Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01631214




Registration number
NCT01631214
Ethics application status
Date submitted
24/05/2012
Date registered
29/06/2012
Date last updated
8/11/2022

Titles & IDs
Public title
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Scientific title
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
Secondary ID [1] 0 0
2011-003142-41
Secondary ID [2] 0 0
20110142
Universal Trial Number (UTN)
Trial acronym
ARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Women With Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Romosozumab
Treatment: Drugs - Alendronate
Treatment: Drugs - Placebo to Romosozumab
Treatment: Drugs - Placebo to Alendronate

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.

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.


Treatment: Other: Romosozumab
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

Treatment: Drugs: Alendronate
Alendronate 70 mg tablet taken once a week

Treatment: Drugs: Placebo to Romosozumab
Administered by subcutaneous injection once a month during the double-blind treatment phase.

Treatment: Drugs: Placebo to Alendronate
Matching placebo tablet taken once a week during the double-blind treatment phase.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 24
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Percentage of Participants With a Clinical Fracture at the Primary Analysis
Timepoint [2] 0 0
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 [1] 0 0
Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
Timepoint [1] 0 0
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 [2] 0 0
Percentage of Participants With Any Fracture at the Primary Analysis
Timepoint [2] 0 0
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 [3] 0 0
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis
Timepoint [4] 0 0
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 [5] 0 0
Percentage of Participants With a Hip Fracture at the Primary Analysis
Timepoint [5] 0 0
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 [6] 0 0
Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Percentage of Participants With a Clinical Fracture Through Month 24
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Percentage of Participants With a Nonvertebral Fracture Through Month 24
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Percentage of Participants With a Hip Fracture Through Month 24
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Percentage of Participants With a Clinical Vertebral Fracture Through Month 24
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Percentage of Participants With a Clinical Fracture Through Month 12
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 12
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Percentage of Participants With Any Fracture Through Month 12
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Percentage of Participants With a Nonvertebral Fracture Through Month 12
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Percentage of Participants With a Hip Fracture Through Month 12
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Percentage of Participants With a Clinical Vertebral Fracture Through Month 12
Timepoint [17] 0 0
12 months
Secondary outcome [18] 0 0
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24
Timepoint [18] 0 0
Baseline and month 24
Secondary outcome [19] 0 0
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
Timepoint [19] 0 0
Baseline and month 24
Secondary outcome [20] 0 0
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24
Timepoint [20] 0 0
Baseline and month 24
Secondary outcome [21] 0 0
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
Timepoint [21] 0 0
Baseline and month 12
Secondary outcome [22] 0 0
Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
Timepoint [22] 0 0
Baseline and month 12
Secondary outcome [23] 0 0
Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
Timepoint [23] 0 0
Baseline and month 12
Secondary outcome [24] 0 0
Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36
Timepoint [24] 0 0
Baseline and month 36
Secondary outcome [25] 0 0
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36
Timepoint [25] 0 0
Baseline and month 36
Secondary outcome [26] 0 0
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36
Timepoint [26] 0 0
Baseline and month 36

