Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00729651 |
To demonstrate the efficacy/safety of FOSAMAX PLUS D.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis Postmenopausal |
Drug: Alendronate sodium/Cholecalciferol (FOSAMAX Plus D) Drug: Alendronate sodium (FOSAMAX) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV (Phase V Program), Prospective, Randomized, Open-Label, Active-Controlled, Clinical Trial to Study the Efficacy and Safety of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis |
Estimated Enrollment: | 350 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Alendronate sodium/Cholecalciferol
|
Drug: Alendronate sodium/Cholecalciferol (FOSAMAX Plus D)
Alendronate sodium/Cholecalciferol ; tablet, once weekly, 16wks
|
2: Active Comparator
Alendronate sodium
|
Drug: Alendronate sodium (FOSAMAX)
Alendronate sodium ; tablet, once weekly, 16wks
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has been postmenopausal defined as
Patient meets one of the following:
Exclusion criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_015, MK217A-263 |
Study First Received: | August 5, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00729651 |
Health Authority: | Korea: Food and Drug Administration |
Cholecalciferol Musculoskeletal Diseases Alendronate Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |