Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 244
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: alendronate/vitamin D combination then alendronate arm 2: alendronate then alendronate/vitamin D combination arm 3: alendronate/vitamin D combination then vitamin D arm 4: vitamin D then alendronate/vitamin D combination

Interventions: intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: alendronate intervention 3: Comparator: cholecalciferol (Vitamin D)
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol document: