Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
FRAME
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
2 other identifiers
interventional
7,180
23 countries
215
Brief Summary
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2012
Longer than P75 for phase_3
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2012
CompletedFirst Submitted
Initial submission to the registry
April 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2016
CompletedResults Posted
Study results publicly available
November 8, 2018
CompletedAugust 28, 2024
August 1, 2024
3.8 years
April 4, 2012
September 24, 2018
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
24 months
Secondary Outcomes (20)
Percentage of Participants With a Clinical Fracture Through Month 12
12 Months
Percentage of Participants With a Nonvertebral Fracture Through Month 12
12 Months
Percentage of Participants With a Nonvertebral Fracture Through Month 24
24 Months
Percentage of Participants With a Clinical Fracture Through Month 24
24 Months
Percentage of Participants With a Major Nonvertebral Fracture Through Month 12
12 Months
- +15 more secondary outcomes
Study Arms (2)
Romosozumab
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Interventions
Administered by subcutaneous injection once a month (QM)
Administered by subcutaneous injection once every 6 months (Q6M)
Eligibility Criteria
You may qualify if:
- \- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (218)
Research Site
Tucson, Arizona, 85704, United States
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Laguna Hills, California, 92653, United States
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Los Angeles, California, 90057, United States
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Sacramento, California, 95817, United States
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Santa Maria, California, 93454, United States
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Walnut Creek, California, 94598, United States
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Lakewood, Colorado, 80227, United States
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Leesburg, Florida, 34748, United States
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Palm Harbor, Florida, 34684, United States
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Plantation, Florida, 33324, United States
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Tampa, Florida, 33614, United States
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Gainesville, Georgia, 30501, United States
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New Orleans, Louisiana, 70121, United States
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Bethesda, Maryland, 20817, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48236, United States
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Albuquerque, New Mexico, 87106, United States
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Asheville, North Carolina, 28803, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45236, United States
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Mayfield, Ohio, 44143, United States
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Duncansville, Pennsylvania, 16635, United States
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Denton, Texas, 76210-8625, United States
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Richmond, Virginia, 23294, United States
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Madison, Wisconsin, 53705, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1015ABO, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430CKE, Argentina
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Mar del Plata, Buenos Aires, B7600DHK, Argentina
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Córdoba, Córdoba Province, X5000BNB, Argentina
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Buenos Aires, 1425, Argentina
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Buenos Aires, C1425ACG, Argentina
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Maroubra, New South Wales, 2035, Australia
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St Leonards, New South Wales, 2065, Australia
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Herston, Queensland, 4029, Australia
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Keswick, South Australia, 5035, Australia
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Footscray, Victoria, 3011, Australia
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Geelong, Victoria, 3220, Australia
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Heidelberg West, Victoria, 3081, Australia
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Nedlands, Western Australia, 6009, Australia
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Brussels, 1000, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4020, Belgium
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Lommel, 3920, Belgium
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Yvoir, 5530, Belgium
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Curitiba, Paraná, 80030-110, Brazil
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São Paulo, São Paulo, 04063-001, Brazil
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São Paulo, 04266-010, Brazil
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São Paulo, 05403-000, Brazil
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São Paulo, 05437-010, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Vancouver, British Columbia, V5Z 4E1, Canada
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Hamilton, Ontario, L8N 1Y2, Canada
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Oakville, Ontario, L6M 1M1, Canada
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Lachine, Quebec, H8S 2E4, Canada
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Québec, Quebec, G1V 3M7, Canada
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Medellín, Antioquia, 050021, Colombia
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Barranquilla, Atlántico, 08001000, Colombia
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Bogota, Cundinamarca, 11001000, Colombia
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Bogota, Cundinamarca, 110221, Colombia
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Bogota, Cundinamarca, 1, Colombia
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Bogota, Cundinamarca, Colombia
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Bogotá, 11001000, Colombia
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Brno, 602 00, Czechia
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České Budějovice, 370 87, Czechia
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Havlíčkův Brod, 580 22, Czechia
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Klatovy, 339 38, Czechia
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Ostrava-Trebovice, 722 00, Czechia
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Pardubice, 530 02, Czechia
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Pilsen, 305 99, Czechia
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Prague, 128 50, Czechia
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Prague, 130 00, Czechia
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Praha 11 - Chodov, 148 00, Czechia
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Uherské Hradiště, 686 01, Czechia
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Zlín, 760 01, Czechia
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Aalborg, 9000, Denmark
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Århus C, 8000, Denmark
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Ballerup Municipality, 2750, Denmark
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Glostrup Municipality, 2600, Denmark
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Hvidovre, 2650, Denmark
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Odense, 5000, Denmark
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Vejle, 7100, Denmark
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Santo Domingo, Nacional, 10124, Dominican Republic
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Santo Domingo, Nacional, 10514, Dominican Republic
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Santo Domingo, 10605, Dominican Republic
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Pärnu, 80013, Estonia
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Tallinn, 10128, Estonia
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Tartu, 50410, Estonia
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Berlin, 12200, Germany
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Bochum, 44787, Germany
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Dresden, 01067, Germany
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Dresden, 01307, Germany
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Frankfurt am Main, 60313, Germany
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Frankfurt am Main, 60528, Germany
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Görlitz, 02826, Germany
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Hamburg, 20354, Germany
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Hanover, 30167, Germany
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Heinsberg, 52525, Germany
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Hellersdorf, 12627, Germany
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Leipzig, 04103, Germany
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Magdeburg, 39120, Germany
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Marburg, 35043, Germany
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Schkeuditz, 04435, Germany
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Békéscsaba, 5600, Hungary
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Budapest, 1027, Hungary
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Budapest, 1036, Hungary
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Budapest, 1083, Hungary
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Debrecen, 4032, Hungary
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Győr, 9023, Hungary
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Hévíz, 8380, Hungary
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Szeged, 6720, Hungary
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Zalaegerszeg, 8900, Hungary
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Bangalore, Karnataka, 560 054, India
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Mumbai, Maharashtra, 400 012, India
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Pune, Maharashtra, 411 005, India
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Jaipur, Rajasthan, 302 019, India
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Chennai, Tamil Nadu, 600 020, India
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Vellore, Tamil Nadu, 632 004, India
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Anjyo-shi, Aichi-ken, 446-0063, Japan
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Urayasu-shi, Chiba, 279-0004, Japan
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Fukui-shi, Fukui, 910-0005, Japan
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Fukui-shi, Fukui, 910-0067, Japan
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Fukui-shi, Fukui, 918-8057, Japan
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Fukui-shi, Fukui, 918-8236, Japan
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Fukuoka, Fukuoka, 814-0111, Japan
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Fukutsu-shi, Fukuoka, 811-3217, Japan
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Kitakyushu-shi, Fukuoka, 806-0026, Japan
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Kurume-shi, Fukuoka, 830-0053, Japan
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Kurume-shi, Fukuoka, 839-0832, Japan
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Hiroshima, Hiroshima, 733-0032, Japan
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Chitose-shi, Hokkaido, 066-0062, Japan
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Ishikari-shi, Hokkaido, 061-3203, Japan
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Sunagawa-shi, Hokkaido, 073-0196, Japan
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Akashi-shi, Hyōgo, 674-0051, Japan
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Kako-gun, Hyōgo, 675-1115, Japan
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Toride-shi, Ibaraki, 302-0022, Japan
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Morioka, Iwate, 020-0015, Japan
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Takamatsu, Kagawa-ken, 760-8538, Japan
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Kirishima-shi, Kagoshima-ken, 899-5102, Japan
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Minamikyusyu-shi, Kagoshima-ken, 897-0215, Japan
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Atugi-shi, Kanagawa, 243-0122, Japan
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Sagamihara-shi, Kanagawa, 252-5225, Japan
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Yokohama, Kanagawa, 223-0059, Japan
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Yokohama, Kanagawa, 223-0062, Japan
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Yokohama, Kanagawa, 227-0064, Japan
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Yokohama, Kanagawa, 231-0023, Japan
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Yokohama, Kanagawa, 231-0861, Japan
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Kumamoto, Kumamoto, 860-0066, Japan
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Sendai, Miyagi, 981-3213, Japan
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Chiisagata-gun, Nagano, 386-0603, Japan
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Matsumoto-shi, Nagano, 390-1401, Japan
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Matsumoto-shi, Nagano, 390-8601, Japan
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Ueda-shi, Nagano, 386-0151, Japan
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Ueda-shi, Nagano, 386-0405, Japan
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Bungoono-shi, Oita Prefecture, 879-7125, Japan
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Osaka, Osaka, 559-0011, Japan
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Takatsuki-shi, Osaka, 569-1123, Japan
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Saga, Saga-ken, 840-0027, Japan
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Fujimi-shi, Saitama, 354-0021, Japan
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Matsue, Shimane, 699-0293, Japan
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Fujinomiya-shi, Shizuoka, 418-0026, Japan
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Kikugawa-shi, Shizuoka, 439-0012, Japan
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Tokushima, Tokushima, 770-8503, Japan
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Hachioji-shi, Tokyo, 192-0046, Japan
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Kiyose-shi, Tokyo, 204-0021, Japan
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Minato-ku, Tokyo, 108-0075, Japan
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Ōta-ku, Tokyo, 143-0015, Japan
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Setagaya-ku, Tokyo, 157-0073, Japan
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Shinagawa-ku, Tokyo, 140-0001, Japan
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Shinagawa-ku, Tokyo, 140-0014, Japan
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Suginami-ku, Tokyo, 166-0001, Japan
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Suginami-ku, Tokyo, 166-0003, Japan
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Toshima-ku, Tokyo, 171-0033, Japan
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Kofu, Yamanashi, 400-0831, Japan
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Liepāja, 3401, Latvia
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Riga, 1012, Latvia
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Riga, 1038, Latvia
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Kaunas, 49287, Lithuania
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Kaunas, 49456, Lithuania
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Klaipėda, 94231, Lithuania
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Vilnius, 09310, Lithuania
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Vilnius, 10323, Lithuania
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Mexico City, Mexico City, 06100, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Ciudad Obregón, Sonora, 85000, Mexico
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Christchurch, 8022, New Zealand
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Grafton, Auckland, 1023, New Zealand
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Dabrowka Dopiewo, 62-069, Poland
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Elblag, 82-300, Poland
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Krakow, 30-510, Poland
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Lodz, 90-368, Poland
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Świdnik, 21-040, Poland
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Warsaw, 02-341, Poland
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Wroclaw, 51-124, Poland
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Bucharest, 011172, Romania
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Bucharest, 020125, Romania
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Timișoara, 300736, Romania
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Barcelona, Catalonia, 08041, Spain
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Pozuelo de Alarcón, Madrid, 28223, Spain
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Valencia, Valencia, 46026, Spain
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Madrid, 28009, Spain
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Madrid, 28041, Spain
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Bern, 3010, Switzerland
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Fribourg, 1708, Switzerland
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Geneva, 1211, Switzerland
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Lausanne, 1011, Switzerland
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Zurich, 8063, Switzerland
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Zurich, 8091, Switzerland
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Chorley, PR7 7NA, United Kingdom
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Glasgow, G20 0SP, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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London, DA14 6LT, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Reading, RG2 0TF, United Kingdom
Related Publications (17)
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.
PMID: 27641143BACKGROUNDCosman 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.
PMID: 29573473BACKGROUNDChavassieux 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.
PMID: 31233639BACKGROUNDCosman 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.
PMID: 29750828BACKGROUNDLewiecki 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.
PMID: 30508316BACKGROUNDMiyauchi 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.
PMID: 31168657BACKGROUNDMiyauchi 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.
PMID: 33057807BACKGROUNDMcCloskey 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.
PMID: 33537844BACKGROUNDEriksen 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.
PMID: 34633116BACKGROUNDMiller 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.
PMID: 35466448BACKGROUNDTakada 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.
PMID: 31707465BACKGROUNDMiyauchi 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.
PMID: 35639174BACKGROUNDEriksen 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 Jul 23;39(6):729-736. doi: 10.1093/jbmr/zjae055.
PMID: 38640512BACKGROUNDLane 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.
PMID: 37985218BACKGROUNDMcClung 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.
PMID: 37406858BACKGROUNDCosman F, Oates M, Betah D, Timoshanko J, Wang Z, Ferrari S, McClung MR. Romosozumab followed by denosumab versus denosumab only: a post hoc analysis of FRAME and FRAME extension. J Bone Miner Res. 2024 Sep 2;39(9):1268-1277. doi: 10.1093/jbmr/zjae116.
PMID: 39041711BACKGROUNDLane J, Langdahl B, Stone M, Kurth A, Oates M, Timoshanko J, Wang Z, Libanati C, Cosman F. Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials. Osteoporos Int. 2024 Jul;35(7):1195-1204. doi: 10.1007/s00198-024-07049-w. Epub 2024 Apr 4.
PMID: 38573517DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2012
First Posted
April 12, 2012
Study Start
March 15, 2012
Primary Completion
December 14, 2015
Study Completion
December 28, 2016
Last Updated
August 28, 2024
Results First Posted
November 8, 2018
Record last verified: 2024-08