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2017
Sample size
Target
Accrual to date
Final
4093
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment hospital [4] 0 0
Research Site - Box Hill
Recruitment hospital [5] 0 0
Research Site - Geelong
Recruitment hospital [6] 0 0
Research Site - Heidelberg West
Recruitment hospital [7] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Córdoba
Country [23] 0 0
Austria
State/province [23] 0 0
Graz
Country [24] 0 0
Austria
State/province [24] 0 0
Linz
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Belgium
State/province [26] 0 0
Brugge
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
Country [28] 0 0
Belgium
State/province [28] 0 0
Genk
Country [29] 0 0
Belgium
State/province [29] 0 0
Gent
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven
Country [31] 0 0
Belgium
State/province [31] 0 0
Liège
Country [32] 0 0
Brazil
State/province [32] 0 0
Ceará
Country [33] 0 0
Brazil
State/province [33] 0 0
Distrito Federal
Country [34] 0 0
Brazil
State/province [34] 0 0
Espírito Santo
Country [35] 0 0
Brazil
State/province [35] 0 0
Goiás
Country [36] 0 0
Brazil
State/province [36] 0 0
Paraná
Country [37] 0 0
Brazil
State/province [37] 0 0
Pernambuco
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio de Janeiro
Country [39] 0 0
Brazil
State/province [39] 0 0
São Paulo
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Plovdiv
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Sofia
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Manitoba
Country [44] 0 0
Canada
State/province [44] 0 0
Newfoundland and Labrador
Country [45] 0 0
Canada
State/province [45] 0 0
Nova Scotia
Country [46] 0 0
Canada
State/province [46] 0 0
Ontario
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Chile
State/province [48] 0 0
Santiago
Country [49] 0 0
Colombia
State/province [49] 0 0
Antioquia
Country [50] 0 0
Colombia
State/province [50] 0 0
Atlántico
Country [51] 0 0
Colombia
State/province [51] 0 0
Cundinamarca
Country [52] 0 0
Colombia
State/province [52] 0 0
Bogota
Country [53] 0 0
Colombia
State/province [53] 0 0
Bucaramanga
Country [54] 0 0
Czechia
State/province [54] 0 0
Brno
Country [55] 0 0
Czechia
State/province [55] 0 0
Hradec Kralove
Country [56] 0 0
Czechia
State/province [56] 0 0
Klatovy
Country [57] 0 0
Czechia
State/province [57] 0 0
Opava
Country [58] 0 0
Czechia
State/province [58] 0 0
Ostrava-Trebovice
Country [59] 0 0
Czechia
State/province [59] 0 0
Pardubice
Country [60] 0 0
Czechia
State/province [60] 0 0
Plzen
Country [61] 0 0
Czechia
State/province [61] 0 0
Praha 2
Country [62] 0 0
Czechia
State/province [62] 0 0
Praha 3
Country [63] 0 0
Czechia
State/province [63] 0 0
Uherske Hradiste
Country [64] 0 0
Czechia
State/province [64] 0 0
Zlin
Country [65] 0 0
Denmark
State/province [65] 0 0
Aalborg
Country [66] 0 0
Denmark
State/province [66] 0 0
Ballerup
Country [67] 0 0
Denmark
State/province [67] 0 0
Glostrup
Country [68] 0 0
Denmark
State/province [68] 0 0
Hvidovre
Country [69] 0 0
Denmark
State/province [69] 0 0
Koge
Country [70] 0 0
Denmark
State/province [70] 0 0
Odense
Country [71] 0 0
Denmark
State/province [71] 0 0
Vejle
Country [72] 0 0
Denmark
State/province [72] 0 0
Århus C
Country [73] 0 0
Dominican Republic
State/province [73] 0 0
Distrito Nacional
Country [74] 0 0
Dominican Republic
State/province [74] 0 0
Santiago
Country [75] 0 0
Dominican Republic
State/province [75] 0 0
Santo Domingo
Country [76] 0 0
Estonia
State/province [76] 0 0
Tallinn
Country [77] 0 0
Estonia
State/province [77] 0 0
Tartu
Country [78] 0 0
Finland
State/province [78] 0 0
Helsinki
Country [79] 0 0
Finland
State/province [79] 0 0
Jyväskylä
Country [80] 0 0
Finland
State/province [80] 0 0
Kuopio
Country [81] 0 0
Finland
State/province [81] 0 0
Turku
Country [82] 0 0
France
State/province [82] 0 0
Bordeaux Cedex
Country [83] 0 0
France
State/province [83] 0 0
Cahors Cedex
Country [84] 0 0
France
State/province [84] 0 0
Lille cedex
Country [85] 0 0
France
State/province [85] 0 0
Lyon Cédex 3
Country [86] 0 0
France
State/province [86] 0 0
Orleans Cedex
Country [87] 0 0
France
State/province [87] 0 0
Saint Priest en Jarez
Country [88] 0 0
France
State/province [88] 0 0
Toulouse Cedex 9
Country [89] 0 0
France
State/province [89] 0 0
Vandoeuvre les Nancy
Country [90] 0 0
Germany
State/province [90] 0 0
Berlin (Hellersdorf)
Country [91] 0 0
Germany
State/province [91] 0 0
