The effect of sodium pentaborate (NaB) supplementation on bone density and serum levels of its related markers in postmenopausal women with primary osteoporosis.

The effect of sodium pentaborate (NaB) supplementation on bone density, serum levels of bone turnover markers and inflammation-related microRNAs in postmenopausal women with primary osteoporosis: a triple blind randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20131009014957N7

Enrollment

Registered

2019-03-30

Start date

2019-06-22

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia. Other disorders of bone density and structure

Interventions

Intervention 1: Intervention group: The Sodium Pentaborate group will receive 5 mg capsules twice daily (every 12 hours) for 6 months. Intervention 2: Control group: Placebo group will receive 5 mg ca

Eligibility

Sex/Gender

Female

Age

50 Years to 65 Years

Inclusion criteria

Inclusion criteria: Postmenopausal women aged 50 to 65 years Menstrual cessation for at least 12 consecutive months Bone density between -1 to -2.5 in the lumbar or femoral neck

Exclusion criteria

Exclusion criteria: Renal diseases and renal failure Bone disease other than osteopenia The use of medications that affect bone metabolism

Design outcomes

Primary

Measure	Time frame
Bone mineral density. Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning the intervention ). Method of measurement: Dual-energy X-ray absorptiometry (DXA).;Serum levels of bone turnover markers (osteocalcin? P1NP? BSAP? CTX). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention). Method of measurement: Using the ELISA method.;Serum levels of osteoporosis MicroRNA (miR422a? miR-133a? miR-21 ? miR-503). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using the Real-Time PCR method.	—

Measure

Time frame

Bone mineral density. Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning the intervention ). Method of measurement: Dual-energy X-ray absorptiometry (DXA).;Serum levels of bone turnover markers (osteocalcin? P1NP? BSAP? CTX). Timepoint: At the baseline (before intervention) and just after completion of the intervention (6 months after beginning of intervention). Method of measurement: Using the ELISA method.;Serum levels of osteoporosis MicroRNA (miR422a? miR-133a? miR-21 ? miR-503). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using the Real-Time PCR method.

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Secondary

Measure	Time frame
Serum levels of biochemical factors (steroid (estrogen and testosterone) and thyroid (T3 and T4) hormones, lipid profiles, insulin resistance, FBS, total calcium, 25 (OH) D, BUN and creatinine). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using Spectrophotometer, ELISA method.;?Serum levels of some inflammatory (TNF-a, HS-CRP, IL-6)and oxidative stress indices (TAC, SOD, MDA). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using Spectrophotometer, Calorie meter, and ELISA method.;Response to treatment based on the frequency of gene polymorphisms (OPG gene rs2062377 polymorphism, RANKL gene rs9533090 polymorphism, LRP5 gene rs3736228 polymorphism, ESR1 gene rs4869742 polymorphism, ZBTB40 gene rs6426749 polymorphism). Timepoint: Completion of the intervention (6 months after beginning intervention ). Method of measurement: Using PCR-RFLP method.;Nutritional status (mean weight, BMI, waist circumference, waist to hip ratio, appetite score). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using the Seca digital scale, the Seca wall mounted stadiometer and the VAS questionnaire.;Body composition analysis score (PBF, MBF, SLM, LBM, VFM, TBW, Mineral). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using Body Composition Analyzer.;Adverse events. Timepoint: During Intervention. Method of measurement: Using a checklist.	—

Measure

Time frame

Serum levels of biochemical factors (steroid (estrogen and testosterone) and thyroid (T3 and T4) hormones, lipid profiles, insulin resistance, FBS, total calcium, 25 (OH) D, BUN and creatinine). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using Spectrophotometer, ELISA method.;?Serum levels of some inflammatory (TNF-a, HS-CRP, IL-6)and oxidative stress indices (TAC, SOD, MDA). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using Spectrophotometer, Calorie meter, and ELISA method.;Response to treatment based on the frequency of gene polymorphisms (OPG gene rs2062377 polymorphism, RANKL gene rs9533090 polymorphism, LRP5 gene rs3736228 polymorphism, ESR1 gene rs4869742 polymorphism, ZBTB40 gene rs6426749 polymorphism). Timepoint: Completion of the intervention (6 months after beginning intervention ). Method of measurement: Using PCR-RFLP method.;Nutritional status (mean weight, BMI, waist circumference, waist to hip ratio, appetite score). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using the Seca digital scale, the Seca wall mounted stadiometer and the VAS questionnaire.;Body composition analysis score (PBF, MBF, SLM, LBM, VFM, TBW, Mineral). Timepoint: At the baseline (before intervention) and completion of the intervention (6 months after beginning intervention ). Method of measurement: Using Body Composition Analyzer.;Adverse events. Timepoint: During Intervention. Method of measurement: Using a checklist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Azizeh Farshbaf-Khalili

Tabriz University of Medical Sciences

farshbafa@tbzmed.ac.ir+98 41 3336 1928

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026