NCT06809816

Efficacy of OsteoBor in Postmenopausal Osteoporosis

Efficacy of OsteoBor in Postmenopausal Osteoporosis: A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tabriz University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Sodium pentaborate pentahydrate	Sodium pentaborate pentahydrate will be administered orally in capsule form, following the standard protocol outlined in the study design.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-02-05
• Last updated: 2025-02-05