Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Measurement of biomarkers of bone turnover, marker #1
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •post-menopausal women with a diagnosis of osteopenia
Exclusion Criteria
- •concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism
Outcomes
Primary Outcomes
Measurement of biomarkers of bone turnover, marker #1
Time Frame: 15 days
Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation
Measurement of biomarkers of bone turnover, marker #2
Time Frame: 15 days
Bone-specific alkaline phosphatase (BAP), marker of bone formation
Measurement of biomarkers of bone turnover, marker #3
Time Frame: 15 days
serum C-terminal telopeptide of type I collagen (CTX-1), marker of bone resorption
Secondary Outcomes
- Measurement of serum H2S levels(15 days)