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

Organon

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Dietary Supplement: Comparator: Vitamin D; Drug: Comparator: alendronate; Drug: alendronate sodium+vitamin D combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803790

2008_595

0217A-253

Details and patient eligibility

About

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.

Enrollment: 318 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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318 participants in 4 patient groups

Sequence 1- alendronate+vitamin D combination then alendronate

Experimental group

Description:

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.

Treatment:

Drug: Comparator: alendronate

Drug: alendronate sodium+vitamin D combination

Sequence 2 alendronate then alendronate+vitamin D combination

Experimental group

Description:

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.

Treatment:

Drug: Comparator: alendronate

Drug: alendronate sodium+vitamin D combination

Sequence 3 alendronate+vitamin D combination then vitamin D

Experimental group

Description:

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.

Treatment:

Drug: alendronate sodium+vitamin D combination

Dietary Supplement: Comparator: Vitamin D

Sequence 4- vitamin D then alendronate+vitamin D combination

Experimental group

Description:

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.

Treatment:

Drug: alendronate sodium+vitamin D combination

Dietary Supplement: Comparator: Vitamin D