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

Study acronym: ITS-PILOT
StatusRecruiting
PhasePhase 2
Started2020-01-06
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
Trial sites expanded: 8 → 11 locations
2026-07-17
Study Status, Oversight, IPDSharing v15
Primary completion date2027-06-06→2029-06-06
Completion date2027-06-06→2029-06-06
2025-04-01
Study Identification, Study Status, Conditions, Contacts/Locations v14
Primary completion date2025-06-06→2027-06-06
Completion date2025-06-06→2027-06-06
Study sitescontacts updated at 8 of 8 sites
Study titlerevised
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. aA Pilot Study
2025-02-17
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations, IPDSharing v13
Study sites7→8
Study titlerevised
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. Aa Pilot Study
2025-01-16
Study Status v12
Re-verified, no change to tracked fields
Show 11 earlier versions
2023-12-04
Study Status, Contacts/Locations v11
Study sites7 entries, revised
CHU de MONTPELLIERToulouse
2023-05-24
Study Status v10
Primary completion date2023-03→2025-06-06
Completion date2023-03→2025-06-06
2023-03-15
Study Status, Contacts/Locations v9
Study sites5→7
2022-01-06
Study Status v8
Re-verified, no change to tracked fields
2020-09-28
Suspended→Recruiting Study Status, Contacts/Locations v7
Trial statusSuspended→Recruiting
Reason stoppedCovid-19 pandémie→not stated
Study sitesdetails revised at 5 of 5 sites
2020-04-07
Not Yet Recruiting→Suspended Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Suspended
Reason stoppednot stated→Covid-19 pandémie
Start dateestimated 2020-03→confirmed 2020-01-06
Study sitescontacts updated at 5 of 5 sites
2020-03-16
Study Status v5
Primary completion date2023-01→2023-03
Completion date2023-01→2023-03
Start date2020-01→2020-03
2019-12-24
Study Status v4
Primary completion date2022-11→2023-01
Completion date2022-11→2023-01
Start date2019-11→2020-01
2019-10-14
Study Status v3
Primary completion date2022-09→2022-11
Completion date2022-09→2022-11
Start date2019-09→2019-11
2019-09-05
Study Identification, Study Status, Outcome Measures, Eligibility v2
Eligibility criteria+146 characters
[...] calcification secondary to systemic sclerosis Patient aged 62 monthsyears or over Indication of STS infusion validated by a multidisc [...] 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 aff [...]
Secondary endpoints9 to 7 entries
Change of the percentage of patient with a clinically pertinent variation in pain Change of the percentage of patients with a clinically pertinent variation in quality of life
Study title+12 characters
IntralesionalSubcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
2019-06-04
Study Status v1
Primary completion date2022-01→2022-09
Completion date2022-01→2022-09
Start date2019-01→2019-09
2018-06-27
Original filing
Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications/ossifications become too important. Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study. We propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A/iPPSD2) (inactivating parathyroid hormone / parathyroid-hormone-related peptid (PTH/PTHrP) signalling disorder).
Trial Details
NCT Number NCT03582800
Lead Sponsor University Hospital, Limoges
Conditions Systemic Sclerosis, Dermatomyositis, iPPSD2
Enrollment 40 participants
Start Date 2020-01-06
Primary Completion 2029-06-06 (estimated)
Study Completion 2029-06-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-15