4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Alendronate; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• The patient is a postmenopausal osteoporotic female

• The patient is willing to limit direct sunlight exposure during the course of the study

• The patient must be ambulatory

• The patient has serum 25-hydroxyvitamin D =25 ng/mL

Exclusion Criteria:

• The patient is contraindicated to bisphosphonate therapy

• The patient has a vitamin D deficiency

• Patient will be excluded if their weight is above 85 kg

• The patient has a history of prior osteoporotic fracture

• The patient is currently or has received in the past treatment with effects on bone or calcium metabolism

• The patient has malabsorption syndrome

• The patient has active thyroid disease

• The patient has metabolic bone disease

• The patient had a myocardial infarction within 6 months of screening visit

• The patient has impaired renal function

• The patient is currently or has been a smoker in the last year