Non-communicable Diseases. Osteoporosis with current pathological fracture
Conditions
Interventions
Intervention 1: Intervention group: Participants in the experimental group will receive 1000 mg of boron daily, while the control group will receive a placebo. OsteoBor will be administered orally, as
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: Age Range: Postmenopausal women aged 45 to 85 years. Menopausal status must be confirmed, with at least 1 year having passed since the last menstrual period. Bone Mineral Density (BMD): A T-score of -2.5 or less in the lumbar spine, total hip, or femoral neck, but not lower than -3.5. General Health: Participants must be generally healthy, with no significant chronic diseases that could affect bone health or the outcome assessments. 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 duration. Informed Consent: Participants must sign written informed consent prior to enrolment, confirming their understanding of the study design, interventions, and potential risks.
Exclusion criteria
Exclusion criteria: History of Fractures: A history of hip fractures or more than one prior clinical vertebral fracture. Any fractures other than hip fractures (except for finger or toe fractures or skull fractures) 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 may affect bone health. Kidney-Liver Issues and Calcium Metabolism: Severe renal insufficiency, defined as serum creatinine levels higher than 1.6 mg/dL, or a history of kidney stones. Abnormalities in serum calcium, 25-hydroxyvitamin D, or parathyroid hormone (PTH) levels. Prohibited Medications: Use of oral bisphosphonates in the past 6 months or prolonged use for more than 6 months at any point in the past. Any use of IV bisphosphonates, including zoledronate, in the year prior to the study. Use of denosumab, teriparatide, or any anabolic or bone-specific drugs in the past 12 months. Use of systemic glucocorticoids (equivalent to more than 5 mg/day of prednisone) for more than 2 weeks in the past 6 months. Use of active vitamin D, strontium ranelate, or other investigational agents for bone health in the past 3 months. Chronic Diseases: Conditions affecting bone metabolism or physical mobility, such as uncontrolled thyroid disease, uncontrolled diabetes, or severe gastrointestinal disorders that impact nutrient absorption. Any condition causing persistent tremors that may interfere with imaging studies 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 per day) or substance abuse that could affect study compliance and bone health. Allergies and Sensitivities: Known allergies or sensitivities to boron, calcium, vitamin D supplements, or other components of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in areal bone mineral density (aBMD): The primary outcome will be the percentage change in aBMD at the lumbar spine from baseline to 12 months. This will be measured using dual-energy X-ray absorptiometry (DXA). The lumbar spine is a critical site for assessing bone health, particularly in postmenopausal women who are at higher risk for osteoporosis and fractures. Timepoint: At baseline, 6 months, and 12 months. Method of measurement: It will be measured using dual-energy X-ray absorptiometry (DXA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in aBMD at other sites: The percentage change in aBMD at the total hip and femoral neck. Timepoint: At baseline, 6 months, and 12 months. Method of measurement: It will be measured using dual-energy X-ray absorptiometry (DXA).;C-terminal telopeptide of type I collagen (CTX) is a marker of bone resorption. Timepoint: At baseline, 6 months, and 12 months. Method of measurement: Immunoassay.;Serum Osteocalcin. Timepoint: At baseline, 6 months, and 12 months. Method of measurement: Enzyme-Linked Immunosorbent Assay.;Bone-specific alkaline phosphatase. Timepoint: At baseline, 6 months, and 12 months. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Safiri
Tabriz University of Medical Sciences
Outcome results
None listed