Osteoporosis, PostmenopausalPhase 2NCT06809816
Efficacy of OsteoBor in Postmenopausal Osteoporosis
A Phase 2 study testing Sodium pentaborate pentahydrate in people with Osteoporosis, Postmenopausal, run by Tabriz University of Medical Sciences.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Sodium pentaborate pentahydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of OsteoBor in Postmenopausal Osteoporosis: A Randomized, Double-Blinded, Placebo-Controlled Phase 2 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
Read the 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
- Being tested
- Sodium pentaborate pentahydrate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium pentaborate pentahydrateDrug
Sodium pentaborate pentahydrate will be administered orally in capsule form, following the standard protocol outlined in the study design.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
It will be measured using dual-energy X-ray absorptiometry (DXA).
Measured: 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
Measured: 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
Measured: At baseline, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabriz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Saeid Safiri, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809816
- Sponsor's protocol ID
- 75397
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of OsteoBor in Postmenopausal Osteoporosis: A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial
- ClinicalTrials.gov ID
- NCT06809816
- Acronym / sponsor ID
- 75397
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tabriz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium pentaborate pentahydrate | Experimental | Drug: Sodium pentaborate pentahydrateIn 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. |
| 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium pentaborate pentahydrateSodium pentaborate pentahydrate will be administered orally in capsule form, following the standard protocol outlined in the study design. | Drug | Sodium pentaborate pentahydrate |
Primary outcome
The percentage change in areal bone mineral density (aBMD)
Time frame: The measurements will be taken at baseline, 6 months, and 12 months.
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.
3 secondary outcomes
The percentage change in aBMD at the total hip and femoral neck
Time frame: At baseline, 6 months, and 12 months.
Serum Osteocalcin
Time frame: At baseline, 6 months, and 12 months.
Bone-specific alkaline phosphatase
Time frame: At baseline, 6 months, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium pentaborate pentahydrate in people with Osteoporosis, Postmenopausal, run by Tabriz University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saeid Safiri, PhD (00989141005277, saeidsafiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change in areal bone mineral density (aBMD) (time frame: The measurements will be taken at baseline, 6 months, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.