Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
Intervention description: One combination tablet orally once a week
Intervention MeSH terms: Vitamin D; Cholecalciferol; Alendronate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Osteoporosis; Postmenopausal

Summary:

      This study will assess the effect of 26 weeks of once-weekly treatment with
      MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600)
      on serum levels of 25-hydroxyvitamin D [25(OH)D].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man aged 50 or older, or a woman who is postmenopausal on day of signing informed
             consent or has been menopausal for at least one year

          -  Meets bone mineral density (BMD) criteria

          -  Agree to discontinue any osteoporosis drug treatment for duration of study

        Exclusion Criteria:

          -  Any contraindication to alendronate and vitamin D

          -  Not ambulatory

          -  Has received treatment with any anabolic steroid agent within the past 12 months,
             systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of
             immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2
             weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2
             weeks within the past 3 months, current use of chemotherapy or heparin, use of growth
             hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin
             D analogs in the past 2 months, current use of vitamin A >10,000 IU daily, current use
             of, lithium, or anti-convulsants including barbiturates, hydantoins, and
             carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily,
             and/or current use of Vitamin D supplement

          -  History of malignancy <5 years, except adequately treated basal cell or squamous cell
             skin cancer and in situ cervical cancer

          -  One or more of the following concomitant conditions: Upper gastrointestinal (GI)
             disorders not adequately controlled; myocardial infarction, unstable angina, stroke
             and revascularization condition within 3 months; malabsorption syndrome; primary or
             secondary hyperparathyroidism not adequately treated; thyroid disease not adequately
             controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular,
             hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary
             diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly
             controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone
             disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active
             renal stone disease

          -  User of illicit recreational drugs or has had a recent history (within the last year)
             of drug or alcohol abuse or dependence

          -  Heavy consumer of alcohol or alcohol containing products.