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

23:49 EDT 26th May 2015 | 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 [1446 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

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...

Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis. II. Assess the safety and efficacy of this treatment...

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...

PubMed Articles [2760 Associated PubMed Articles listed on BioPortfolio]

Vitamin D production after UVB exposure - A comparison of exposed skin regions.

Cholecalciferol is an essential steroid produced in the skin by solar ultraviolet B radiation (UVB 290-315nm). Skin production of cholecalciferol depends on factors affecting UVB flux, age and exposed...

The effect on quality of life of vitamin D administration for advanced cancer treatment (VIDAFACT study): protocol of a randomised controlled trial.

Vitamin D is related to resistance to chronic diseases, physiological parameters and functional measures. All of these relationships underscore the potential benefits of cholecalciferol or D3 (nutriti...

Vitamin D Supplementation Blocks Pulmonary Structural and Functional Changes in a Rat Model of Perinatal Vitamin D deficiency.

Whereas epidemiologic data strongly link vitamin D (VD) deficiency to childhood asthma, the underlying molecular mechanisms remain unknown. Although VD is known to stimulate alveolar epithelial-mesenc...

Quantitative computed tomographic assessment of bone mineral density changes associated with administration of prednisolone or prednisolone and alendronate sodium in dogs.

OBJECTIVE To evaluate whether a low-dosage regimen of prednisolone induces bone loss and whether administration of alendronate sodium prevents glucocorticoid-induced osteopenia in dogs by measuring tr...

The Carcinogenicity of Alendronate in Patients with Osteoporosis: Evidence from Cohort Studies.

Alendronate may relate to the incidence of cancers, especially esophageal and colon cancer. But the results are inconsistent in different studies.

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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