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

Primary Purpose

Osteoporosis Postmenopausal

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
alendronate sodium (+) cholecalciferol
Comparator: Alendronate sodium (Fosamax)
Comparator: Calcium
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis Postmenopausal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Alendronate sodium/Cholecalciferol

    Alendronate sodium

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment

    Full Information

    First Posted
    August 5, 2008
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00729651
    Brief Title
    Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
    Official Title
    A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 20, 2008 (Actual)
    Primary Completion Date
    April 10, 2009 (Actual)
    Study Completion Date
    April 10, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To demonstrate the efficacy/safety of Fosamax Plus D

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis Postmenopausal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    343 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Alendronate sodium/Cholecalciferol
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Alendronate sodium
    Intervention Type
    Drug
    Intervention Name(s)
    alendronate sodium (+) cholecalciferol
    Other Intervention Name(s)
    Fosamax Plus D
    Intervention Description
    Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Alendronate sodium (Fosamax)
    Intervention Description
    Alendronate sodium; tablet, once weekly, for 16 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Comparator: Calcium
    Intervention Description
    500 mg oral tablet calcium once daily, for 16 weeks
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
    Time Frame
    Baseline and 16 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    24719139
    Citation
    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 D(3) 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.
    Results Reference
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    Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

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