous approach by comparing pamidronate treatment to placebo over a 6-month period, with regular monitoring of pain levels, movement ability, and quality of life. The focus on pamidronate reflects its known properties in treating bone-related conditions and its potential to help manage pain in patients with inflammatory bone disorders.
Patients interested in participating should note that the trial has specific age requirements (12 to 65 years) and requires confirmation of active disease through medical imaging. The trial excludes patients with certain medical conditions, particularly those affecting kidney function, calcium levels, or dental health, as well as pregnant or breastfeeding women.
