Using sodium thiosulfate injections to treat ectopic calcifications and ossifications
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
PHASE2 · University Hospital, Limoges · NCT03582800
This study is testing whether sodium thiosulfate injections can help reduce pain and improve life for people with rare conditions that cause unwanted calcium buildup in their bodies.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | University Hospital, Limoges (other) |
| Locations | 8 sites (Bordeaux and 7 other locations) |
| Trial ID | NCT03582800 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the use of subcutaneous sodium thiosulfate injections to treat ectopic calcifications and ossifications associated with conditions like systemic sclerosis, dermatomyositis, and iPPSD2. The study aims to assess the efficacy of sodium thiosulfate, which is traditionally used for cyanide poisoning, in alleviating pain and improving quality of life for patients suffering from these rare complications. Participants will be monitored for significant morbidity and functional impact related to their calcifications or ossifications, with a focus on those who are not candidates for surgical intervention. The study will include patients aged 2 years and older who meet specific inclusion criteria and have provided informed consent.
Who should consider this trial
Good fit: Ideal candidates include patients aged 2 years or older with ectopic calcifications or ossifications due to systemic sclerosis, dermatomyositis, or iPPSD2.
Not a fit: Patients who are scheduled for surgery on their calcifications or ossifications within the next twelve months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients with ectopic calcifications and ossifications.
How similar studies have performed: While there have been case reports on the use of sodium thiosulfate for similar conditions, this approach is largely novel and has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient presenting with: * ectopic ossification secondary to iPPSD2 or * ectopic calcification secondary to dermatomyositis or * ectopic calcification secondary to systemic sclerosis * Patient aged 2 years or over * Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and/or functional impact of the targeted calcification/ossification * Patient with no planned surgery of the calcifications/ossifications for the twelve coming months * Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence) * Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection. * Informed consent signed by the patient / parents * Patient affiliated to the social security system Exclusion Criteria: * Allergy to STS or one of the excipients used * Contraindication to local injection of STS * Anticoagulant therapy * Pregnant, parturient or breastfeeding woman * Patient deprived of freedom by a court judgment or an administrative decision * Patient undergoing psychiatric care under coercion * Legally protected adult patients (guardianship / curatorship) * Patient unable to give consent * Patient placed under judicial protection
Where this trial is running
Bordeaux and 7 other locations
- CHU de BORDEAUX — Bordeaux, France (RECRUITING)
- Hospice Civil de Lyon — Bron, France (NOT_YET_RECRUITING)
- ApHp - Hôpital Bicêtre — Le Kremlin-Bicêtre, France (RECRUITING)
- CHU de Limoges — Limoges, France (RECRUITING)
- ApHp - hôpital Lariboisière — Paris, France (RECRUITING)
- Hôpital de la Pitié Salpétriêre — Paris, France (NOT_YET_RECRUITING)
- CHU de ROUEN — Rouen, France (NOT_YET_RECRUITING)
- CHU de Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Vincent GUIGONIS, MD — University Hospital, Limoges
- Study coordinator: Vincent GUIGONIS, MD
- Email: vincent.guigonis@unilim.fr
- Phone: 555056358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Systemic Sclerosis, Dermatomyositis, iPPSD2, Sodium thiosulfate, Ectopic calcification, Ectopic Ossification