Berlin
Country [92] 0 0
Germany
State/province [92] 0 0
Bonn
Country [93] 0 0
Germany
State/province [93] 0 0
Dresden
Country [94] 0 0
Germany
State/province [94] 0 0
Frankfurt am Main
Country [95] 0 0
Germany
State/province [95] 0 0
Freiburg
Country [96] 0 0
Germany
State/province [96] 0 0
Hamburg
Country [97] 0 0
Germany
State/province [97] 0 0
Hannover
Country [98] 0 0
Germany
State/province [98] 0 0
Heinsberg
Country [99] 0 0
Germany
State/province [99] 0 0
Leipzig
Country [100] 0 0
Germany
State/province [100] 0 0
Magdeburg
Country [101] 0 0
Germany
State/province [101] 0 0
Marburg
Country [102] 0 0
Germany
State/province [102] 0 0
München
Country [103] 0 0
Germany
State/province [103] 0 0
Würzburg
Country [104] 0 0
Greece
State/province [104] 0 0
Athens
Country [105] 0 0
Greece
State/province [105] 0 0
Larissa
Country [106] 0 0
Greece
State/province [106] 0 0
Thessaloniki
Country [107] 0 0
Guatemala
State/province [107] 0 0
Sacatepéquez
Country [108] 0 0
Guatemala
State/province [108] 0 0
Guatemala
Country [109] 0 0
Hong Kong
State/province [109] 0 0
Hong Kong
Country [110] 0 0
Hong Kong
State/province [110] 0 0
New Territories
Country [111] 0 0
Hungary
State/province [111] 0 0
Balatonfured
Country [112] 0 0
Hungary
State/province [112] 0 0
Bekescsaba
Country [113] 0 0
Hungary
State/province [113] 0 0
Budapest
Country [114] 0 0
Hungary
State/province [114] 0 0
Debrecen
Country [115] 0 0
Hungary
State/province [115] 0 0
Gyor
Country [116] 0 0
Hungary
State/province [116] 0 0
Kaposvar
Country [117] 0 0
Hungary
State/province [117] 0 0
Kiskunhalas
Country [118] 0 0
Hungary
State/province [118] 0 0
Kistarcsa
Country [119] 0 0
Hungary
State/province [119] 0 0
Veszprem
Country [120] 0 0
Hungary
State/province [120] 0 0
Zalaegerszeg
Country [121] 0 0
Ireland
State/province [121] 0 0
Cork
Country [122] 0 0
Ireland
State/province [122] 0 0
Dublin
Country [123] 0 0
Ireland
State/province [123] 0 0
Galway
Country [124] 0 0
Israel
State/province [124] 0 0
Bnei Brak
Country [125] 0 0
Israel
State/province [125] 0 0
Haifa
Country [126] 0 0
Israel
State/province [126] 0 0
Jerusalem
Country [127] 0 0
Israel
State/province [127] 0 0
Tel Aviv
Country [128] 0 0
Italy
State/province [128] 0 0
Arenzano GE
Country [129] 0 0
Italy
State/province [129] 0 0
Bologna
Country [130] 0 0
Italy
State/province [130] 0 0
Catania
Country [131] 0 0
Italy
State/province [131] 0 0
Firenze
Country [132] 0 0
Italy
State/province [132] 0 0
Milan
Country [133] 0 0
Italy
State/province [133] 0 0
Pisa
Country [134] 0 0
Italy
State/province [134] 0 0
Roma
Country [135] 0 0
Italy
State/province [135] 0 0
Siena
Country [136] 0 0
Italy
State/province [136] 0 0
Torino
Country [137] 0 0
Italy
State/province [137] 0 0
Verona
Country [138] 0 0
Korea, Republic of
State/province [138] 0 0
Daegu
Country [139] 0 0
Korea, Republic of
State/province [139] 0 0
Guri-si
Country [140] 0 0
Korea, Republic of
State/province [140] 0 0
Gwangju
Country [141] 0 0
Korea, Republic of
State/province [141] 0 0
Incheon
Country [142] 0 0
Korea, Republic of
State/province [142] 0 0
Seoul
Country [143] 0 0
Korea, Republic of
State/province [143] 0 0
Suwon-si, Gyeonggi-do
Country [144] 0 0
Latvia
State/province [144] 0 0
Liepaja
Country [145] 0 0
Latvia
State/province [145] 0 0
Riga
Country [146] 0 0
Lithuania
State/province [146] 0 0
Vilnius
Country [147] 0 0
Mexico
State/province [147] 0 0
Baja California Norte
Country [148] 0 0
Mexico
State/province [148] 0 0
Distrito Federal
Country [149] 0 0
Mexico
State/province [149] 0 0
Guanajuato
Country [150] 0 0
Mexico
State/province [150] 0 0
Nuevo León
Country [151] 0 0
Mexico
State/province [151] 0 0
Querétaro
Country [152] 0 0
Mexico
State/province [152] 0 0
Sonora
Country [153] 0 0
Netherlands
State/province [153] 0 0
Leiden
Country [154] 0 0
Netherlands
State/province [154] 0 0
Rotterdam
Country [155] 0 0
Netherlands
State/province [155] 0 0
Venlo
Country [156] 0 0
New Zealand
State/province [156] 0 0
Christchurch
Country [157] 0 0
New Zealand
State/province [157] 0 0
Grafton, Auckland
Country [158] 0 0
Norway
State/province [158] 0 0
Elverum
Country [159] 0 0
Norway
State/province [159] 0 0
Hamar
Country [160] 0 0
Norway
State/province [160] 0 0
Oslo
Country [161] 0 0
Norway
State/province [161] 0 0
Stavanger
Country [162] 0 0
Peru
State/province [162] 0 0
Lima
Country [163] 0 0
Poland
State/province [163] 0 0
Bialystok
Country [164] 0 0
Poland
State/province [164] 0 0
Dabrowka Dopiewo
Country [165] 0 0
Poland
State/province [165] 0 0
Elblag
Country [166] 0 0
Poland
State/province [166] 0 0
Gdynia
Country [167] 0 0
Poland
State/province [167] 0 0
Gliwice
Country [168] 0 0
Poland
State/province [168] 0 0
Katowice
Country [169] 0 0
Poland
State/province [169] 0 0
Kielce
Country [170] 0 0
Poland
State/province [170] 0 0
Krakow
Country [171] 0 0
Poland
State/province [171] 0 0
Kraków
Country [172] 0 0
Poland
State/province [172] 0 0
Lodz
Country [173] 0 0
Poland
State/province [173] 0 0
Poznan
Country [174] 0 0
Poland
State/province [174] 0 0
Swidnik
Country [175] 0 0
Poland
State/province [175] 0 0
Torun
Country [176] 0 0
Poland
State/province [176] 0 0
Warszawa
Country [177] 0 0
Poland
State/province [177] 0 0
Wroclaw
Country [178] 0 0
Romania
State/province [178] 0 0
Bucharest
Country [179] 0 0
Romania
State/province [179] 0 0
Bucuresti
Country [180] 0 0
Romania
State/province [180] 0 0
Oradea
Country [181] 0 0
Romania
State/province [181] 0 0
Targu Mures
Country [182] 0 0
Russian Federation
State/province [182] 0 0
Arkhangelsk
Country [183] 0 0
Russian Federation
State/province [183] 0 0
Ekaterinburg
Country [184] 0 0
Russian Federation
State/province [184] 0 0
Ivanovo
Country [185] 0 0
Russian Federation
State/province [185] 0 0
Moscow
Country [186] 0 0
Russian Federation
State/province [186] 0 0
Nizhniy Novgorod
Country [187] 0 0
Russian Federation
State/province [187] 0 0
Petrozavodsk
Country [188] 0 0
Russian Federation
State/province [188] 0 0
Saint Petersburg
Country [189] 0 0
Russian Federation
State/province [189] 0 0
Saint-Petersburg
Country [190] 0 0
Russian Federation
State/province [190] 0 0
Yaroslavl
Country [191] 0 0
Slovakia
State/province [191] 0 0
Banska Bystrica
Country [192] 0 0
Slovakia
State/province [192] 0 0
Bratislava
Country [193] 0 0
Slovakia
State/province [193] 0 0
Kosice-Saca
Country [194] 0 0
Slovakia
State/province [194] 0 0
Lucenec
Country [195] 0 0
Slovakia
State/province [195] 0 0
Piestany
Country [196] 0 0
Slovakia
State/province [196] 0 0
Trencin
Country [197] 0 0
South Africa
State/province [197] 0 0
Gauteng
Country [198] 0 0
South Africa
State/province [198] 0 0
Western Cape
Country [199] 0 0
South Africa
State/province [199] 0 0
Tygerberg
Country [200] 0 0
Spain
State/province [200] 0 0
Andalucía
Country [201] 0 0
Spain
State/province [201] 0 0
Cantabria
Country [202] 0 0
Spain
State/province [202] 0 0
Cataluña
Country [203] 0 0
Spain
State/province [203] 0 0
Galicia
Country [204] 0 0
Spain
State/province [204] 0 0
Madrid
Country [205] 0 0
Sweden
State/province [205] 0 0
Linköping
Country [206] 0 0
Sweden
State/province [206] 0 0
Mölndal
Country [207] 0 0
Sweden
State/province [207] 0 0
Stockholm
Country [208] 0 0
Sweden
State/province [208] 0 0
Umeå
Country [209] 0 0
Taiwan
State/province [209] 0 0
Tainan
Country [210] 0 0
Taiwan
State/province [210] 0 0
Taipei
Country [211] 0 0
Turkey
State/province [211] 0 0
Adana
Country [212] 0 0
Turkey
State/province [212] 0 0
Istanbul
Country [213] 0 0
Turkey
State/province [213] 0 0
Izmir
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Birmingham
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Cambridge
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Cardiff
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Chorley
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Edinburgh
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Glasgow
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Liverpool
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Manchester
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Northwood
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Norwich
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Reading
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Sheffield
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Sidcup
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Staffordshire
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Warwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
Trial website
https://clinicaltrials.gov/study/NCT01631214
Trial related presentations / publications
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.
Brown 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.
Cosman 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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01631214