In short
There is currently 1 ongoing clinical trial investigating potential treatments for extraskeletal ossification. This trial is testing sodium thiosulfate injections for patients with abnormal calcium deposits or bone formations caused by specific underlying conditions including dermatomyositis, systemic sclerosis, and iPPSD2. The trial is being conducted in France and aims to evaluate whether this treatment can reduce these abnormal growths and improve quality of life for affected patients.
Clinical trial locations
Study of Sodium Thiosulfate Injections for Patients with Ectopic Calcifications or Ossifications from Dermatomyositis, Systemic Sclerosis, or iPPSD2
This trial is investigating whether sodium thiosulfate injections can help reduce abnormal calcium deposits and bone formations that occur outside of the normal skeleton. These growths can develop in patients with three specific conditions: dermatomyositis, systemic sclerosis, and a rare genetic disorder called iPPSD2.
Main inclusion criteria: The trial accepts patients aged 18 years or older who have abnormal calcium deposits caused by dermatomyositis or systemic sclerosis. It also includes younger patients between 2 and 30 years old who have abnormal bone formations due to iPPSD2. Participants must have their need for treatment confirmed by a panel of medical experts based on the significant impact these growths have on their health. Women of childbearing age must use highly effective birth control during the study and for one month afterward, while men with partners who can become pregnant should use condoms during treatment and for 91 days after the last injection. Patients should not have any surgeries planned for their calcifications or ossifications in the next 12 months.
Main exclusion criteria: The trial cannot accept patients whose abnormal growths are caused by conditions other than those specified. Pregnant or breastfeeding women are not eligible. Patients with a history of allergic reactions to the treatment being tested, those currently participating in another clinical trial, or those with severe health conditions that could interfere with the study are excluded. Additionally, patients who have had recent surgery, are planning surgery during the study period, or cannot comply with the study procedures and visits are not eligible.
Trial focus and goals: The main goal of this trial is to determine how effective sodium thiosulfate injections are in reducing the size of abnormal calcium deposits and bone formations over a six-month treatment period. The study begins with a six-month observation period where no treatment is given, which helps establish baseline measurements of the growths using CT scans. Following this, participants receive sodium thiosulfate injections under the skin directly into the affected areas for six months. Throughout the treatment phase, doctors monitor the volume of the growths using imaging techniques and assess any changes in pain levels and quality of life. The trial also carefully tracks any side effects or adverse events that may occur during treatment.
Investigational drug: Sodium thiosulfate is the medication being tested in this trial. It is a chelating agent that works at the molecular level by binding to calcium deposits and helping to dissolve them. The solution is prepared at a 10% concentration and administered through subcutaneous injections, meaning it is injected under the skin. This treatment approach aims to reduce the abnormal accumulations of calcium and bone in soft tissues, potentially improving mobility, reducing discomfort, and enhancing overall quality of life for patients with these challenging conditions.
Summary
Currently, there is one active clinical trial addressing extraskeletal ossification and related conditions. This trial is located in France and focuses specifically on patients whose abnormal growths are caused by dermatomyositis, systemic sclerosis, or iPPSD2. The study represents an important effort to find effective treatments for these difficult-to-manage conditions, which can significantly impact daily life and mobility. Sodium thiosulfate, the drug being investigated, offers a potential non-surgical approach to managing these abnormal calcium and bone deposits. The trial's design, which includes both an observation period and a treatment phase, allows researchers to carefully measure the treatment's effects and gather comprehensive safety data.
