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Trial · NCT03582800

Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

NCT03582800, Phase 2, Recruiting, University Hospital, Limoges

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study. Trials, record NCT03582800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03582800

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
NCT number
NCT03582800
Status
Recruiting
Phases
Phase 2
Enrollment
40 participants, estimated
Lead sponsor
University Hospital, Limoges
Conditions
Systemic Sclerosis, Dermatomyositis, iPPSD2
Interventions
STS
First posted
2018-07-11
Last updated
2026-09-15

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange of the percentage of volume of the treated calcifications / ossificationsbetween Month 6 and Month 12
Calculation of percentage of volume evolution of the treated calcification / ossification between the beginning and the end of STS treatment, in each of the three diseases (dermatomyositis, systemic sclerosis and iPPSD2), evaluated on CT-scan measurements.
SecondaryChange of the volume of the treated calcifications / ossificationsMonth 0, Month 6 and Month 12
Calculation of volume of the treated calcification / ossification at (i) inclusion, the end of the run-in period (6 month) and after 6 months of local injections of STS in each disease (12 month), evaluated on CT-scan measurements.
SecondaryAdverse eventsMonth 12Collection of adverse events (clinical and biological): causality, severity, and seriousness during the STS treatment.
SecondaryChange of the Hounsfield density of the treated ectopic calcifications/ossificationsMonth 0, Month 6 and Month 12
Hounsfield density analysis of the treated ectopic calcifications/ossifications at inclusion, the end of the run-in period (6 month) and after 6 months of local injections of STS (12 month), evaluated on CT-scan measurements.
SecondaryChange of the percentage of patient with a clinically pertinent variation in painBetween Month0 and Month 6 and Between Month 6 and Month 12
Calculation of Percentage of patients with a clinically pertinent variation in pain evaluated with pain scales: difference in hetero-evaluation scale of pain in children (HEDEN) ≥ 2 (2-7 years old) between M0-M6 and M6-M12
SecondaryChange of the percentage of patient with a clinically pertinent variation in painBetween Month0 and Month 6 and Between Month 6 and Month 12
Calculation of Percentage of patients with a clinically pertinent variation in pain evaluated with pain scales: difference in visual analogue pain intensity scale (VAS) score ≥ 2 (\> 7 years old) between M0-M6 and M6-M12
SecondaryChange of the percentage of patients with a clinically pertinent variation in quality of lifeBetween Month0 and Month 6 and Between Month 6 and Month 12Calculation of percentage of patients with a clinically pertinent variation in quality of life : difference in PedsQL ≥ 5 (2-18 years old, using appropriates reports) between M0-M6 and M6-M12
SecondaryChange of the percentage of patients with a clinically pertinent variation in quality of lifeBetween Month0 and Month 6 and Between Month 6 and Month 12Calculation of percentage of patients with a clinically pertinent variation in quality of life : difference in Short Form 36 (SF36) score ≥ 20 (\> 18 years old) between M0-M6 and M6-M12

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03582800

GET https://conductscience.org/api/trials/v1/NCT03582800/registered