Status:
COMPLETED
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Lead Sponsor:
Organon and Co
Conditions:
Osteoporosis Postmenopausal
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
To demonstrate the efficacy/safety of Fosamax Plus D
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2009
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT00729651
Start Date
March 20 2008
End Date
April 10 2009
Last Update
April 23 2024
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