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

Primary Purpose

Hydrogen Sulfide, Osteoporosis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
inhalatory treatment with sulfureous aerosol
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hydrogen Sulfide

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone turnover markers

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measurement of serum H2S levels
serum H2S levels will be assessed through HPLC

Full Information

First Posted
October 10, 2023
Last Updated
October 18, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT06095349
Brief Title
Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.
Acronym
FORST3
Official Title
Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrogen Sulfide, Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone turnover markers
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
inhalatory treatment with sulfureous aerosol
Intervention Description
osteopenic patients are subject to a 12-days cycle of 30 minutes-long inhalatory treatment with sulfureous aerosol
Primary Outcome Measure Information:
Title
Measurement of biomarkers of bone turnover, marker #1
Description
Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation
Time Frame
15 days
Title
Measurement of biomarkers of bone turnover, marker #2
Description
Bone-specific alkaline phosphatase (BAP), marker of bone formation
Time Frame
15 days
Title
Measurement of biomarkers of bone turnover, marker #3
Description
serum C-terminal telopeptide of type I collagen (CTX-1), marker of bone resorption
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Measurement of serum H2S levels
Description
serum H2S levels will be assessed through HPLC
Time Frame
15 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
post-menopausal women, a condition which is associated with the development of osteoporosis
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: post-menopausal women with a diagnosis of osteopenia Exclusion Criteria: concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Grassi, Ph.D
Phone
+390516366893
Email
francesco.grassi@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Brunella Grigolo, Ph.D
Phone
+390516366090
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Grassi

12. IPD Sharing Statement

Learn more about this trial

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

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