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

University of Salerno

Status: Completed

Conditions: Osteoporosis Risk

Treatments: Other: bicarbonate-calcium water

Study type: Interventional

Funder types: Other

Identifiers

NCT05854342

CECN/1522

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

bicarbonate-calcium water

Experimental group

Description:

participants of this group drink bicarbonate-calcium water

Treatment:

Other: bicarbonate-calcium water

low mineral water

No Intervention group

Description:

participants of this group drink low mineral water