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A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
alendronate sodium+vitamin D combination
Comparator: alendronate
Comparator: Vitamin D
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or nonpregnant female age 18 to 85 years
  • female of childbearing potential on appropriate method of contraception and not nursing
  • Body Mass Index (BMI) less than or equal to 30 kg/m2
  • subject is in good health

Exclusion Criteria:

  • mental or legal incapacitation
  • received bisphosphonate treatment within 3 months of enrollment.
  • unable to sit or stand upright for at least 2 hours
  • unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration
  • unwilling to limit alcohol consumption to no more than 2 drinks per day
  • unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent.
  • unwilling to refrain from smoking during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Sequence 1- alendronate+vitamin D combination then alendronate

    Sequence 2 alendronate then alendronate+vitamin D combination

    Sequence 3 alendronate+vitamin D combination then vitamin D

    Sequence 4- vitamin D then alendronate+vitamin D combination

    Arm Description

    Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.

    Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.

    Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.

    Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.

    Outcomes

    Primary Outcome Measures

    Part 1: Urinary Excretion of Alendronate
    Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.
    Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
    The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.

    Secondary Outcome Measures

    Part II : Maximum Concentration (Cmax) of Vitamin D
    Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.

    Full Information

    First Posted
    December 4, 2008
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00803790
    Brief Title
    A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)
    Official Title
    A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone. This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    318 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1- alendronate+vitamin D combination then alendronate
    Arm Type
    Experimental
    Arm Description
    Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
    Arm Title
    Sequence 2 alendronate then alendronate+vitamin D combination
    Arm Type
    Experimental
    Arm Description
    Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
    Arm Title
    Sequence 3 alendronate+vitamin D combination then vitamin D
    Arm Type
    Experimental
    Arm Description
    Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
    Arm Title
    Sequence 4- vitamin D then alendronate+vitamin D combination
    Arm Type
    Experimental
    Arm Description
    Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    alendronate sodium+vitamin D combination
    Intervention Description
    A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: alendronate
    Intervention Description
    A single dose tablet of 70mg alendronate in one treatment period of each sequence.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Comparator: Vitamin D
    Intervention Description
    Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.
    Primary Outcome Measure Information:
    Title
    Part 1: Urinary Excretion of Alendronate
    Description
    Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.
    Time Frame
    Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)
    Title
    Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
    Description
    The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
    Time Frame
    Day 1 across the 80-hour plasma collection period (Period 1 and 2)
    Secondary Outcome Measure Information:
    Title
    Part II : Maximum Concentration (Cmax) of Vitamin D
    Description
    Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
    Time Frame
    Day 1 across the 80-hour plasma collection period (Periods 1 and 2)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or nonpregnant female age 18 to 85 years female of childbearing potential on appropriate method of contraception and not nursing Body Mass Index (BMI) less than or equal to 30 kg/m2 subject is in good health Exclusion Criteria: mental or legal incapacitation received bisphosphonate treatment within 3 months of enrollment. unable to sit or stand upright for at least 2 hours unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration unwilling to limit alcohol consumption to no more than 2 drinks per day unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent. unwilling to refrain from smoking during the study
    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

    Citations:
    PubMed Identifier
    21148044
    Citation
    Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.
    Results Reference
    derived

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    A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)

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