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
About this trial
This is an interventional prevention trial for Hydrogen Sulfide
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
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
NCT ID
NCT06095349
First Posted
October 10, 2023
Last Updated
October 18, 2023
Sponsor
Istituto Ortopedico Rizzoli
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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