This study aims to evaluate the impact of boron supplementation (OsteoBor) on bone health in postmenopausal women. The trial is a phase 2, randomised, double-blind, placebo-controlled study lasting one year
Osteoporosis is a systemic condition that affects the skeleton, characterised by decreased bone density and the destruction of bone microstructure, resulting in increased fragility and a higher risk of fractures. It disproportionately affects postmenopausal women due to reduced estrogen production, which plays a crucial role in bone metabolism. The disease leads to significant health burdens, including fractures that decrease quality of life and increase healthcare costs. The World Health Organization (WHO) defines osteoporosis as a bone mineral density (BMD) score of T ≤ -2.5, and the prevalence of low BMD continues to rise globally, contributing to the increasing incidence of fractures. This study evaluates OsteoBor, a boron-based supplement, for improving BMD and reducing fracture rates in postmenopausal women in Iran. Boron, a trace mineral, supports bone health by influencing calcium, magnesium, and vitamin D metabolism, and shows promise in reducing inflammation and enhancing antioxidant enzymes. Although animal studies have shown positive effects on bone mineralisation, human studies remain limited. This trial aims to explore the effectiveness of OsteoBor as a potential alternative to existing osteoporosis treatments, which face challenges like side effects and patient adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Sodium pentaborate pentahydrate will be administered orally in capsule form, following the standard protocol outlined in the study design.
The percentage change in areal bone mineral density (aBMD)
The change in areal bone mineral density (aBMD) at the lumbar spine will be evaluated over a 12-month period, comparing the baseline measurement to the final result. This will be assessed using dual-energy X-ray absorptiometry (DXA), a widely used and trusted technique for bone health evaluation. The lumbar spine is particularly important for assessing bone density, as it is a key area affected by osteoporosis, especially in postmenopausal women who are at higher risk of fractures due to changes in hormonal levels.
Time frame: The measurements will be taken at baseline, 6 months, and 12 months.
The percentage change in aBMD at the total hip and femoral neck
It will be measured using dual-energy X-ray absorptiometry (DXA).
Time frame: At baseline, 6 months, and 12 months.
Serum Osteocalcin
Serum osteocalcin is a biomarker for bone formation, and its levels can help assess osteoporosis progression by reflecting the balance between bone resorption and formation. Decreased osteocalcin levels are associated with lower bone formation rates and higher fracture risk, especially in postmenopausal women
Time frame: At baseline, 6 months, and 12 months.
Bone-specific alkaline phosphatase
Bone-specific alkaline phosphatase (BSAP) is a marker of bone formation, primarily produced by osteoblasts, and is elevated in conditions like osteoporosis, reflecting increased bone turnover. Elevated BSAP levels can indicate active bone repair, while lower levels might suggest reduced bone formation, aiding in monitoring osteoporosis progression and treatment effectiveness
Time frame: At baseline, 6 months, and 12 months.
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