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A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D

2014-08-27 03:25:43 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Osteoporosis

Intervention

alendronate sodium (+) cholecalciferol, Comparator: alendronate, Comparator: cholecalciferol (Vitamin D)

Status

Completed

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:43-0400

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Medical and Biotech [MESH] Definitions

Hydroxy analogs of vitamin D 3; (CHOLECALCIFEROL); including CALCIFEDIOL; CALCITRIOL; and 24,25-DIHYDROXYVITAMIN D 3.

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

Derivatives of ERGOSTEROL formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. They differ from CHOLECALCIFEROL in having a double bond between C22 and C23 and a methyl group at C24.

Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.

A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.

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