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OpenTrials
Completed

NCT Number: NCT06095349

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

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

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Key information

Conditions

Hydrogen Sulfide Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • post-menopausal women with a diagnosis of osteopenia

Exclusion criteria

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

Treatment and study plan

inhalatory treatment with sulfureous aerosol

Other

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

Primary outcomes

  1. Measurement of biomarkers of bone turnover, marker #1

    Time frame: 15 days

    Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation

  2. Measurement of biomarkers of bone turnover, marker #2

    Time frame: 15 days

    Bone-specific alkaline phosphatase (BAP), marker of bone formation

  3. 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

  1. Measurement of serum H2S levels

    Time frame: 15 days

    serum H2S levels will be assessed through HPLC

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: FORST3

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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