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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01575834
Registration number
NCT01575834
Ethics application status
Date submitted
4/04/2012
Date registered
12/04/2012
Date last updated
28/05/2024
Titles & IDs
Public title
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
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Scientific title
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
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Secondary ID [1]
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0
2011-001456-11
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Secondary ID [2]
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20070337
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Universal Trial Number (UTN)
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Trial acronym
FRAME
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Osteoporosis
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0
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Condition category
Condition code
Musculoskeletal
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0
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Osteoporosis
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Reproductive Health and Childbirth
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0
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0
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Romosozumab
Treatment: Drugs - Placebo
Treatment: Drugs - Denosumab
Experimental: Romosozumab - Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Placebo Comparator: Placebo - Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Treatment: Drugs: Romosozumab
Administered by subcutaneous injection once a month (QM)
Treatment: Drugs: Placebo
Administered by subcutaneous injection once a month (QM)
Treatment: Drugs: Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With New Vertebral Fracture Through Month 12
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Assessment method [1]
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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.
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Timepoint [1]
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12 Months
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Primary outcome [2]
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Percentage of Participants With New Vertebral Fracture Through Month 24
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Assessment method [2]
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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.
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Timepoint [2]
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24 months
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Secondary outcome [1]
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Percentage of Participants With a Clinical Fracture Through Month 12
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Assessment method [1]
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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.
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Timepoint [1]
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12 Months
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Secondary outcome [2]
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Percentage of Participants With a Nonvertebral Fracture Through Month 12
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Assessment method [2]
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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.
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Timepoint [2]
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12 Months
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Secondary outcome [3]
0
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Percentage of Participants With a Nonvertebral Fracture Through Month 24
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Assessment method [3]
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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.
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Timepoint [3]
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24 Months
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Secondary outcome [4]
0
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Percentage of Participants With a Clinical Fracture Through Month 24
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Assessment method [4]
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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.
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Timepoint [4]
0
0
24 Months
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Secondary outcome [5]
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Percentage of Participants With a Major Nonvertebral Fracture Through Month 12
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Assessment method [5]
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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.
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Timepoint [5]
0
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12 Months
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Secondary outcome [6]
0
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Percentage of Participants With a Major Nonvertebral Fracture Through Month 24
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Assessment method [6]
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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.
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Timepoint [6]
0
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24 Months
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Secondary outcome [7]
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Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12
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Assessment method [7]
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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.
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Timepoint [7]
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12 Months
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Secondary outcome [8]
0
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Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
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Assessment method [8]
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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.
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Timepoint [8]
0
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24 Months
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Secondary outcome [9]
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Percentage of Participants With a Hip Fracture Through Month 12
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Assessment method [9]
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Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
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Timepoint [9]
0
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12 Months
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Secondary outcome [10]
0
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Percentage of Participants With a Hip Fracture Through Month 24
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Assessment method [10]
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Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
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Timepoint [10]
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24 Months
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Secondary outcome [11]
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Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
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Assessment method [11]
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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.
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Timepoint [11]
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12 Months
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Secondary outcome [12]
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Percentage of Participants With a Major Osteoporotic Fracture Through Month 24
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Assessment method [12]
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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.
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Timepoint [12]
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24 Months
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Secondary outcome [13]
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Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12
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Assessment method [13]
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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.
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Timepoint [13]
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12 Months
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Secondary outcome [14]
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Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
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Assessment method [14]
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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.
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Timepoint [14]
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24 Months
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Secondary outcome [15]
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Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
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Assessment method [15]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [15]
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Baseline and Month 12
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Secondary outcome [16]
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Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24
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Assessment method [16]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [16]
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Baseline and Month 24
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Secondary outcome [17]
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Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12
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Assessment method [17]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [17]
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Baseline and Month 12
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Secondary outcome [18]
0
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Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
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Assessment method [18]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [18]
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Baseline and Month 24
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Secondary outcome [19]
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Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12
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Assessment method [19]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [19]
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Baseline and Month 12
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Secondary outcome [20]
0
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Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24
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Assessment method [20]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [20]
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Baseline and Month 24
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Eligibility
Key inclusion criteria
- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score
at the total hip or femoral neck of = -2.50)
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Minimum age
55
Years
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Maximum age
90
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- BMD T-score of = -3.50 at the total hip or femoral neck
- History of hip fracture
- Any severe or more than 2 moderate vertebral fractures, as assessed by the central
imaging based on lateral spine x-rays
- Use of agents affecting bone metabolism
- History of metabolic or bone disease (except osteoporosis)
- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/12/2016
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Sample size
Target
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Accrual to date
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Final
7180
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Maroubra
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Recruitment hospital [2]
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Research Site - St Leonards
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Recruitment hospital [3]
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Research Site - Herston
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Recruitment hospital [4]
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Research Site - Keswick
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Recruitment hospital [5]
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Research Site - Footscray
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Recruitment hospital [6]
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Research Site - Geelong
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Recruitment hospital [7]
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Research Site - Heidelberg West
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Recruitment hospital [8]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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5035 - Keswick
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Recruitment postcode(s) [5]
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3011 - Footscray
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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3081 - Heidelberg West
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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New Mexico
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North Carolina
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North Dakota
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Ohio
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Texas
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Argentina
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Argentina
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Córdoba
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Bruxelles
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Genk
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Liège
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Lommel
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São Paulo
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Brno
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Plzen
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Uherske Hradiste
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Zlin
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Aalborg
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Odense
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Vejle
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Pärnu
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Tallinn
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Tartu
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Germany
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Berlin (Hellersdorf)
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dresden
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Germany
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Frankfurt am Main
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Germany
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Görlitz
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Hannover
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Heinsberg
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Germany
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Leipzig
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Funding & Sponsors
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Summary
Brief summary
The purpose of this study is to determine if treatment with romosozumab is effective in
preventing fractures in women with postmenopausal osteoporosis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01575834
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Trial related presentations / publications
Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.
Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17.
Chavassieux P, Chapurlat R, Portero-Muzy N, Roux JP, Garcia P, Brown JP, Libanati C, Boyce RW, Wang A, Grauer A. Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment. J Bone Miner Res. 2019 Sep;34(9):1597-1608. doi: 10.1002/jbmr.3735. Epub 2019 Jun 24.
Cosman F, Crittenden DB, Ferrari S, Lewiecki EM, Jaller-Raad J, Zerbini C, Milmont CE, Meisner PD, Libanati C, Grauer A. Romosozumab FRAME Study: A Post Hoc Analysis of the Role of Regional Background Fracture Risk on Nonvertebral Fracture Outcome. J Bone Miner Res. 2018 Aug;33(8):1407-1416. doi: 10.1002/jbmr.3439. Epub 2018 May 11.
Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3.
Miyauchi A, Dinavahi RV, Crittenden DB, Yang W, Maddox JC, Hamaya E, Nakamura Y, Libanati C, Grauer A, Shimauchi J. Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension. Arch Osteoporos. 2019 Jun 5;14(1):59. doi: 10.1007/s11657-019-0608-z.
Miyauchi A, Hamaya E, Yang W, Nishi K, Libanati C, Tolman C, Shimauchi J. Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial. J Bone Miner Metab. 2021 Mar;39(2):278-288. doi: 10.1007/s00774-020-01147-5. Epub 2020 Oct 15.
McCloskey EV, Johansson H, Harvey NC, Lorentzon M, Shi Y, Kanis JA. Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study. Osteoporos Int. 2021 Aug;32(8):1601-1608. doi: 10.1007/s00198-020-05815-0. Epub 2021 Feb 3.
Eriksen EF, Chapurlat R, Boyce RW, Shi Y, Brown JP, Horlait S, Betah D, Libanati C, Chavassieux P. Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial. J Bone Miner Res. 2022 Jan;37(1):36-40. doi: 10.1002/jbmr.4457. Epub 2021 Nov 19.
Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.
Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9. Erratum In: J Bone Miner Metab. 2020 Mar 20;:
Miyauchi A, Hamaya E, Nishi K, Tolman C, Shimauchi J. Efficacy and safety of romosozumab among Japanese postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease. J Bone Miner Metab. 2022 Jul;40(4):677-687. doi: 10.1007/s00774-022-01332-8. Epub 2022 May 31.
Eriksen EF, Boyce RW, Shi Y, Brown JP, Betah D, Libanati C, Oates M, Chapurlat R, Chavassieux P. Reconstruction of Remodeling units reveals positive effects after 2 and 12 months of Romosozumab treatment. J Bone Miner Res. 2024 Apr 19:zjae055. doi: 10.1093/jbmr/zjae055. Online ahead of print.
Lane NE, Betah D, Deignan C, Oates M, Wang Z, Timoshanko J, Khan AA, Binkley N. Effect of Romosozumab Treatment in Postmenopausal Women With Osteoporosis and Knee Osteoarthritis: Results From a Substudy of a Phase 3 Clinical Trial. ACR Open Rheumatol. 2024 Jan;6(1):43-51. doi: 10.1002/acr2.11619. Epub 2023 Nov 20.
McClung MR, Betah D, Deignan C, Shi Y, Timoshanko J, Cosman F. Romosozumab Efficacy in Postmenopausal Women With No Prior Fracture Who Fulfill Criteria for Very High Fracture Risk. Endocr Pract. 2023 Sep;29(9):716-722. doi: 10.1016/j.eprac.2023.06.011. Epub 2023 Jul 4.
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Public notes
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Contacts
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01575834
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