Overview

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