Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)

January 30, 2024 updated by: Amgen

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

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Research Site
      • Buenos Aires, Argentina, C1425ACG
        • Research Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1015ABO
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1430CKE
        • Research Site
      • Mar del Plata, Buenos Aires, Argentina, B7600DHK
        • Research Site
    • Córdoba
      • Cordoba, Córdoba, Argentina, X5000BNB
        • Research Site
  • Australia
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • Research Site
      • St Leonards, New South Wales, Australia, 2065
        • Research Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Research Site
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • Research Site
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Research Site
      • Geelong, Victoria, Australia, 3220
        • Research Site
      • Heidelberg West, Victoria, Australia, 3081
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Research Site
  • Belgium
      • Bruxelles, Belgium, 1000
        • Research Site
      • Genk, Belgium, 3600
        • Research Site
      • Ghent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4020
        • Research Site
      • Lommel, Belgium, 3920
        • Research Site
      • Yvoir, Belgium, 5530
        • Research Site
  • Brazil
      • São Paulo, Brazil, 04266-010
        • Research Site
      • São Paulo, Brazil, 05403-000
        • Research Site
      • São Paulo, Brazil, 05437-010
        • Research Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Research Site
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 04063-001
        • Research Site
  • Canada
      • Quebec, Canada, G1V 3M7
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Research Site
      • Oakville, Ontario, Canada, L6M 1M1
        • Research Site
    • Quebec
      • Lachine, Quebec, Canada, H8S 2E4
        • Research Site
  • Colombia
      • Bogota, Colombia, 11001000
        • Research Site
    • Antioquia
      • Medellin, Antioquia, Colombia, 050021
        • Research Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 08001000
        • Research Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 11001000
        • Research Site
      • Bogota, Cundinamarca, Colombia
        • Research Site
      • Bogota, Cundinamarca, Colombia, 110221
        • Research Site
      • Bogota, Cundinamarca, Colombia, 1
        • Research Site
  • Czechia
      • Brno, Czechia, 602 00
        • Research Site
      • Ceske Budejovice, Czechia, 370 87
        • Research Site
      • Havlickuv Brod, Czechia, 580 22
        • Research Site
      • Klatovy, Czechia, 339 38
        • Research Site
      • Ostrava-Trebovice, Czechia, 722 00
        • Research Site
      • Pardubice, Czechia, 530 02
        • Research Site
      • Plzen, Czechia, 305 99
        • Research Site
      • Praha 11 - Chodov, Czechia, 148 00
        • Research Site
      • Praha 2, Czechia, 128 50
        • Research Site
      • Praha 3, Czechia, 130 00
        • Research Site
      • Uherske Hradiste, Czechia, 686 01
        • Research Site
      • Zlin, Czechia, 760 01
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Glostrup, Denmark, 2600
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
      • Odense, Denmark, 5000
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
      • Århus C, Denmark, 8000
        • Research Site
  • Dominican Republic
      • Santo Domingo, Dominican Republic, 10605
        • Research Site
    • Distrito Nacional
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10124
        • Research Site
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10514
        • Research Site
  • Estonia
      • Pärnu, Estonia, 80013
        • Research Site
      • Tallinn, Estonia, 10128
        • Research Site
      • Tartu, Estonia, 50410
        • Research Site
  • Germany
      • Berlin, Germany, 12200
        • Research Site
      • Berlin (Hellersdorf), Germany, 12627
        • Research Site
      • Bochum, Germany, 44787
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Dresden, Germany, 01067
        • Research Site
      • Frankfurt am Main, Germany, 60313
        • Research Site
      • Frankfurt am Main, Germany, 60528
        • Research Site
      • Görlitz, Germany, 02826
        • Research Site
      • Hamburg, Germany, 20354
        • Research Site
      • Hannover, Germany, 30167
        • Research Site
      • Heinsberg, Germany, 52525
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Magdeburg, Germany, 39120
        • Research Site
      • Marburg, Germany, 35043
        • Research Site
      • Schkeuditz, Germany, 04435
        • Research Site
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Research Site
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1027
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Gyor, Hungary, 9023
        • Research Site
      • Heviz, Hungary, 8380
        • Research Site
      • Szeged, Hungary, 6720
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 054
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Research Site
      • Pune, Maharashtra, India, 411 005
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302 019
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 020
        • Research Site
      • Vellore, Tamil Nadu, India, 632 004
        • Research Site
  • Japan
    • Aichi
      • Anjyo-shi, Aichi, Japan, 446-0063
        • Research Site
    • Chiba
      • Urayasu-shi, Chiba, Japan, 279-0004
        • Research Site
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-0005
        • Research Site
      • Fukui-shi, Fukui, Japan, 910-0067
        • Research Site
      • Fukui-shi, Fukui, Japan, 918-8057
        • Research Site
      • Fukui-shi, Fukui, Japan, 918-8236
        • Research Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 814-0111
        • Research Site
      • Fukutsu-shi, Fukuoka, Japan, 811-3217
        • Research Site
      • Kitakyushu-shi, Fukuoka, Japan, 806-0026
        • Research Site
      • Kurume-shi, Fukuoka, Japan, 830-0053
        • Research Site
      • Kurume-shi, Fukuoka, Japan, 839-0832
        • Research Site
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 733-0032
        • Research Site
    • Hokkaido
      • Chitose-shi, Hokkaido, Japan, 066-0062
        • Research Site
      • Ishikari-shi, Hokkaido, Japan, 061-3203
        • Research Site
      • Sunagawa-shi, Hokkaido, Japan, 073-0196
        • Research Site
    • Hyogo
      • Akashi-shi, Hyogo, Japan, 674-0051
        • Research Site
      • Kako-gun, Hyogo, Japan, 675-1115
        • Research Site
    • Ibaraki
      • Toride-shi, Ibaraki, Japan, 302-0022
        • Research Site
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-0015
        • Research Site
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-8538
        • Research Site
    • Kagoshima
      • Kirishima-shi, Kagoshima, Japan, 899-5102
        • Research Site
      • Minamikyusyu-shi, Kagoshima, Japan, 897-0215
        • Research Site
    • Kanagawa
      • Atugi-shi, Kanagawa, Japan, 243-0122
        • Research Site
      • Sagamihara-shi, Kanagawa, Japan, 252-5225
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 223-0062
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 223-0059
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 227-0064
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 231-0023
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 231-0861
        • Research Site
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 860-0066
        • Research Site
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 981-3213
        • Research Site
    • Nagano
      • Chiisagata-gun, Nagano, Japan, 386-0603
        • Research Site
      • Matsumoto-shi, Nagano, Japan, 390-1401
        • Research Site
      • Matsumoto-shi, Nagano, Japan, 390-8601
        • Research Site
      • Ueda-shi, Nagano, Japan, 386-0151
        • Research Site
      • Ueda-shi, Nagano, Japan, 386-0405
        • Research Site
    • Oita
      • Bungoono-shi, Oita, Japan, 879-7125
        • Research Site
    • Osaka
      • Osaka-shi, Osaka, Japan, 559-0011
        • Research Site
      • Takatsuki-shi, Osaka, Japan, 569-1123
        • Research Site
    • Saga
      • Saga-shi, Saga, Japan, 840-0027
        • Research Site
    • Saitama
      • Fujimi-shi, Saitama, Japan, 354-0021
        • Research Site
    • Shimane
      • Matsue-shi, Shimane, Japan, 699-0293
        • Research Site
    • Shizuoka
      • Fujinomiya-shi, Shizuoka, Japan, 418-0026
        • Research Site
      • Kikugawa-shi, Shizuoka, Japan, 439-0012
        • Research Site
    • Tokushima
      • Tokushima-Shi, Tokushima, Japan, 770-8503
        • Research Site
    • Tokyo
      • Hachioji-shi, Tokyo, Japan, 192-0046
        • Research Site
      • Kiyose-shi, Tokyo, Japan, 204-0021
        • Research Site
      • Minato-ku, Tokyo, Japan, 108-0075
        • Research Site
      • Ota-ku, Tokyo, Japan, 143-0015
        • Research Site
      • Setagaya-ku, Tokyo, Japan, 157-0073
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 140-0001
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 140-0014
        • Research Site
      • Suginami-ku, Tokyo, Japan, 166-0001
        • Research Site
      • Suginami-ku, Tokyo, Japan, 166-0003
        • Research Site
      • Toshima-ku, Tokyo, Japan, 171-0033
        • Research Site
    • Yamanashi
      • Kofu-shi, Yamanashi, Japan, 400-0831
        • Research Site
  • Latvia
      • Liepaja, Latvia, 3401
        • Research Site
      • Riga, Latvia, 1012
        • Research Site
      • Riga, Latvia, 1038
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 49287
        • Research Site
      • Kaunas, Lithuania, 49456
        • Research Site
      • Klaipeda, Lithuania, 94231
        • Research Site
      • Vilnius, Lithuania, 09310
        • Research Site
      • Vilnius, Lithuania, 10323
        • Research Site
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06100
        • Research Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Research Site
    • Sonora
      • Ciudad Obregon, Sonora, Mexico, 85000
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8022
        • Research Site
      • Grafton, Auckland, New Zealand, 1023
        • Research Site
  • Poland
      • Dabrowka Dopiewo, Poland, 62-069
        • Research Site
      • Elblag, Poland, 82-300
        • Research Site
      • Krakow, Poland, 30-510
        • Research Site
      • Lodz, Poland, 90-368
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Warszawa, Poland, 02-341
        • Research Site
      • Wroclaw, Poland, 51-124
        • Research Site
  • Romania
      • Bucharest, Romania, 011172
        • Research Site
      • Bucuresti, Romania, 020125
        • Research Site
      • Timisoara, Romania, 300736
        • Research Site
  • Spain
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28009
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08041
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Research Site
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Research Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Research Site
      • Fribourg, Switzerland, 1708
        • Research Site
      • Genève 14, Switzerland, 1211
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
      • Zurich, Switzerland, 8063
        • Research Site
      • Zurich, Switzerland, 8091
        • Research Site
  • United Kingdom
      • Chorley, United Kingdom, PR7 7NA
        • Research Site
      • Glasgow, United Kingdom, G20 0SP
        • Research Site
      • Liverpool, United Kingdom, L22 0LG
        • Research Site
      • London, United Kingdom, DA14 6LT
        • Research Site
      • Manchester, United Kingdom, M15 6SX
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Reading, United Kingdom, RG2 0TF
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Research Site
    • California
      • Laguna Hills, California, United States, 92653
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Sacramento, California, United States, 95817
        • Research Site
      • Santa Maria, California, United States, 93454
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Research Site
    • Florida
      • Leesburg, Florida, United States, 34748
        • Research Site
      • Palm Harbor, Florida, United States, 34684
        • Research Site
      • Plantation, Florida, United States, 33324
        • Research Site
      • Tampa, Florida, United States, 33614
        • Research Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Research Site
      • Mayfield, Ohio, United States, 44143
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • Texas
      • Denton, Texas, United States, 76210-8625
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Romosozumab
Administered by subcutaneous injection once a month (QM)
Other Names:
  • AMG 785
  • EVENITY™
Drug: Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)
Other Names:
  • Prolia®
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.
Drug: Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)
Other Names:
  • Prolia®
Drug: Placebo
Administered by subcutaneous injection once a month (QM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months
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.
12 Months
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.
24 Months
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.
24 Months
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.
12 Months
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.
24 Months
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.
12 Months
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.
24 Months
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.
12 Months
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.
24 Months
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 Months
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.
24 Months
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.
12 Months
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.
24 Months
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.
Baseline and Month 12
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.
Baseline and Month 24
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.
Baseline and Month 12
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.
Baseline and Month 24
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.
Baseline and Month 12
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.
Baseline and Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2012

Primary Completion (Actual)

December 14, 2015

Study Completion (Actual)

December 28, 2016

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimated)

April 12, 2012

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20070337
  • 2011-001456-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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