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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01631214
Ethics application status
Date submitted
24/05/2012
Date registered
29/06/2012
Date last updated
17/12/2018

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
Other interventions - 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.


Other interventions: 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
Other interventions
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 - 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.
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
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.
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 - 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.
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 - 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.
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 - 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.
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis - 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.
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 - Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
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 - 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.
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Percentage of Participants With a Clinical Fracture Through Month 24 - 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.
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Percentage of Participants With a Nonvertebral Fracture Through Month 24 - 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.
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Percentage of Participants With a Hip Fracture Through Month 24 - Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Percentage of Participants With a Clinical Vertebral Fracture Through Month 24 - 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.
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Percentage of Participants With a Clinical Fracture Through Month 12 - 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.
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 12 - New vertebral fractures occurred when there was = 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method 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.
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Percentage of Participants With Any Fracture Through Month 12 - 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.
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Percentage of Participants With a Nonvertebral Fracture Through Month 12 - 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.
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Percentage of Participants With a Hip Fracture Through Month 12 - Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Percentage of Participants With a Major Osteoporotic Fracture Through Month 12 - 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.
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Percentage of Participants With a Clinical Vertebral Fracture Through Month 12 - 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.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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 - Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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/show/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.
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
Other publications