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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2023
  • participants needed
    40
  • sponsor
    University Hospital, Limoges
Updated on 25 January 2021
calcium
parathyroid hormone
computerized tomography
progressive systemic sclerosis
dermatomyositis

Summary

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).

Details
Condition Dermatomyositis, CONNECTIVE TISSUE DISEASE, Scleroderma, Systemic sclerosis, Dermatosis, Polymyositis, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Polymyositis (Inflammatory Muscle Disease), Skin Conditions, Connective Tissue Diseases, iPPSD2, progressive systemic sclerosis
Treatment STS, STS
Clinical Study IdentifierNCT03582800
SponsorUniversity Hospital, Limoges
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note