Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water

Official Title
-----------------
Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis

Conditions
-----------------
Osteoporosis Risk

Intervention / Treatment
-----------------
* Other: bicarbonate-calcium water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal women aged ≥40 years Menopausal women, period of early menopause 1-10 years Exclusion Criteria: Inclusion in other study protocols estrogen-replacement hormone therapy osteoporosis therapy corticosteroid therapy insulin therapy. calcium supplementation kidney diseases of medium-severe level liver diseases of medium-severe level severe osteoporosis
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bicarbonate-calcium water<br>participants of this group drink bicarbonate-calcium water | Other: bicarbonate-calcium water<br>* water with high content of bicarbonate and calcium, low sodium<br>|
| No Intervention: low mineral water<br>participants of this group drink low mineral water | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calcium (mg/dL) | change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests | 0-3-6 month | 
| 25-OH vitamin D (ng/mL) | change of physiological parameter concentration related to calcium metabolism | 0-3-6 month | 
| osteocalcin (ng/mL) | change of physiological parameter concentration related to calcium metabolism | 0-3-6 month | 
| Parathyroid hormone (pg/mL) | change of physiological parameter concentration related to calcium metabolism | 0-3-6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NMR metabolomic profile and applications of Metabolomics in calcium metabolism | Metabolomic profile of serum related to calcium metabolism by NMR proton Nuclear Magnetic Resonance spectroscopy (1H-NMR) Metabolomics aims at the quantitative analysis of all metabolites in a biological system, as well as their composition, interactions, and responses to interventions or a specific physiological state. The metabolomics approach correlates broad biochemical changes with health and disease states, and advanced statistical metabolic modeling allows the identification of biomarkers, enabling the quantification of low-molecular-weight metabolites | 0-3-6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bicarbonate-calcium water