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

NCT ID: NCT00803790

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2006-07-31

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1- alendronate+vitamin D combination then alendronate

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.

Group Type: EXPERIMENTAL

alendronate sodium+vitamin D combination

Intervention Type: DRUG

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

Comparator: alendronate

Intervention Type: DRUG

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

Sequence 2 alendronate then alendronate+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.

Group Type: EXPERIMENTAL

alendronate sodium+vitamin D combination

Intervention Type: DRUG

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

Comparator: alendronate

Intervention Type: DRUG

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

Sequence 3 alendronate+vitamin D combination then vitamin D

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.

Group Type: EXPERIMENTAL

alendronate sodium+vitamin D combination

Intervention Type: DRUG

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

Comparator: Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

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

Sequence 4- vitamin D then alendronate+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.

Group Type: EXPERIMENTAL

alendronate sodium+vitamin D combination

Intervention Type: DRUG

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

Comparator: Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

alendronate sodium+vitamin D combination

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

Intervention Type: DRUG

Comparator: alendronate

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

Intervention Type: DRUG

Comparator: Vitamin D

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.

Reference Type: DERIVED

PMID: 21148044 (View on PubMed)

Other Identifiers

2008_595

Identifier Type: -

Identifier Source: secondary_id

0217A-253

Identifier Type: -

Identifier Source: org_study_id