Efficacy of OsteoBor in Postmenopausal Osteoporosis

NCT06809816 | Not Yet Recruiting Phase 2

• 1 other identifier: 75397
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

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.

  The measurements will be taken at baseline, 6 months, and 12 months.

Secondary Outcomes (3)

• The percentage change in aBMD at the total hip and femoral neck

  At baseline, 6 months, and 12 months.

• Serum Osteocalcin

  At baseline, 6 months, and 12 months.

• Bone-specific alkaline phosphatase

  At baseline, 6 months, and 12 months.

Study Arms (2)

Sodium pentaborate pentahydrate

EXPERIMENTAL

In this study, participants in the experimental group will receive 1000 mg of boron daily. OsteoBor will be administered orally, following the dosage recommendations provided by previous studies. Additionally, all participants will receive standard daily doses of 1200 mg of calcium and 800 IU of vitamin D3 supplements.

Drug: Sodium pentaborate pentahydrate

Placebo

NO INTERVENTION

The placebo capsules used in the study will be visually identical to the OsteoBor capsules in terms of appearance and packaging. These capsules will be administered in the same way as the OsteoBor to maintain blinding and ensure that participants are unaware of their group allocation.

Interventions

Sodium pentaborate pentahydrate DRUG

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

Sodium pentaborate pentahydrate

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age Range: Postmenopausal women aged 45 to 85 years. Menopause status must be confirmed, with at least 1 year since the last menstrual period.
• Bone Mineral Density (BMD): T-score at the lumbar spine, total hip, or femoral neck should be ≤ -2.5 but \> -3.5.
• General Health: Participants must be generally healthy with no significant chronic diseases that could affect bone health or the assessment of outcomes.
• Compliance with OsteoBor: All participants must be willing to adhere to daily intake of OsteoBor or placebo, along with calcium (1200 mg) and vitamin D (800 IU) supplements throughout the study.
• Informed Consent: Participants must sign written informed consent before enrolment and confirm their understanding of the study design, interventions, and potential risks.

You may not qualify if:

• History of Fractures: A history of hip fractures or more than one clinical fracture in the spine. Any fractures other than hip fractures (except for fractures of fingers, toes, or the skull) within the past 24 months.
• Other Bone Diseases: Presence of metabolic bone disorders other than osteoporosis, such as Paget's disease, osteomalacia, or hyperparathyroidism. Rheumatoid arthritis or other inflammatory joint diseases that could affect bone health.
• Kidney-Liver Problems \& Calcium Metabolism: Severe kidney failure, defined as serum creatinine levels above 1.6 mg/dL, or a history of kidney stones. Abnormalities in serum calcium levels, 25-hydroxy vitamin D, or parathyroid hormone (PTH) levels.
• Prohibited Medications: Use of oral bisphosphonates in the past 6 months or long-term use (more than 6 months) at any time in the past. Any use of IV bisphosphonates, including zoledronate, in the year prior to the study. Use of denosumab, teriparatide, or any anabolic bone drug within the past 12 months. Use of systemic glucocorticoids (equivalent to more than 5 mg/day of prednisone) for over 2 weeks in the past 6 months. Use of active vitamin D, strontium ranelate, or other investigational bone health agents in the past 3 months.
• Chronic Diseases: Diseases affecting bone metabolism or physical mobility, such as uncontrolled thyroid disease, uncontrolled diabetes, or severe gastrointestinal disorders that affect nutrient absorption. Any conditions that cause persistent tremors that might interfere with imaging or medication adherence.
• Previous Participation in Other Studies: Recent participation in clinical trials involving investigational drugs or supplements for bone health within the past 12 months.
• Alcohol and Drug Use: Heavy alcohol consumption (\>2 drinks/day) or substance abuse that could affect study compliance and bone health.
• Allergies and Sensitivities: Known allergies or sensitivities to boron supplements, calcium, vitamin D, or other components of the study drugs.

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Saeid Safiri, PhD

CONTACT

00989141005277; saeidsafiri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01