Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis Postmenopausal
Intervention: alendronate sodium (+) cholecalciferol (Drug); Comparator: Alendronate sodium (Fosamax) (Drug); Comparator: Calcium (Dietary Supplement)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
To demonstrate the efficacy/safety of Fosamax Plus D
Clinical Details
Official title: A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
Secondary outcome: Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: March 2008
Last updated: July 21, 2015
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