| Primary | Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD) | Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm | Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG003 | MK-5442 10 mg | Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months. | | OG004 | Alendronate 70 mg | Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months. |
| | Units | Counts |
|---|
| Participants | - OG00081
- OG00182
- OG00279
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.36(-1.37 to 0.66)
- OG001-0.67(-1.67 to 0.33)
- OG002-0.52(-1.56 to 0.52)
- OG003
|
|
| | 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 |
|---|
| | Longitudinal Data Analysis Model | | 0.012 | The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided. | Difference in Least Squares Means | -1.96 | | | 2-Sided | 95 | -3.58 | -0.35 | | | | No | Superiority or Other | | | |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD | Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm | Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD | Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm | Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD | Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm | Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD | Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm | Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD | Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone. BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm | Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine | vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. | Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip | vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. | Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine | vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. | Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip | vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. | Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data). The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcomes analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx) | Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine. uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr | Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx) | C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml). | Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. | |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP) | s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml. | Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG003 |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) | Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L. | Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations. The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG003 |
|
| Secondary | Least Squares Mean Percent Change From Baseline to Month 12 in Serum Osteocalcin | Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL). | Analysis of osteocalcin was not conducted when it was determined that the efficacy of MK-5442 was not significantly different than placebo. | Posted | | | | | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG003 | MK-5442 10 mg | Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months. |
|
| Primary | Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once | Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L). Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a "Tier 1" adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons. | All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment. | Posted | | Number | | Participants | | Baseline through Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | |
|
| Primary | Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once | Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium). ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a "Tier 1" AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons). | All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment. | Posted | | Number | | Participants | | Baseline through Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. |
|
| Primary | Number of Participants With Predefined Tier 1 Adverse Events | Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons). | All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment. | Posted | | Number | | Participants | | Baseline through Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm. | | OG001 | MK-5442 5 mg | Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG002 | MK-5442 7.5 mg | Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months. | | OG003 | MK-5442 10 mg | |
|