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

Organon

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Comparator: placebo / Duration of Treatment: 6 months; Drug: MK0217, alendronate sodium/Duration of Treatment: 6 months

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092027

0217-219

2004_017

MK0217-219

Details and patient eligibility

About

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

Enrollment: 454 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind