Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 318
Healthy volunteers: yes

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:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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.

Interventions: intervention 1: alendronate sodium+vitamin D combination intervention 2: Comparator: alendronate intervention 3: Comparator: Vitamin D
Intervention descriptions: intervention 1: A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence. intervention 2: A single dose tablet of 70mg alendronate in one treatment period of each sequence. intervention 3: Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.

Protocol document: