Health TrialsbyHealthPanel

Efficacy of OsteoBor in Postmenopausal Osteoporosis

ConditionOsteoporosis, Postmenopausal
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45-85
SponsorTabriz University of Medical Sciences

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sodium pentaborate pentahydrate

    Drug

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Sodium pentaborate pentahydrateExperimental treatment 1 intervention
Group B: PlaceboNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tabriz University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: