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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
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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
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United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Illinois
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Indiana
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Maryland
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Massachusetts
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Michigan
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Argentina
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Graz
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Linz
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Brugge
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Genk
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Belgium
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Gent
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Belgium
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Leuven
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Liège
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Ceará
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Heinsberg
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Leipzig
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Marburg
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Athens
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Larissa
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Gyor
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Mexico
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Leiden
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Rotterdam
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Elverum
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Hamar
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Lima
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Kraków
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Torun
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Wroclaw
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Bucuresti
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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
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United Kingdom
State/province [220] 0 0
Liverpool
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Manchester
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United Kingdom
State/province [222] 0 0
Northwood
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Norwich
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United Kingdom
State/province [224] 0 0
Reading
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United Kingdom
State/province [225] 0 0
Sheffield
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United Kingdom
State/province [226] 0 0
Sidcup
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01631214