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

Osteoporosis Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05854342
• Other study ID #: CECN/1522
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2023
• Source: University of Salerno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Risk

Intervention

Other:
• bicarbonate-calcium water
water with high content of bicarbonate and calcium, low sodium

Locations

Country	Name	City	State
Italy	University of Salerno	Salerno

Sponsors (2)

Lead Sponsor	Collaborator
University of Salerno	San Giuseppe Moscati Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Meunier PJ, Jenvrin C, Munoz F, de la Gueronniere V, Garnero P, Menz M. Consumption of a high calcium mineral water lowers biochemical indices of bone remodeling in postmenopausal women with low calcium intake. Osteoporos Int. 2005 Oct;16(10):1203-9. doi: 10.1007/s00198-004-1828-6. Epub 2005 Mar 3. — View Citation

Wynn E, Krieg MA, Aeschlimann JM, Burckhardt P. Alkaline mineral water lowers bone resorption even in calcium sufficiency: alkaline mineral water and bone metabolism. Bone. 2009 Jan;44(1):120-4. doi: 10.1016/j.bone.2008.09.007. Epub 2008 Sep 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes cholesterol total (mg/dL)	change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests	0-3-6 month
Other	changes cholesterol HDL (mg/dL)	change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests	0-3-6 month
Other	changes cholesterol LDL (mg/dL)	change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests	0-3-6 month
Other	changes glycemia (mg/dL)	change of physiological parameter concentration related to glycemic profile measured by blood laboratory tests	0-3-6 month
Primary	calcium (mg/dL)	change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests	0-3-6 month
Primary	25-OH vitamin D (ng/mL)	change of physiological parameter concentration related to calcium metabolism	0-3-6 month
Primary	osteocalcin (ng/mL)	change of physiological parameter concentration related to calcium metabolism	0-3-6 month
Primary	Parathyroid hormone (pg/mL)	change of physiological parameter concentration related to calcium metabolism	0-3-6 month
Secondary	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