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

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: alendronate sodium+vitamin D combination

• Registration Number: NCT00803790
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Results First Submitted: 2011-01-27
• Results First Submitted QC: 2011-04-14
• Results First Posted: 2011-05-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1- alendronate+vitamin D combination then alendronate	alendronate sodium+vitamin D combination	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.
Sequence 2 alendronate then alendronate+vitamin D combination	alendronate sodium+vitamin D combination	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.
Sequence 3 alendronate+vitamin D combination then vitamin D	alendronate sodium+vitamin D combination	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.
Sequence 4- vitamin D then alendronate+vitamin D combination	alendronate sodium+vitamin D combination	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.

Primary Outcome Measures

Name	Time	Method
Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D	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.
Part 1: Urinary Excretion of Alendronate	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.

Secondary Outcome Measures

Name	Time	Method
Part II : Maximum Concentration (Cmax) of Vitamin D	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.