Phase 1
Completed N=318
A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)
Source: ClinicalTrials.gov NCT00803790 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Part 1: Urinary Excretion of Alendronate — 133.6; 132.2 μg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Urinary Excretion of Alendronate |
133.6; 132.2 | — |
| PRIMARY Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D |
490.2; 518.7 | — |
| SECONDARY Part II : Maximum Concentration (Cmax) of Vitamin D |
12.2; 13.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00803790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.