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

Not Applicable

Completed

• Conditions: Osteoporosis; Hydrogen Sulfide
• Interventions: Other: inhalatory treatment with sulfureous aerosol

• Registration Number: NCT06095349
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• post-menopausal women with a diagnosis of osteopenia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone turnover markers	inhalatory treatment with sulfureous aerosol	Concentrations of bone turnover markers will be assessed before and after treatment. Correlation will be sought for with H2S levels and clinical features of the patients

Primary Outcome Measures

Name	Time	Method
Measurement of biomarkers of bone turnover, marker #1	15 days	Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation
Measurement of biomarkers of bone turnover, marker #2	15 days	Bone-specific alkaline phosphatase (BAP), marker of bone formation
Measurement of biomarkers of bone turnover, marker #3	15 days	serum C-terminal telopeptide of type I collagen (CTX-1), marker of bone resorption

Secondary Outcome Measures

Name	Time	Method
Measurement of serum H2S levels	15 days	serum H2S levels will be assessed through HPLC

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy