A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus); Calcitriol; Calcium 500 mg
Intervention description: one combination tablet once weekly; 0.25 μg once daily orally; one 500 mg tablet once daily
Intervention MeSH terms: Vitamin D; Cholecalciferol; Alendronate; Calcitriol; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: Female
Minimum age: 56 Years
Healthy volunteers: No

Summary:

      This study will evaluate whether the once weekly administration of the combination tablet
      alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD)
      more than the daily use of calcitriol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets one of the following BMD criteria:

          -  Has BMD T-score ≤-2.5 in at least one of the anatomic sites including lumbar spine,
             total hip, and femoral neck, OR

          -  Has prior non-pathological fragility fracture (of spine, wrist, humerus or clavicle)
             and BMD T-score ≤-1.5 in at least one of the anatomic sites including lumbar spine,
             total hip, and femoral neck sites

          -  Must have a baseline 25-hydroxyvitamin D ≥8 ng/mL (20 nmol/L)

          -  Is ambulatory

          -  Has been postmenopausal for at least one year

        Exclusion Criteria:

          -  Has any contraindication to alendronate, including abnormalities of the esophagus
             which delay esophageal emptying (such as stricture or achalasia), or inability to
             stand/sit upright for at least 30 minutes, or hypersensitivity to alendronate and
             vitamin D, or hypocalcemia

          -  Has any contraindications to calcitriol, and/or vitamin D, including hypercalcemia,
             hypercalciuria, or active kidney stone disease

          -  Had a prior hip fracture

          -  Has received treatment with any of the following: anabolic steroid agent within the
             past 12 months, systemic glucocorticoids for more than 2 weeks in the past 6 months,
             oral bisphosphonates more than 3 months within the past 2 years, any lifetime use of
             an intravenous administration of zoledronate, immunosuppressant other than
             methotrexate, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks
             within the past 3 months, strontium containing products for more than 2 weeks within
             the past 6 months, Parathyroid hormone for more than 2 weeks within the past 3 months,
             current use of chemotherapy, or heparin, growth hormone for more than 2 weeks within
             the past 6 months, active hormonal vitamin D analogs (e.g., alphacalcidol, calcitriol)
             in the past 30 days, or more than 5 days treatment of active hormonal vitamin D
             analogs between 30 and 60 days prior to study entry., use of vitamin A (excluding beta
             carotene) >10,000 IU daily, unless willing to discontinue this dose during the study,
             current use of, lithium, or anti-convulsants, current use of calcium supplement in
             amount excess of 1500 mg daily, unless willing to discontinue this dose during the
             study, estrogen with or without progestin within the prior 6 months, Raloxifene or
             other selective estrogen receptor modulator ([SERM] including tamoxifen), tibolone, or
             an aromatase inhibitor within the prior 6 months and/or sub-cutaneous calcitonin or
             intra-nasal calcitonin within the prior 6 months

          -  Has a history of malignancy within previous 5 years

          -  Has one or more of the following concomitant conditions: uncontrolled upper
             gastrointestinal disorders, myocardial infarction, unstable angina, stroke and
             revascularization condition within 3 months, malabsorption syndrome, uncontrolled
             primary or secondary hyperparathyroidism, uncontrolled thyroid disease, renal
             insufficiency, uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine,
             hematologic, neurological, psychiatric, or pulmonary diseases; unexplained laboratory
             test abnormality or other conditions, uncontrolled hypertension, new onset diabetes
             (within 3 months), poorly controlled hyperglycemia or abnormal fasting glucose,
             hypoglycemia for any cause, history of, or evidence for metabolic bone disease other
             than osteoporosis, abnormal serum calcium or phosphate, and/or active renal stone
             disease when a calcium supplement is contraindicated