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Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Postmenopausal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Fosamax Plus

    Arm Description

    Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants

    Outcomes

    Primary Outcome Measures

    Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
    Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.

    Secondary Outcome Measures

    Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
    Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.

    Full Information

    First Posted
    September 19, 2011
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01437111
    Brief Title
    Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
    Official Title
    A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 26, 2011 (Actual)
    Primary Completion Date
    December 5, 2012 (Actual)
    Study Completion Date
    December 5, 2012 (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
    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].

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fosamax Plus
    Arm Type
    Experimental
    Arm Description
    Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants
    Intervention Type
    Drug
    Intervention Name(s)
    MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
    Other Intervention Name(s)
    Fosamax Plus 70/5600
    Intervention Description
    One combination tablet orally once a week
    Primary Outcome Measure Information:
    Title
    Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
    Description
    Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.
    Time Frame
    Week 26
    Secondary Outcome Measure Information:
    Title
    Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
    Description
    Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
    Time Frame
    Baseline and Week 26

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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.

    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
    30400864
    Citation
    Songpatanasilp T, Rojanasthien S, Sugkraroek P, Ongphiphadhanakul B, Robert L, Robert CS, Luevitoonvechkij S, Santora AC. Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand. BMC Musculoskelet Disord. 2018 Nov 6;19(1):392. doi: 10.1186/s12891-018-2309-y.
    Results Reference
    derived

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    Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)

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