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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2012-001821-28
Secondary ID [2] 0 0
20110153
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Menopausal 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: Other - 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.


Treatment: Other: 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
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
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis
Timepoint [1] 0 0
Baseline and Month 12
Secondary outcome [1] 0 0
Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis
Timepoint [1] 0 0
Baseline and Month 12
Secondary outcome [2] 0 0
Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis
Timepoint [2] 0 0
Baseline and Month 12
Secondary outcome [3] 0 0
Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis
Timepoint [3] 0 0
Baseline and Month 12

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
Minimum age
55 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
7/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2015
Sample size
Target
Accrual to date
Final
643
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Maroubra
Recruitment hospital [2] 0 0
Research Site - Penrith
Recruitment hospital [3] 0 0
Research Site - St Leonards
Recruitment hospital [4] 0 0
Research Site - Box Hill
Recruitment hospital [5] 0 0
Research Site - Geelong
Recruitment hospital [6] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2750 - Penrith
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussel
Country [10] 0 0
Belgium
State/province [10] 0 0
Bruxelles
Country [11] 0 0
Belgium
State/province [11] 0 0
Genk
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Belgium
State/province [14] 0 0
Merksem
Country [15] 0 0
Belgium
State/province [15] 0 0
Tessenderlo
Country [16] 0 0
Belgium
State/province [16] 0 0
Wilrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
Yvoir
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Denmark
State/province [23] 0 0
Aalborg
Country [24] 0 0
Denmark
State/province [24] 0 0
Ballerup
Country [25] 0 0
Denmark
State/province [25] 0 0
Vejle
Country [26] 0 0
Poland
State/province [26] 0 0
Bialystok
Country [27] 0 0
Poland
State/province [27] 0 0
Kraków
Country [28] 0 0
Poland
State/province [28] 0 0
Torun
Country [29] 0 0
Poland
State/province [29] 0 0
Warszawa
Country [30] 0 0
Spain
State/province [30] 0 0
Andalucía
Country [31] 0 0
Spain
State/province [31] 0 0
Cataluña
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid

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/NCT01732770