| August 16, 2007 |
| September 24, 2009 |
| September 2007 |
| July 2010 (final data collection date for primary outcome measure) |
| Proportion of subjects adherent to treatment at the end of treatment period 1. [ Time Frame: One year ] [ Designated as safety issue: No ] |
| Proportion of subjects adherent to treatment at the end of treatment period 1. |
| Complete list of historical versions of study NCT00518531 on ClinicalTrials.gov Archive Site |
- Proportion of subjects adherent to treatment at the end of treatment period 2. [ Time Frame: Two year ] [ Designated as safety issue: No ]
- Proportion of subjects compliant to treatment at the end of each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
- Proportion of subjects persisting with treatment at the end of each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
- Time to treatment non-adherence (weeks) with 70 mg alendronate QW in each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
- Time to treatment non-compliance (weeks) with 70 mg alendronate QW in each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
- Time to treatment non-persistence (weeks) with 70 mg alendronate QW in each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
- Subject preference to treatment at the end of treatment period 2. [ Time Frame: Measured at the end of treatment period 2 (2 years) ] [ Designated as safety issue: No ]
- Proportion of subjects satisfied with treatment at the end of each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
- BMQ scores and MARS scores during each treatment period. [ Time Frame: Measured during each treatment period ] [ Designated as safety issue: No ]
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- Proportion of subjects adherent to treatment at the end of treatment period 2.
- Proportion of subjects compliant to treatment at the end of each treatment period.
- Proportion of subjects persisting with treatment at the end of each treatment period.
- Time to treatment non-adherence (weeks) with 70 mg alendronate QW in each treatment period.
- Time to treatment non-compliance (weeks) with 70 mg alendronate QW in each treatment period.
- Time to treatment non-persistence (weeks) with 70 mg alendronate QW in each treatment period.
- Subject preference to treatment at 18 months and at the end of treatment period 2.
- Proportion of subjects satisfied with treatment at the end of each treatment period.
- BMQ scores and MARS scores at six months and at teh end of each treatment period and changes in scores.
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| Denosumab Adherence Preference Satisfaction Study |
| 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 |
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). |
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| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
| Osteoporosis |
- Drug: denosumab
- Drug: alendronate
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- Other: 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).
- Other: 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).
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| |
| Active, not recruiting |
| 250 |
| November 2010 |
| July 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Ambulatory postmenopausal women based on medical history
- > or = 55 years of age at the start of screening
- Screening BMD values (g/cm²), at the lumbar spine OR femoral neck OR total hip that occur within the specified ranges based on the particular scanner that is used. At least 2 lumbar vertebrae must be evaluable by DXA, or at least one hip must be evaluable by DXA
- Provide written informed consent before any study specific procedure is performed.
Exclusion Criteria:
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| Female |
| 55 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00518531 |
| Global Development Leader, Amgen Inc. |
| 20060232, DAPS |
| Amgen |
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| Amgen |
| September 2009 |