Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women

To demonstrate the efficacy/safety of Fosamax Plus D

Inclusion Criteria:

• Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
• Patient has been diagnosed with osteoporosis
• Patient has been postmenopausal for more than 6 months
• Patient has no contraindication to taking oral bisphosphonates
• Patient is eligible for dual energy x-ray absorptiometry in spine or hip

Exclusion Criteria:

• Patients with esophageal dysfunction
• Patients who can not sit or stand at least 30 minutes
• Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
• Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
• Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months