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

• Sponsor: University of Salerno (Other)
• Overall Status: Completed
• CT.gov ID: NCT05854342
• Collaborator: San Giuseppe Moscati Hospital (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 12

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Risk	Other: bicarbonate-calcium water	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Jan 1, 2022
• Actual Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bicarbonate-calcium water participants of this group drink bicarbonate-calcium water	Other: bicarbonate-calcium water; water with high content of bicarbonate and calcium, low sodium
No Intervention: low mineral water participants of this group drink low mineral water

Outcome Measures

Primary Outcome Measures

1. calcium (mg/dL) [0-3-6 month]

   change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests

2. 25-OH vitamin D (ng/mL) [0-3-6 month]

   change of physiological parameter concentration related to calcium metabolism

3. osteocalcin (ng/mL) [0-3-6 month]

   change of physiological parameter concentration related to calcium metabolism

4. Parathyroid hormone (pg/mL) [0-3-6 month]

   change of physiological parameter concentration related to calcium metabolism

Secondary Outcome Measures

1. NMR metabolomic profile and applications of Metabolomics in calcium metabolism [0-3-6 month]

   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

Other Outcome Measures

1. changes cholesterol total (mg/dL) [0-3-6 month]

   change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests

2. changes cholesterol HDL (mg/dL) [0-3-6 month]

   change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests

3. changes cholesterol LDL (mg/dL) [0-3-6 month]

   change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests

4. changes glycemia (mg/dL) [0-3-6 month]

   change of physiological parameter concentration related to glycemic profile measured by blood laboratory tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Salerno	Salerno		Italy	84084

Sponsors and Collaborators

• University of Salerno
• San Giuseppe Moscati Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 27, 2021
• Statistical Analysis Plan - Jan 27, 2021
• Informed Consent Form - Jan 27, 2021

More Information

Publications

• 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.
• 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.

• Responsible Party: Luca Rastrelli, Principal Investigator Full Professor Luca Rastrelli, University of Salerno
• ClinicalTrials.gov Identifier: NCT05854342
• Other Study ID Numbers: CECN/1522
• First Posted: May 11, 2023
• Last Update Posted: May 11, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Luca Rastrelli, Principal Investigator Full Professor Luca Rastrelli, University of Salerno: bicarbonate-calcium water
• Additional relevant MeSH terms: Osteoporosis; Calcium

Study Results

No Results Posted as of May 11, 2023