A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

Phase 3CompletedNCT00092027

Organon and Co454 enrolled

Overview

This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

454

Conditions

Postmenopausal Osteoporosis

Interventions

MK0217, alendronate sodium/Duration of Treatment: 6 monthsDRUG

Comparator: placebo / Duration of Treatment: 6 monthsDRUG

Eligibility

Sex: FEMALEMin age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women with postmenopausal osteoporosis Exclusion Criteria: * High risk for fractures * Esophageal abnormalities * Upper gastrointestinal symptoms that are not relieved with medication * Metabolic bone disease (example - vitamin D deficiency) * Medications that would affect the breakdown or build-up of bone

Outcomes

Primary Outcomes

To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis

Secondary Outcomes

To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo

To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months

Data from ClinicalTrials.gov

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