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Completed

NCT Number: NCT01575834

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

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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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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

Treatment and study plan

Romosozumab

Drug

Administered by subcutaneous injection once a month (QM)

Other names: AMG 785, EVENITY™

Placebo

Drug

Administered by subcutaneous injection once a month (QM)

Denosumab

Drug

Administered by subcutaneous injection once every 6 months (Q6M)

Other names: Prolia®

Primary outcomes

  1. Percentage of Participants With New Vertebral Fracture Through Month 12

    Time frame: 12 Months

    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.

  2. Percentage of Participants With New Vertebral Fracture Through Month 24

    Time frame: 24 months

    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.

Secondary outcomes

  1. Percentage of Participants With a Clinical Fracture Through Month 12

    Time frame: 12 Months

    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.

  2. Percentage of Participants With a Nonvertebral Fracture Through Month 12

    Time frame: 12 Months

    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.

  3. Percentage of Participants With a Nonvertebral Fracture Through Month 24

    Time frame: 24 Months

    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.

  4. Percentage of Participants With a Clinical Fracture Through Month 24

    Time frame: 24 Months

    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.

  5. Percentage of Participants With a Major Nonvertebral Fracture Through Month 12

    Time frame: 12 Months

    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.

  6. Percentage of Participants With a Major Nonvertebral Fracture Through Month 24

    Time frame: 24 Months

    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.

  7. Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12

    Time frame: 12 Months

    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.

  8. Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24

    Time frame: 24 Months

    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.

  9. Percentage of Participants With a Hip Fracture Through Month 12

    Time frame: 12 Months

    Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

  10. Percentage of Participants With a Hip Fracture Through Month 24

    Time frame: 24 Months

    Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

  11. Percentage of Participants With a Major Osteoporotic Fracture Through Month 12

    Time frame: 12 Months

    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.

  12. Percentage of Participants With a Major Osteoporotic Fracture Through Month 24

    Time frame: 24 Months

    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.

  13. Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12

    Time frame: 12 Months

    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.

  14. Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24

    Time frame: 24 Months

    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.

  15. Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

    Time frame: Baseline and Month 12

    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

  16. Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24

    Time frame: Baseline and Month 24

    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

  17. Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12

    Time frame: Baseline and Month 12

    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

  18. Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24

    Time frame: Baseline and Month 24

    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

  19. Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12

    Time frame: Baseline and Month 12

    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

  20. Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24

    Time frame: Baseline and Month 24

    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Acronym: FRAME

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 12, 2012
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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