Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
ARCH
A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
2 other identifiers
interventional
4,093
40 countries
301
Brief Summary
The purpose of this study is to determine if treatment 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 May 2012
Longer than P75 for phase_3
301 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
May 4, 2012
CompletedFirst Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2017
CompletedResults Posted
Study results publicly available
December 12, 2018
CompletedFebruary 21, 2025
February 1, 2025
4.8 years
May 24, 2012
November 20, 2018
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With New Vertebral Fractures Through Month 24
All fracture assessments were performed by blinded central imaging readers. 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 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. Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.
24 months
Percentage of Participants With a Clinical Fracture at the Primary Analysis
All fracture assessments were performed by blinded central imaging readers. 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.
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Secondary Outcomes (26)
Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With Any Fracture at the Primary Analysis
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
24 months
Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With a Hip Fracture at the Primary Analysis
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
- +21 more secondary outcomes
Study Arms (2)
Alendronate/Alendronate
ACTIVE COMPARATORParticipants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
Romosozumab/Alendronate
EXPERIMENTALParticipants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
Interventions
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
Alendronate 70 mg tablet taken once a week
Administered by subcutaneous injection once a month during the double-blind treatment phase.
Matching placebo tablet taken once a week during the double-blind treatment phase.
Eligibility Criteria
You may qualify if:
- Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:
- BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
- at least 1 moderate (semiquantitative grade \[SQ\]2) or severe (SQ3) vertebral fracture OR
- at least 2 mild (SQ1) vertebral fractures OR
- BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
- at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
- a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.
You may not qualify if:
- History of metabolic or bone disease (except osteoporosis)
- Use of agents affecting bone metabolism
- Vitamin D insufficiency
- History of solid organ or bone marrow transplants
- Hyper- or hypocalcemia
- Hyper- or hypothyroidism
- Hyper- or hypoparathyroidism
- Possible signs of intolerance to alendronate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (316)
Research Site
Birmingham, Alabama, 35294, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85037, United States
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Scottsdale, Arizona, 85258, United States
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Downey, California, 90242, United States
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Greenbrae, California, 94904, United States
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Los Angeles, California, 90057, United States
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South Lake Tahoe, California, 96150, United States
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Tustin, California, 92780, 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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Fort Lauderdale, Florida, 33309, United States
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Miami, Florida, 33136, United States
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Stuart, Florida, 34996, United States
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West Palm Beach, Florida, 33409, United States
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Gainesville, Georgia, 30501, United States
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Maywood, Illinois, 60153, United States
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Quincy, Illinois, 62301, United States
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Indianapolis, Indiana, 46202, 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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St Louis, Missouri, 63110, United States
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Las Vegas, Nevada, 89148, United States
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Las Cruces, New Mexico, 88011, United States
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Great Neck, New York, 11021, United States
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Bismarck, North Dakota, 58503, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Wyomissing, Pennsylvania, 19610, United States
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Richmond, Virginia, 23233, United States
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Port Angeles, Washington, 98362, United States
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Madison, Wisconsin, 53705, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1114, 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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Quilmes, Buenos Aires, B1878DVB, Argentina
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Córdoba, Córdoba Province, X5000BNB, Argentina
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Buenos Aires, C1012AAR, Argentina
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Darlinghurst, New South Wales, 2010, Australia
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Kogarah, New South Wales, 2217, Australia
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Randwick, New South Wales, 2031, Australia
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Box Hill, Victoria, 3128, Australia
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Geelong, Victoria, 3220, Australia
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Heidelberg West, Victoria, 3081, Australia
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Parkville, Victoria, 3050, Australia
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Graz, 8036, Austria
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Linz, 4010, Austria
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Vienna, 1060, Austria
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Bruges, 8000, Belgium
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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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Fortaleza, Ceará, 60115-282, Brazil
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Vitória, Espírito Santo, 29055-450, Brazil
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Brasília, Federal District, 71625-009, Brazil
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Goiânia, Goiás, 74070-040, Brazil
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Curitiba, Paraná, 80030-110, Brazil
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Recife, Pernambuco, 52020-010, Brazil
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Rio de Janeiro, 22271-100, Brazil
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São Paulo, 04266-010, Brazil
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São Paulo, 05437-010, Brazil
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Plovdiv, 4002, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1421, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1504, Bulgaria
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Sofia, 1612, Bulgaria
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Sofia, 1709, Bulgaria
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Vancouver, British Columbia, V5Z 4E1, Canada
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Winnipeg, Manitoba, R3A 1M3, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Kitchener, Ontario, N2M 1A1, Canada
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Toronto, Ontario, M5C 2T2, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1V 3M7, Canada
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Trois-Rivières, Quebec, G8Z 1Y2, Canada
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Westmout, Quebec, H3Z 1E5, Canada
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Santiago, 8350595, Chile
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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, Colombia
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Bogotá, 11001000, Colombia
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Bucaramanga, 68003, Colombia
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Brno, 602 00, Czechia
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Hradec Králové, 500 05, Czechia
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Klatovy, 339 38, Czechia
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Opava, 746 01, 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 08, Czechia
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Prague, 130 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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Køge, 4600, 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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Santiago de los Caballeros, Santiago Province, 51000, Dominican Republic
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Santo Domingo, 10605, Dominican Republic
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Tallinn, 10128, Estonia
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Tartu, 50410, Estonia
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Helsinki, 00100, Finland
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Jyväskylä, 40100, Finland
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Kuopio, 70211, Finland
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Turku, 20100, Finland
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Bordeaux, 33076, France
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Cahors, 46005, France
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Lille, 59037, France
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Lyon Cédex 3, 69437, France
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Orléans, 45067, France
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Saint-Priest-en-Jarez, 42270, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Berlin, 12200, Germany
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Bonn, 53105, Germany
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Dresden, 01307, Germany
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Frankfurt am Main, 60528, Germany
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Frankfurt am Main, 60596, Germany
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Freiburg im Breisgau, 79106, 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, 39104, Germany
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Marburg, 35043, Germany
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München, 80336, Germany
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Würzburg, 97074, Germany
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Athens, 11525, Greece
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Athens, 11526, Greece
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Athens, 11527, Greece
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Athens, 14561, Greece
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Athens, 16673, Greece
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Larissa, 41110, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 56403, Greece
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Thessaloniki, 56429, Greece
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Antigua Guatemala, Departamento de Sacatepéquez, 03001, Guatemala
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Guatemala City, 01001, Guatemala
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Guatemala City, 01007, Guatemala
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Guatemala City, 01009, Guatemala
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Guatemala City, 01010, Guatemala
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Guatemala City, 01012, Guatemala
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Guatemala City, 01014, Guatemala
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Guatemala City, 01015, Guatemala
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Guatemala City, 01052, Guatemala
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Balatonfüred, 8230, Hungary
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Békéscsaba, 5600, Hungary
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Budapest, 1036, Hungary
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Budapest, 1083, Hungary
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Budapest, 1084, Hungary
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Debrecen, 4032, Hungary
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Győr, 9023, Hungary
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Kaposvár, 7400, Hungary
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Kiskunhalas, 6400, Hungary
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Kistarcsa, 2143, Hungary
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Veszprém, 8200, Hungary
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Zalaegerszeg, 8900, Hungary
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Cork, Ireland
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Dublin, 8, Ireland
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Galway, Ireland
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Bnei Brak, 51108, Israel
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Haifa, 31096, Israel
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Jerusalem, 71713, Israel
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Jerusalem, 91007, Israel
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Tel Aviv, 61999, Israel
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Arenzano GE, 16011, Italy
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Bologna, 40138, Italy
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Catania, 95124, Italy
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Florence, 50139, Italy
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Milan, 20145, Italy
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Pisa, 56124, Italy
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Pisa, 56126, Italy
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Roma, 00161, Italy
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Siena, 53100, Italy
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Torino, 10126, Italy
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Verona, 37126, Italy
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Verona, 37134, Italy
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Liepāja, 3401, Latvia
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Riga, 1011, Latvia
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Riga, 1012, Latvia
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Vilnius, 09310, Lithuania
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Vilnius, 10323, Lithuania
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Mexicali, Baja California Norte, 21100, Mexico
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Mexicalli, Baja California Norte, 21200, Mexico
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León, Guanajuato, 37000, Mexico
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León, Guanajuato, 37520, Mexico
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Mexico City, Mexico City, 06100, Mexico
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Mexico City, Mexico City, 06700, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Querétaro City, Querétaro, 76000, Mexico
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Ciudad Obregón, Sonora, 85000, Mexico
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Leiden, 2333 ZA, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Venlo, 5912 BL, Netherlands
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Christchurch, 8022, New Zealand
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Grafton, Auckland, 1023, New Zealand
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Elverum, 2408, Norway
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Hamar, 2317, Norway
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Oslo, 0050, Norway
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Stavanger, 4005, Norway
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Lima, Lima 27, Peru
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Lima, Lima 33, Peru
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Lima, Lima11, Peru
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Bialystok, 15-351, Poland
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Bialystok, 15-879, Poland
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Dabrowka Dopiewo, 62-069, Poland
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Elblag, 82-300, Poland
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Gdynia, 81-384, Poland
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Gliwice, 44-100, Poland
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Katowice, 40-040, Poland
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Kielce, 25-317, Poland
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Krakow, 30-510, Poland
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Krakow, 31-501, Poland
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Lodz, 09-245, Poland
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Lodz, 90-558, Poland
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Poznan, 60-356, Poland
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Poznan, 60-702, Poland
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Świdnik, 21-040, Poland
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Torun, 87-100, Poland
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Warsaw, 01-192, Poland
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Warsaw, 02-507, Poland
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Warsaw, 04-730, Poland
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Wroclaw, 50-088, Poland
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Wroclaw, 51-124, Poland
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Wroclaw, 53-224, Poland
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Bucharest, 011172, Romania
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Bucharest, 011863, Romania
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Bucharest, 020125, Romania
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Bucharest, 030463, Romania
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Oradea, 410028, Romania
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Târgu Mureş, 540142, Romania
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Arkhangelsk, 163001, Russia
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Ivanovo, 153025, Russia
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Moscow, 101990, Russia
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Moscow, 115522, Russia
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Moscow, 117036, Russia
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Moscow, 127299, Russia
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Nizhny Novgorod, 603155, Russia
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Petrozavodsk, 185019, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 199034, Russia
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Yaroslavl, 150003, Russia
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Yekaterinburg, 620102, Russia
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Banská Bystrica, 974 01, Slovakia
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Bratislava, 813 69, Slovakia
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Bratislava, 826 06, Slovakia
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Kosice-Saca, 040 15, Slovakia
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Lučenec, 984 01, Slovakia
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Piešťany, 921 12, Slovakia
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Trenčín, 911 01, Slovakia
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Johannesburg, Gauteng, 2196, South Africa
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Pretoria, Gauteng, 0181, South Africa
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Pretoria, Gauteng, 0184, South Africa
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Parow, Western Cape, 7500, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Tygerberg, 7505, South Africa
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Daegu, 700-712, South Korea
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Guri-si, 471-701, South Korea
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Gwangju, 501-757, South Korea
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Incheon, 405-760, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 136-705, South Korea
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Suwon-si, Gyeonggi-do, 443-380, South Korea
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Granada, Andalusia, 18012, Spain
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Seville, Andalusia, 41009, Spain
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Santander, Cantabria, 39008, Spain
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Barcelona, Catalonia, 08003, Spain
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Sant Joan Despí, Catalonia, 08970, Spain
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A Coruña, Galicia, 15006, Spain
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Madrid, 28006, Spain
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Madrid, 28046, Spain
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Linköping, 581 85, Sweden
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Mölndal, 431 80, Sweden
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Stockholm, 141 86, Sweden
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Umeå, 907 36, Sweden
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Adana, 01330, Turkey (Türkiye)
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Istanbul, 34093, Turkey (Türkiye)
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Istanbul, 34890, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Birmingham, B15 2SQ, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Cardiff, CF14 5GJ, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Glasgow, G20 0SP, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Norwich, NR4 7TJ, United Kingdom
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Reading, RG2 0FT, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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Sidcup, DA14 6LT, United Kingdom
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Staffordshire, WS11 5XY, United Kingdom
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Warwick, CV34 5BW, United Kingdom
Related Publications (8)
Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
PMID: 28892457BACKGROUNDCosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.
PMID: 32445228BACKGROUNDLau EMC, Dinavahi R, Woo YC, Wu CH, Guan J, Maddox J, Tolman C, Yang W, Shin CS. Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study. Osteoporos Int. 2020 Apr;31(4):677-685. doi: 10.1007/s00198-020-05324-0. Epub 2020 Feb 11.
PMID: 32047951BACKGROUNDMiller 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: 35466448BACKGROUNDBrown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.
PMID: 34190361BACKGROUNDMcClung MR, Betah D, Leder BZ, Kendler DL, Oates M, Timoshanko J, Wang Z. Romosozumab improves microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis. J Bone Miner Res. 2025 Feb 2;40(2):193-200. doi: 10.1093/jbmr/zjae194.
PMID: 39656908BACKGROUNDFerrari S, Betah D, Feldman RG, Langdahl BL, Oates M, Timoshanko J, Wang Z, Dhaliwal R. Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes. J Clin Endocrinol Metab. 2025 Sep 16;110(10):2861-2868. doi: 10.1210/clinem/dgae862.
PMID: 39854280BACKGROUNDLane 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
May 24, 2012
First Posted
June 29, 2012
Study Start
May 4, 2012
Primary Completion
February 27, 2017
Study Completion
June 29, 2017
Last Updated
February 21, 2025
Results First Posted
December 12, 2018
Record last verified: 2025-02