Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.

Osteoporosis Clinical Trial

— FORST3  

Official title:

Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095349
• Other study ID #: FORST3
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate whether inhalation treatment with high-sulfide waters from some spas (referred to as "thermal waters"), performed for 12 consecutive days, is able to change circulating H2S levels and alter bone metabolism. Identifying a clear correlation between circulating levels of H2S and sulfur water administration, as well as a potential anabolic effect on bone, would set the stage for new studies that could have important clinical implications for promoting health and preventing osteoporosis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

Inclusion Criteria:

• post-menopausal women with a diagnosis of osteopenia

Exclusion Criteria:

• concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• inhalatory treatment with sulfureous aerosol
osteopenic patients are subject to a 12-days cycle of 30 minutes-long inhalatory treatment with sulfureous aerosol

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of biomarkers of bone turnover, marker #1	Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation	15 days
Primary	Measurement of biomarkers of bone turnover, marker #2	Bone-specific alkaline phosphatase (BAP), marker of bone formation	15 days
Primary	Measurement of biomarkers of bone turnover, marker #3	serum C-terminal telopeptide of type I collagen (CTX-1), marker of bone resorption	15 days
Secondary	Measurement of serum H2S levels	serum H2S levels will be assessed through HPLC	15 days