Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

Overview

To demonstrate the efficacy/safety of Fosamax Plus D

Full Title of Study: “A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 10, 2009

Interventions

  • Drug: alendronate sodium (+) cholecalciferol
    • Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
  • Drug: Comparator: Alendronate sodium (Fosamax)
    • Alendronate sodium; tablet, once weekly, for 16 weeks
  • Dietary Supplement: Comparator: Calcium
    • 500 mg oral tablet calcium once daily, for 16 weeks

Arms, Groups and Cohorts

  • Experimental: 1
    • Alendronate sodium/Cholecalciferol
  • Active Comparator: 2
    • Alendronate sodium

Clinical Trial Outcome Measures

Primary Measures

  • Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
    • Time Frame: 16 weeks

Secondary Measures

  • Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
    • Time Frame: Baseline and 16 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study – Patient has been diagnosed with osteoporosis – Patient has been postmenopausal for more than 6 months – Patient has no contraindication to taking oral bisphosphonates – Patient is eligible for dual energy x-ray absorptiometry in spine or hip Exclusion Criteria:

  • Patients with esophageal dysfunction – Patients who can not sit or stand at least 30 minutes – Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial – Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism – Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

Citations Reporting on Results

Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D₃ 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1. Erratum in: Yonsei Med J. 2014 Jul 1;55(4):1163.

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