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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01732770
Registration number
NCT01732770
Ethics application status
Date submitted
20/11/2012
Date registered
26/11/2012
Date last updated
10/03/2020
Titles & IDs
Public title
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
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Scientific title
A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
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Secondary ID [1]
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2012-001821-28
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Secondary ID [2]
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20110153
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post Menopausal Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Reproductive Health and Childbirth
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Denosumab
Treatment: Drugs - Zoledronic Acid
Treatment: Drugs - Placebo to Denosumab
Treatment: Drugs - Placebo to Zoledronic Acid
Experimental: Denosumab 60 mg - Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
Active Comparator: Zoledronic Acid 5 mg - Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
Other interventions: Denosumab
Denosumab 60 mg administered by subcutaneous injection once every 6 months.
Treatment: Drugs: Zoledronic Acid
Zoledronic acid 5 mg administered by intravenous infusion once a year
Treatment: Drugs: Placebo to Denosumab
Administered by subcutaneous injection once every 6 months
Treatment: Drugs: Placebo to Zoledronic Acid
Administered by intravenous infusion once a year
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis
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Assessment method [1]
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Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.
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Timepoint [1]
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Baseline and Month 12
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Secondary outcome [1]
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Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis
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Assessment method [1]
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BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.
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Timepoint [1]
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Baseline and Month 12
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Secondary outcome [2]
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Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis
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Assessment method [2]
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Timepoint [2]
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Baseline and Month 12
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Secondary outcome [3]
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Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis
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Assessment method [3]
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Timepoint [3]
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Baseline and Month 12
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Eligibility
Key inclusion criteria
- Ambulatory postmenopausal women.
- Age 55 years or older
- Subject has provided informed consent prior to any study specific procedures
- Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to
screening visit
- Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of
equal to or less than those listed in the protocol.
- At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray
absorptiometry (DXA) at the screening visit
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Received other osteoporosis treatment or bone active treatment
- Evidence of history of any of the following:
- hyperthyroidism (stable on antithyroid therapy is allowed)
- hypothyroidism (stable on thyroid replacement therapy is allowed)
- hypo- or hyperparathyroidism
- hypo- or hypercalcemia based on the central laboratory reference ranges
- Recent tooth extraction (within 6 months of screening visit)
- Paget disease of bone (subject report or chart review)
- other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis
imperfecta) (chart review)
- Abnormalities of the following per central laboratory reference ranges:
- vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be
allowed and subjects may be re-screened
- hypercalcemia
- elevated transaminases = 2.0 x upper limits of normal (ULN)
- History of any solid organ or bone marrow transplant
- Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in
situ) within the last 5 years
- Known intolerance to calcium or vitamin D supplements
- Self-reported alcohol or drug abuse within 12 months prior to screening
- Currently receiving treatment in another investigational device or drug study, or less
than 30 days since ending treatment on another investigational device or drug study(s)
- History or evidence of any other clinically significant disorder, condition or disease
that in the opinion of the Investigator or Amgen physician, if consulted, would pose a
risk to subject safety or interfere with the study evaluation, procedures or
completion
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/01/2015
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Sample size
Target
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Accrual to date
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Final
643
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Research Site - Maroubra
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Research Site - Penrith
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Research Site - St Leonards
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Research Site - Box Hill
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Recruitment hospital [6]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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2750 - Penrith
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2065 - St Leonards
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Brussels
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Brussel
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Belgium
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Bruxelles
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Belgium
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Genk
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Leuven
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Liège
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Merksem
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Aalborg
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Bialystok
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Andalucía
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Cataluña
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Spain
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare the effectiveness of denosumab treatment every 6 months with once
yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01732770
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Trial related presentations / publications
Miller PD, Pannacciulli N, Brown JP, Czerwinski E, Nedergaard BS, Bolognese MA, Malouf J, Bone HG, Reginster JY, Singer A, Wang C, Wagman RB, Cummings SR. Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates. J Clin Endocrinol Metab. 2016 Aug;101(8):3163-70. doi: 10.1210/jc.2016-1801. Epub 2016 Jun 6.
Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.
Chotiyarnwong P, McCloskey E, Eastell R, McClung MR, Gielen E, Gostage J, McDermott M, Chines A, Huang S, Cummings SR. A Pooled Analysis of Fall Incidence From Placebo-Controlled Trials of Denosumab. J Bone Miner Res. 2020 Jun;35(6):1014-1021. doi: 10.1002/jbmr.3972. Epub 2020 Apr 2.
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Public notes
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Contacts
Principal investigator
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Address
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01732770
Download to PDF