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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01575834




Registration number
NCT01575834
Ethics application status
Date submitted
4/04/2012
Date registered
12/04/2012
Date last updated
28/08/2024

Titles & IDs
Public title
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Scientific title
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Secondary ID [1] 0 0
2011-001456-11
Secondary ID [2] 0 0
20070337
Universal Trial Number (UTN)
Trial acronym
FRAME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

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

Experimental: Romosozumab - Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

Placebo comparator: Placebo - Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.


Treatment: Drugs: Romosozumab
Administered by subcutaneous injection once a month (QM)

Treatment: Drugs: Placebo
Administered by subcutaneous injection once a month (QM)

Treatment: Drugs: Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of = -2.50)
Minimum age
55 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* BMD T-score of = -3.50 at the total hip or femoral neck
* History of hip fracture
* Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
* Use of agents affecting bone metabolism
* History of metabolic or bone disease (except osteoporosis)
* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
* Current, uncontrolled hyper- or hypoparathyroidism

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
15/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/12/2016
Sample size
Target
Accrual to date
Final
7180
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Maroubra
Recruitment hospital [2] 0 0
Research Site - St Leonards
Recruitment hospital [3] 0 0
Research Site - Herston
Recruitment hospital [4] 0 0
Research Site - Keswick
Recruitment hospital [5] 0 0
Research Site - Footscray
Recruitment hospital [6] 0 0
Research Site - Geelong
Recruitment hospital [7] 0 0
Research Site - Heidelberg West
Recruitment hospital [8] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5035 - Keswick
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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New Mexico
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United States of America
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North Carolina
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North Dakota
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Ohio
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Pennsylvania
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Texas
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Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Córdoba
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Belgium
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Bruxelles
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Genk
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Ghent
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Leuven
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Reading

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01575834