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A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D

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ClinicalTrials.gov Identifier: NCT00806416
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : February 12, 2010
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief Summary:
This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: alendronate sodium (+) cholecalciferol Drug: Comparator: alendronate Dietary Supplement: Comparator: cholecalciferol (Vitamin D) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70 mg Alendronate/2800 IU Vitamin D3 Final Market Combination Tablet to a 70 mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3
Study Start Date : May 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence 1
alendronate/vitamin D combination then alendronate
 Drug: alendronate sodium (+) cholecalciferol
A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

Drug: Comparator: alendronate
A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
Experimental: Sequence 2
alendronate then alendronate/vitamin D combination
 Drug: alendronate sodium (+) cholecalciferol
A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

Drug: Comparator: alendronate
A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
Experimental: Sequence 3
alendronate/vitamin D combination then vitamin D
 Drug: alendronate sodium (+) cholecalciferol
A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

Dietary Supplement: Comparator: cholecalciferol (Vitamin D)
A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
Experimental: Sequence 4
vitamin D then alendronate/vitamin D combination
 Drug: alendronate sodium (+) cholecalciferol
A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

Dietary Supplement: Comparator: cholecalciferol (Vitamin D)
A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet [ Time Frame: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2). ]
    Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. 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.

  2. Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet [ Time Frame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2). ]

    Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.

    Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.


  3. Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet [ Time Frame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2). ]
    Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or nonpregnant female age 18 to 65 years
  • Female of childbearing potential on appropriate method of contraception and not nursing
  • BMI (body mass index) less than or equal to 30 kg/m2
  • Subject is in good health
  • Willing to limit direct sunlight and apply sunscreen if in the sun more than 1 hour

Exclusion Criteria:

  • mental or legal incapacitation
  • received bisphosphonate treatment within 3 months of screening
  • unable to sit or stand upright for at least 2 hours
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806416


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00806416    
Other Study ID Numbers: 0217A-226
2008_596
First Posted: December 10, 2008    Key Record Dates
Results First Posted: February 12, 2010
Last Update Posted: February 8, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Cholecalciferol
 Alendronate
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents