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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: alendronate sodium (+) cholecalciferol (Drug); Comparator: Placebo (unspecified) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter 4-Week Study to Assess the Effect of Alendronate 70 mg and Vitamin D3 2800 IU Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Detailed description: Placebo will be administered over a 4 week, single-blind run-in phase. Calcium, as citrate-malate, will be administered throughout the study at an individualized dose supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg. At the end of the stabilization period, baseline calcium absorption will be determined and patients will be randomized to receive either MK0217A, or matching placebo once weekly for 4 weeks.

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Female.

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

Locations and Contacts

Additional Information

Starting date: May 2004
Last updated: December 24, 2014

Page last updated: August 20, 2015

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