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NCT Number: NCT00803790

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alendronate sodium+vitamin D combination

Drug

A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.

Comparator: alendronate

Drug

A single dose tablet of 70mg alendronate in one treatment period of each sequence.

Comparator: Vitamin D

Dietary Supplement

Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.

Primary outcomes

  1. Part 1: Urinary Excretion of Alendronate

    Time frame: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)

    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.

  2. Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D

    Time frame: Day 1 across the 80-hour plasma collection period (Period 1 and 2)

    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 outcomes

  1. Part II : Maximum Concentration (Cmax) of Vitamin D

    Time frame: Day 1 across the 80-hour plasma collection period (Periods 1 and 2)

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Dec 8, 2008
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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