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

Organon

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Dietary Supplement: Comparator: cholecalciferol (Vitamin D); Drug: alendronate sodium (+) cholecalciferol; Drug: Comparator: alendronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806416

0217A-226

2008_596

Details and patient eligibility

About

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.

Enrollment: 244 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or nonpregnant female age 18 to 65 years
• Female of childbearing potential on appropriate method of contraception and not nursing
• BMI (body mass index) less than or equal to 30 kg/m2
• Subject is in good health
• Willing to limit direct sunlight and apply sunscreen if in the sun more than 1 hour

Exclusion criteria

• mental or legal incapacitation
• received bisphosphonate treatment within 3 months of screening
• unable to sit or stand upright for at least 2 hours

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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244 participants in 4 patient groups

Sequence 1

Experimental group

Description:

alendronate/vitamin D combination then alendronate

Treatment:

Drug: Comparator: alendronate

Drug: alendronate sodium (+) cholecalciferol

Sequence 2

Experimental group

Description:

alendronate then alendronate/vitamin D combination

Treatment:

Drug: Comparator: alendronate

Drug: alendronate sodium (+) cholecalciferol

Sequence 3

Experimental group

Description:

alendronate/vitamin D combination then vitamin D

Treatment:

Dietary Supplement: Comparator: cholecalciferol (Vitamin D)

Drug: alendronate sodium (+) cholecalciferol

Sequence 4

Experimental group

Description:

vitamin D then alendronate/vitamin D combination

Treatment:

Dietary Supplement: Comparator: cholecalciferol (Vitamin D)

Drug: alendronate sodium (+) cholecalciferol