| Primary | Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24 | BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24. | The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 24. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
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| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.73(0.61 to 2.85)
- OG001-0.94(-1.98 to 0.10)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value < 0.001). | Constrained longitudinal data analysis | | <0.001 | | Difference in the Least Squares Means | 2.67 | | | 2-Sided | 95 | 1.17 | 4.17 | | | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | | |
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| Primary | Percentage of Participants Experiencing One or More Adverse Events (AEs) | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. | The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took. | Posted | | Number | | Percentage of participants | | Up to 25 months | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Primary | Percentage of Participants Discontinuing Study Drug Due to an AE | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. | The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took. | Posted | | Number | | Percentage of participants | | Up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 12 | BMD at the femoral neck was assessed by DXA at baseline and Month 12. | The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 12. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Trochanter BMD at Month 24 | BMD at the trochanter was assessed by DXA at baseline and Month 24. | The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 24. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 24 Months | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Trochanter BMD at Month 12 | BMD at the trochanter was assessed by DXA at baseline and Month 12. | The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 12. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 12 Months | | | | ID | Title | Description |
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| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Total Hip BMD at Month 24 | BMD at the total hip was assessed by DXA at baseline and Month 24. | The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 24. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 24 Months | | | | ID | Title | Description |
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| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 | BMD at the total hip was assessed by DXA at baseline and Month 12. | The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 12. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 24 | BMD at the lumbar spine was assessed by DXA at baseline and Month 24. | The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 24. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 24 Months | | | | ID | Title | Description |
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| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | BMD at the lumbar spine was assessed by DXA at baseline and Month 12. | The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 12. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 12 Months | | | | ID | Title | Description |
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| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24 | BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24. | The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 24. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 24 Months | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12 | BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12. | The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 12. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and 12 Months | | | | ID | Title | Description |
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| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24 | s-CTx is a biochemical marker of bone resorption. | The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed s-CTx at Month 12 | s-CTx is a biochemical marker of bone resorption. | The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24 | N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption. | The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12 | u-NTx/Cr is a biochemical marker of bone resorption. | The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24 | Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation. | The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12 | BSAP is a biochemical marker of bone formation. | The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24 | Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation. | The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12 | s-P1NP is a biochemical marker of bone formation. | The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24 | Serum calcium is an index of calcium homeostasis. | The population analyzed included all randomized, treated participants who had serum calcium data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24 | Serum phosphate is an index of mineral homeostasis. | The population analyzed included all randomized, treated participants who had serum phosphate data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24 | Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood. | The population analyzed included all randomized, treated participants who had SPH data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24 | 1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine. | The population analyzed included all randomized, treated participants who had 1,25(OH)2 D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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| Secondary | Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24 | The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite. | The population analyzed included all randomized, treated participants who had 25(OH)D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Odanacatib 50 mg | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | | OG001 | Placebo | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
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