FORST3: Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Recruiting

CT.gov ID

NCT06095349

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hydrogen Sulfide Osteoporosis	Other: inhalatory treatment with sulfureous aerosol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bone turnover markers 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	Other: inhalatory treatment with sulfureous aerosol osteopenic patients are subject to a 12-days cycle of 30 minutes-long inhalatory treatment with sulfureous aerosol

Arm

Intervention/Treatment

Experimental: Bone turnover markers

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

Other: inhalatory treatment with sulfureous aerosol

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

Outcome Measures

Primary Outcome Measures

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

Measurement of serum H2S levels [15 days]
serum H2S levels will be assessed through HPLC

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

post-menopausal women with a diagnosis of osteopenia

Exclusion Criteria:

concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Ortopedico Rizzoli	Bologna		Italy	40136

Sponsors and Collaborators

Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Ortopedico Rizzoli

ClinicalTrials.gov Identifier:

NCT06095349

Other Study ID Numbers:

FORST3

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Oct 23, 2023