Efficacy of OsteoBor in Postmenopausal Osteoporosis

Prior treatment

• 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.
• 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.

Other illness

• 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.
• 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.

Lab values

• 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.
• Allergies and Sensitivities: Known allergies or sensitivities to boron supplements, calcium, vitamin D, or other components of the study drugs.

Other

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• 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.
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