At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 244 enrolled

Drug / intervention

alendronate sodium (+) cholecalciferol +2 moredrug

Likely dose

alendronate sodium (+) cholecalciferol 70 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00806416

NCT00806416Phase 1Completed

Compare CT.gov

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

Organon and Co·interventional·Posted Dec 10, 2008·Updated Feb 8, 2022

In Brief

A Phase 1 clinical trial evaluating alendronate sodium (+) cholecalciferol, Comparator: alendronate, and 1 other intervention for Osteoporosis. Completed, enrolled 244 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOsteoporosis

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2003

Primary CompletionAug 2003

Study CompletionJan 2004

First PostedDec 2008

TodayJul 2026

First PostedDec 10, 2008

Enrollment StartMay 1, 2003

Primary CompletionAug 1, 2003

Study CompletionJan 1, 2004

TodayJul 2, 2026

Enrollment to primary: 3 monthsPosted 17.6 years ago

Interventions

alendronate sodium (+) cholecalciferoldrug

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.

Comparator: alendronatedrug

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.

Comparator: cholecalciferol (Vitamin D)dietary

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.