The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
7,180
Administered by subcutaneous injection once a month (QM)
Administered by subcutaneous injection once a month (QM)
Administered by subcutaneous injection once every 6 months (Q6M)
Percentage of Participants With New Vertebral Fracture Through Month 12
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method. The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Time frame: 12 Months
Percentage of Participants With New Vertebral Fracture Through Month 24
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method. The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Time frame: 24 months
Percentage of Participants With a Clinical Fracture Through Month 12
Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
Time frame: 12 Months
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Research Site
Tucson, Arizona, United States
Research Site
Laguna Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
Santa Maria, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Lakewood, Colorado, United States
Research Site
Leesburg, Florida, United States
Research Site
Palm Harbor, Florida, United States
Research Site
Plantation, Florida, United States
...and 208 more locations
Percentage of Participants With a Nonvertebral Fracture Through Month 12
A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
Time frame: 12 Months
Percentage of Participants With a Nonvertebral Fracture Through Month 24
A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date as recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
Time frame: 24 Months
Percentage of Participants With a Clinical Fracture Through Month 24
Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
Time frame: 24 Months
Percentage of Participants With a Major Nonvertebral Fracture Through Month 12
A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.
Time frame: 12 Months
Percentage of Participants With a Major Nonvertebral Fracture Through Month 24
A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.
Time frame: 24 Months
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12
A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.
Time frame: 12 Months
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.
Time frame: 24 Months
Percentage of Participants With a Hip Fracture Through Month 12
Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
Time frame: 12 Months
Percentage of Participants With a Hip Fracture Through Month 24
Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
Time frame: 24 Months
Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.
Time frame: 12 Months
Percentage of Participants With a Major Osteoporotic Fracture Through Month 24
Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.
Time frame: 24 Months
Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12
A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.
Time frame: 12 Months
Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.
Time frame: 24 Months
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time frame: Baseline and Month 12
Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time frame: Baseline and Month 24
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time frame: Baseline and Month 12
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time frame: Baseline and Month 24
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time frame: Baseline and Month 12
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time frame: Baseline and Month 24