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

21:47 EDT 31st October 2014 | 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

Clinical Trials [1362 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis

To demonstrate the efficacy/safety of Fosamax Plus D

MK5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate

This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be achieved by switching to MK5442 from an oral bisphosphonate in patients who have been receiving or...

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density, improve biochemical markers of bone turnover, and reduce the number of falls as com...

Upper GI Handling of Branded vs. Generic Alendronate

To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side ef...

The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients

Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to examine whether alendronate in combination with calcium and vitamin D is safe and effective for tr...

PubMed Articles [2960 Associated PubMed Articles listed on BioPortfolio]

Efficacy and Safety of Weekly Alendronate Plus Vitamin D₃ 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial.

Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly...

A fast and simple spectrofluorometric method for the determination of alendronate sodium in pharmaceuticals.

Introduction: Alendronate sodium enhances bone formation and increases osteoblast proliferation and maturation and leads to the inhibition of osteoblast apoptosis. Therefore, a rapid and simple spectr...

Activation of FGF-23 Mediated Vitamin D Degradative Pathways by Cholecalciferol.

Context: The optimal circulating concentration of 25(OH) vitamin D is controversial. Objective: To investigate if FGF-23 and 24,25(OH)2D can guide cholecalciferol replacement. Design: Oral cholecalcif...

Oral postdialysis cholecalciferol supplementation in patients on maintenance hemodialysis: a dose-response approach.

The aim of the present study was to evaluate the dose of postdialysis cholecalciferol needed to maintain the 25-hydroxyvitamin D [25(OH)D] levels in the optimal range of 75-150 nmol/L. Twenty-six pa...

Pharmacokinetics of daily versus monthly vitamin D3 supplementation in non-lactating women.

This study compared serum cholecalciferol and 25-hydroxyvitamin D (25(OH)D) concentrations over four weeks in healthy, non-pregnant, non-lactating females aged 18-40 years, who were randomized to oral...

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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