Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Phase 4
Completed
- Conditions
- Osteoporosis Postmenopausal
- Interventions
- Registration Number
- NCT00729651
- Lead Sponsor
- Organon and Co
- Brief Summary
To demonstrate the efficacy/safety of Fosamax Plus D
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 343
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 alendronate sodium (+) cholecalciferol Alendronate sodium/Cholecalciferol
- Primary Outcome Measures
Name Time Method Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment 16 weeks
- Secondary Outcome Measures
Name Time Method Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment Baseline and 16 weeks