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

• Status: Completed
• Trial end date: 2009-04-10
• Target enrollment: 0
• Participant gender: Female

Summary

To demonstrate the efficacy/safety of Fosamax Plus D

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Alendronate; Calcium; Cholecalciferol

Criteria

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