Overview

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