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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00518531 |
Purpose
The primary objective is to evaluate the adherence of subjects to SC 60 mg denosumab Q6M treatment compared to oral 70 mg alendronate QW treatment at the end of treatment period 1 (12 months).
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: denosumab Drug: alendronate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Randomized, Cross-Over, Open-label Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Alendronate in Postmenopausal Women With Low Bone Mineral Density |
| Estimated Enrollment: | 250 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment Sequence B
When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC for 1 year (Treatment Period 2).
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Drug: denosumab
Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1.
Drug: alendronate
Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1.
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Treatment Sequence A
When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment sequences. Subjects randomized to treatment sequence A will receive 60 mg denosumab Q6M SC for 1-year (Treatment period 1) followed by oral alendronate 70 mg QW for 1 year (Treatment period 2).
|
Drug: denosumab
Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1.
Drug: alendronate
Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1.
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindicated to alendronate therapy; contraindications for alendronate therapy include:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Research Site | |
| Mesa, Arizona, United States | |
| United States, California | |
| Research Site | |
| San Diego, California, United States | |
| United States, Connecticut | |
| Research Site | |
| Waterbury, Connecticut, United States | |
| Research Site | |
| Hamden, Connecticut, United States | |
| United States, Florida | |
| Research Site | |
| Jupiter, Florida, United States | |
| Research Site | |
| Longwood, Florida, United States | |
| Research Site | |
| Leesburg, Florida, United States | |
| United States, Illinois | |
| Research Site | |
| Arlington Heights, Illinois, United States | |
| United States, Indiana | |
| Research Site | |
| Muncie, Indiana, United States | |
| United States, Kentucky | |
| Research Site | |
| Louisville, Kentucky, United States | |
| United States, North Carolina | |
| Research Site | |
| New Bern, North Carolina, United States | |
| United States, North Dakota | |
| Research Site | |
| Bismarck, North Dakota, United States | |
| Research Site | |
| Fargo, North Dakota, United States | |
| United States, Oklahoma | |
| Research Site | |
| Stillwater, Oklahoma, United States | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States | |
| Research Site | |
| Medford, Oregon, United States | |
| United States, Pennsylvania | |
| Research Site | |
| West Reading, Pennsylvania, United States | |
| United States, South Dakota | |
| Research Site | |
| Watertown, South Dakota, United States | |
| United States, Texas | |
| Research Site | |
| Amarillo, Texas, United States | |
| Research Site | |
| San Antonio, Texas, United States | |
| Research Site | |
| Houston, Texas, United States | |
| Research Site | |
| Katy, Texas, United States | |
| Research Site | |
| Carrollton, Texas, United States | |
| Canada, British Columbia | |
| Research Site | |
| Vancouver, British Columbia, Canada | |
| Canada, Nova Scotia | |
| Research Site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Research Site | |
| Windsor, Ontario, Canada | |
| Research Site | |
| Hamilton, Ontario, Canada | |
| Canada, Quebec | |
| Research Site | |
| Montreal, Quebec, Canada | |
| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20060232, DAPS |
| Study First Received: | August 16, 2007 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00518531 History of Changes |
| Health Authority: | Canada: Health Canada; Canada: Institutional Review Board; United States: Food and Drug Administration; United States: Institutional Review Board |
|
osteoporosis low bone mineral density alendronate denosumab adherence |
preference satisfaction postmenopausal women |
|
Musculoskeletal Diseases Alendronate Physiological Effects of Drugs Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |