Clinical trial: Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment (NCT02371252)

Eligibility criteria:
Inclusion Criteria: patients who are postmenopausal women or men who aged older than 50
        years and meet the indications for osteoporosis treatment according to the Thai
        Osteoporosis Foundation's 2010 treatment guidelines.

          -  History of spinal or hip fractures with low energy trauma.

          -  BMD by Dual energy X-ray absorptiometry (DXA) scan with T-score ≤ -2.5 at the femoral
             neck, total hip, or L1-L4 spine.

          -  BMD by DXA scan with T-score between -1 and -2.5 at the femoral neck, total hip, or
             L1-L4 spine and a 10-year hip fracture probability ≥ 3% or a 10-year major
             osteoporosis-related fracture probability ≥ 20% based on Fracture risk assessment tool
             (FRAX)

        Exclusion Criteria:

          -  Patients who have contraindications to use bisphosphonates e.g. gastroesophageal
             reflux disease or drug allergy to bisphosphonates

          -  Patients with an abnormality of serum calcium levels (more than 10.2 mg/dl or less
             than 8.7 mg/dl)

          -  Patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2

          -  Patients with metabolic bone diseases such as Paget's disease, hyperparathyroidism,
             etc.

          -  Patients who were received anti-osteoporotic drugs during the past 1 year.

          -  Patients who currently taking steroids, hormone replacement therapy, or selective
             estrogen receptor modulators (SERMs) within 1 year.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment