Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH)

November 4, 2022 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.

The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

Study Type

Interventional

Enrollment (Actual)

4093

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, C1012AAR
        • Research Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1430CKE
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1114
        • Research Site
      • Mar del Plata, Buenos Aires, Argentina, B7600DHK
        • Research Site
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Research Site
    • Córdoba
      • Cordoba, Córdoba, Argentina, X5000BNB
        • Research Site
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Research Site
      • Kogarah, New South Wales, Australia, 2217
        • Research Site
      • Randwick, New South Wales, Australia, 2031
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Research Site
      • Geelong, Victoria, Australia, 3220
        • Research Site
      • Heidelberg West, Victoria, Australia, 3081
        • Research Site
      • Parkville, Victoria, Australia, 3050
        • Research Site
  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Linz, Austria, 4010
        • Research Site
      • Wien, Austria, 1060
        • Research Site
  • Belgium
      • Brugge, Belgium, 8000
        • Research Site
      • Bruxelles, Belgium, 1000
        • Research Site
      • Genk, Belgium, 3600
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4020
        • Research Site
  • Brazil
      • Rio de Janeiro, Brazil, 22271-100
        • Research Site
      • São Paulo, Brazil, 04266-010
        • Research Site
      • São Paulo, Brazil, 05437-010
        • Research Site
    • Ceará
      • Fortaleza, Ceará, Brazil, 60115-282
        • Research Site
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 71625-009
        • Research Site
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Research Site
    • Goiás
      • Goiania, Goiás, Brazil, 74070-040
        • Research Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Research Site
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52020-010
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1202
        • Research Site
      • Sofia, Bulgaria, 1612
        • Research Site
      • Sofia, Bulgaria, 1504
        • Research Site
      • Sofia, Bulgaria, 1421
        • Research Site
      • Sofia, Bulgaria, 1709
        • Research Site
  • Canada
      • Quebec, Canada, G1V 3M7
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Research Site
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Research Site
    • Ontario
      • Kitchener, Ontario, Canada, N2M 1A1
        • Research Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Research Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Research Site
      • Westmout, Quebec, Canada, H3Z 1E5
        • Research Site
  • Chile
      • Santiago, Chile, 8350595
        • Research Site
  • Colombia
      • Bogota, Colombia, 11001000
        • Research Site
      • Bucaramanga, Colombia, 68003
        • 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
  • Czechia
      • Brno, Czechia, 602 00
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Klatovy, Czechia, 339 38
        • Research Site
      • Opava, Czechia, 746 01
        • Research Site
      • Ostrava-Trebovice, Czechia, 722 00
        • Research Site
      • Pardubice, Czechia, 530 02
        • Research Site
      • Plzen, Czechia, 305 99
        • Research Site
      • Praha 2, Czechia, 128 08
        • 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
      • Koge, Denmark, 4600
        • Research Site
      • Odense, Denmark, 5000
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
      • Århus C, Denmark, 8000
        • Research Site
  • Dominican Republic
      • Santiago, Dominican Republic, 51000
        • Research Site
      • 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
      • Tallinn, Estonia, 10128
        • Research Site
      • Tartu, Estonia, 50410
        • Research Site
  • Finland
      • Helsinki, Finland, 00100
        • Research Site
      • Jyväskylä, Finland, 40100
        • Research Site
      • Kuopio, Finland, 70211
        • Research Site
      • Turku, Finland, 20100
        • Research Site
  • France
      • Bordeaux Cedex, France, 33076
        • Research Site
      • Cahors Cedex, France, 46005
        • Research Site
      • Lille cedex, France, 59037
        • Research Site
      • Lyon Cédex 3, France, 69437
        • Research Site
      • Orleans Cedex, France, 45067
        • Research Site
      • Saint Priest en Jarez, France, 42270
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
      • Vandoeuvre les Nancy, France, 54511
        • Research Site
  • Germany
      • Berlin, Germany, 12200
        • Research Site
      • Berlin (Hellersdorf), Germany, 12627
        • Research Site
      • Bonn, Germany, 53105
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Frankfurt am Main, Germany, 60596
        • Research Site
      • Frankfurt am Main, Germany, 60528
        • Research Site
      • Freiburg, Germany, 79106
        • Research Site
      • Hamburg, Germany, 20354
        • Research Site
      • Hannover, Germany, 30167
        • Research Site
      • Heinsberg, Germany, 52525
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Magdeburg, Germany, 39104
        • Research Site
      • Marburg, Germany, 35043
        • Research Site
      • München, Germany, 80336
        • Research Site
      • Würzburg, Germany, 97074
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 16673
        • Research Site
      • Athens, Greece, 11526
        • Research Site
      • Athens, Greece, 14561
        • Research Site
      • Athens, Greece, 11525
        • Research Site
      • Larissa, Greece, 41110
        • Research Site
      • Thessaloniki, Greece, 54636
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
      • Thessaloniki, Greece, 56403
        • Research Site
  • Guatemala
      • Guatemala, Guatemala, 01001
        • Research Site
      • Guatemala, Guatemala, 01007
        • Research Site
      • Guatemala, Guatemala, 01009
        • Research Site
      • Guatemala, Guatemala, 01010
        • Research Site
      • Guatemala, Guatemala, 01012
        • Research Site
      • Guatemala, Guatemala, 01014
        • Research Site
      • Guatemala, Guatemala, 01015
        • Research Site
      • Guatemala, Guatemala, 01052
        • Research Site
    • Sacatepéquez
      • Antigua, Sacatepéquez, Guatemala, 03001
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • New Territories, Hong Kong
        • Research Site
  • Hungary
      • Balatonfured, Hungary, 8230
        • Research Site
      • Bekescsaba, Hungary, 5600
        • Research Site
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1084
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Gyor, Hungary, 9023
        • Research Site
      • Kaposvar, Hungary, 7400
        • Research Site
      • Kiskunhalas, Hungary, 6400
        • Research Site
      • Kistarcsa, Hungary, 2143
        • Research Site
      • Veszprem, Hungary, 8200
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Ireland
      • Cork, Ireland
        • Research Site
      • Dublin, Ireland, 8
        • Research Site
      • Galway, Ireland
        • Research Site
  • Israel
      • Bnei Brak, Israel, 51108
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Jerusalem, Israel, 71713
        • Research Site
      • Jerusalem, Israel, 91007
        • Research Site
      • Tel Aviv, Israel, 61999
        • Research Site
  • Italy
      • Arenzano GE, Italy, 16011
        • Research Site
      • Bologna, Italy, 40138
        • Research Site
      • Catania, Italy, 95124
        • Research Site
      • Firenze, Italy, 50139
        • Research Site
      • Milan, Italy, 20145
        • Research Site
      • Pisa, Italy, 56126
        • Research Site
      • Pisa, Italy, 56124
        • Research Site
      • Roma, Italy, 00161
        • Research Site
      • Siena, Italy, 53100
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Verona, Italy, 37126
        • Research Site
      • Verona, Italy, 37134
        • Research Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Research Site
      • Guri-si, Korea, Republic of, 471-701
        • Research Site
      • Gwangju, Korea, Republic of, 501-757
        • Research Site
      • Incheon, Korea, Republic of, 405-760
        • Research Site
      • Seoul, Korea, Republic of, 120-752
        • Research Site
      • Seoul, Korea, Republic of, 110-744
        • Research Site
      • Seoul, Korea, Republic of, 136-705
        • Research Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
        • Research Site
  • Latvia
      • Liepaja, Latvia, 3401
        • Research Site
      • Riga, Latvia, 1012
        • Research Site
      • Riga, Latvia, 1011
        • Research Site
  • Lithuania
      • Vilnius, Lithuania, 09310
        • Research Site
      • Vilnius, Lithuania, 10323
        • Research Site
  • Mexico
    • Baja California Norte
      • Mexicali, Baja California Norte, Mexico, 21100
        • Research Site
      • Mexicalli, Baja California Norte, Mexico, 21200
        • Research Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06100
        • Research Site
      • Mexico, Distrito Federal, Mexico, 06700
        • Research Site
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37520
        • Research Site
      • Leon, Guanajuato, Mexico, 37000
        • Research Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Research Site
    • Querétaro
      • Queretaro, Querétaro, Mexico, 76000
        • Research Site
    • Sonora
      • Ciudad Obregon, Sonora, Mexico, 85000
        • Research Site
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Research Site
      • Rotterdam, Netherlands, 3015 CE
        • Research Site
      • Venlo, Netherlands, 5912 BL
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8022
        • Research Site
      • Grafton, Auckland, New Zealand, 1023
        • Research Site
  • Norway
      • Elverum, Norway, 2408
        • Research Site
      • Hamar, Norway, 2317
        • Research Site
      • Oslo, Norway, 0050
        • Research Site
      • Stavanger, Norway, 4005
        • Research Site
  • Peru
      • Lima, Peru, LIMA 27
        • Research Site
      • Lima, Peru, LIMA 33
        • Research Site
      • Lima, Peru, Lima11
        • Research Site
  • Poland
      • Bialystok, Poland, 15-879
        • Research Site
      • Bialystok, Poland, 15-351
        • Research Site
      • Dabrowka Dopiewo, Poland, 62-069
        • Research Site
      • Elblag, Poland, 82-300
        • Research Site
      • Gdynia, Poland, 81-384
        • Research Site
      • Gliwice, Poland, 44-100
        • Research Site
      • Katowice, Poland, 40-040
        • Research Site
      • Kielce, Poland, 25-317
        • Research Site
      • Krakow, Poland, 30-510
        • Research Site
      • Kraków, Poland, 31-501
        • Research Site
      • Lodz, Poland, 90-558
        • Research Site
      • Lodz, Poland, 09-245
        • Research Site
      • Poznan, Poland, 60-356
        • Research Site
      • Poznan, Poland, 60-702
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Torun, Poland, 87-100
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Warszawa, Poland, 02-507
        • Research Site
      • Warszawa, Poland, 04-730
        • Research Site
      • Wroclaw, Poland, 50-088
        • Research Site
      • Wroclaw, Poland, 51-124
        • Research Site
      • Wroclaw, Poland, 53-224
        • Research Site
  • Romania
      • Bucharest, Romania, 011172
        • Research Site
      • Bucharest, Romania, 011863
        • Research Site
      • Bucharest, Romania, 030463
        • Research Site
      • Bucuresti, Romania, 020125
        • Research Site
      • Bucuresti, Romania, 011863
        • Research Site
      • Oradea, Romania, 410028
        • Research Site
      • Targu Mures, Romania, 540142
        • Research Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163001
        • Research Site
      • Ekaterinburg, Russian Federation, 620102
        • Research Site
      • Ivanovo, Russian Federation, 153025
        • Research Site
      • Moscow, Russian Federation, 101990
        • Research Site
      • Moscow, Russian Federation, 115522
        • Research Site
      • Moscow, Russian Federation, 117036
        • Research Site
      • Moscow, Russian Federation, 127299
        • Research Site
      • Nizhniy Novgorod, Russian Federation, 603155
        • Research Site
      • Petrozavodsk, Russian Federation, 185019
        • Research Site
      • Saint Petersburg, Russian Federation, 194291
        • Research Site
      • Saint Petersburg, Russian Federation, 190103
        • Research Site
      • Saint-Petersburg, Russian Federation, 199034
        • Research Site
      • Yaroslavl, Russian Federation, 150003
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Bratislava, Slovakia, 826 06
        • Research Site
      • Bratislava, Slovakia, 813 69
        • Research Site
      • Kosice-Saca, Slovakia, 040 15
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Piestany, Slovakia, 921 12
        • Research Site
      • Trencin, Slovakia, 911 01
        • Research Site
  • South Africa
      • Tygerberg, South Africa, 7505
        • Research Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Research Site
      • Pretoria, Gauteng, South Africa, 0184
        • Research Site
      • Pretoria, Gauteng, South Africa, 0181
        • Research Site
    • Western Cape
      • Parow, Western Cape, South Africa, 7500
        • Research Site
      • Somerset West, Western Cape, South Africa, 7130
        • Research Site
  • Spain
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28006
        • Research Site
    • Andalucía
      • Granada, Andalucía, Spain, 18012
        • Research Site
      • Sevilla, Andalucía, Spain, 41009
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Research Site
      • Sant Joan Despi, Cataluña, Spain, 08970
        • Research Site
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Research Site
  • Sweden
      • Linköping, Sweden, 581 85
        • Research Site
      • Mölndal, Sweden, 431 80
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Umeå, Sweden, 907 36
        • Research Site
  • Taiwan
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
  • Turkey
      • Adana, Turkey, 01330
        • Research Site
      • Istanbul, Turkey, 34093
        • Research Site
      • Istanbul, Turkey, 34890
        • Research Site
      • Izmir, Turkey, 35100
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Research Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Research Site
      • Cardiff, United Kingdom, CF14 5GJ
        • Research Site
      • Chorley, United Kingdom, PR7 7NA
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • Glasgow, United Kingdom, G20 0SP
        • Research Site
      • Liverpool, United Kingdom, L22 0LG
        • Research Site
      • Manchester, United Kingdom, M15 6SX
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Norwich, United Kingdom, NR4 7TJ
        • Research Site
      • Reading, United Kingdom, RG2 0FT
        • Research Site
      • Sheffield, United Kingdom, S5 7AU
        • Research Site
      • Sidcup, United Kingdom, DA14 6LT
        • Research Site
      • Staffordshire, United Kingdom, WS11 5XY
        • Research Site
      • Warwick, United Kingdom, CV34 5BW
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Research Site
      • Phoenix, Arizona, United States, 85037
        • Research Site
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • California
      • Downey, California, United States, 90242
        • Research Site
      • Greenbrae, California, United States, 94904
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • South Lake Tahoe, California, United States, 96150
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Research Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33309
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
      • Stuart, Florida, United States, 34996
        • Research Site
      • West Palm Beach, Florida, United States, 33409
        • Research Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Research Site
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Research Site
      • Quincy, Illinois, United States, 62301
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • 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
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Research Site
    • New Mexico
      • Las Cruces, New Mexico, United States, 88011
        • Research Site
    • New York
      • Great Neck, New York, United States, 11021
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58503
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23233
        • Research Site
    • Washington
      • Port Angeles, Washington, United States, 98362
        • 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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alendronate/Alendronate
Participants 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.
Drug: Alendronate
Alendronate 70 mg tablet taken once a week
Other Names:
  • Fosamax
Drug: Placebo to Romosozumab
Administered by subcutaneous injection once a month during the double-blind treatment phase.
EXPERIMENTAL: Romosozumab/Alendronate
Participants 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.
Drug: Alendronate
Alendronate 70 mg tablet taken once a week
Other Names:
  • Fosamax
Biological: Romosozumab
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
Other Names:
  • AMG 785
  • Evenity
Drug: Placebo to Alendronate
Matching placebo tablet taken once a week during the double-blind treatment phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With New Vertebral Fractures Through Month 24
Time Frame: 24 months

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
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
Time Frame: 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).
A nonvertebral fracture was defined as a documented fracture 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.
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
Time Frame: 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).
All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.
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
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 according to 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 Major Nonvertebral Fracture at the Primary Analysis
Time Frame: 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).
Major nonvertebral fractures included 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.
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
Time Frame: 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).
Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
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 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 according to the Genant Semiquantitative Scoring method. 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. Incident vertebral fractures were confirmed by a second independent reader.
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 Nonvertebral Fracture Through Month 24
Time Frame: 24 months
A nonvertebral fracture was defined as a documented fracture 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 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 Clinical Vertebral Fracture Through Month 24
Time Frame: 24 months
A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.
24 months
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 New Vertebral Fractures 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 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.
12 months
Percentage of Participants With Any Fracture Through Month 12
Time Frame: 12 months
All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.
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 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 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 Clinical Vertebral Fracture Through Month 12
Time Frame: 12 months
A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.
12 months
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 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 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 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 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 at 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 Lumbar Spine at Month 36
Time Frame: Baseline and month 36
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 36
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36
Time Frame: Baseline and month 36
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 36
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36
Time Frame: Baseline and month 36
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 36

Collaborators and Investigators

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Sponsor

Amgen

Publications and helpful links

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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)

May 4, 2012

Primary Completion (ACTUAL)

February 27, 2017

Study Completion (ACTUAL)

June 29, 2017

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (ESTIMATE)

June 29, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110142
  • 2011-003142-41 (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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