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← Stage IV Breast Cancer

NCT00556374 · STUDY IN CONTEXT

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The time to first on-study clinical fracture was defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.

Full Analysis Set: all randomized participants

→

secondary · POSTED

Bone mineral density was assessed by dual x-ray absorptiometry.

BMD Analysis Set: all participants with evaluable lumbar spine BMD values at Baseline and Month 36

→

secondary · POSTED

Bone mineral density was assessed by dual x-ray absorptiometry.

BMD Analysis Set: all participants with total hip BMD evaluable values at Baseline and Month 36

→

secondary · POSTED

Bone mineral density was assessed by dual x-ray absorptiometry.

BMD Analysis Set: all participants with evaluable femoral neck BMD values at Baseline and Month 36

→

secondary · POSTED

Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays.

Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36

→

secondary · POSTED

Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures was defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.

Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-stage-iv-e69d3614
nct id
NCT00556374
trial label
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0000
    source section id
    NCT00556374-om-0000
    source outcome index
    0
    endpoint
    Time to First Clinical Fracture
    endpoint definition
    The time to first on-study clinical fracture was defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.
    time origin
    From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set: all randomized participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0001
    source section id
    NCT00556374-om-0001
    source outcome index
    1
    endpoint
    Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites
    endpoint definition
    Bone mineral density was assessed by dual x-ray absorptiometry.
    time origin
    Baseline and Month 36
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    BMD Analysis Set: all participants with evaluable lumbar spine BMD values at Baseline and Month 36
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0002
    source section id
    NCT00556374-om-0002
    source outcome index
    2
    endpoint
    Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites
    endpoint definition
    Bone mineral density was assessed by dual x-ray absorptiometry.
    time origin
    Baseline and Month 36
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    BMD Analysis Set: all participants with total hip BMD evaluable values at Baseline and Month 36
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0003
    source section id
    NCT00556374-om-0003
    source outcome index
    3
    endpoint
    Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites
    endpoint definition
    Bone mineral density was assessed by dual x-ray absorptiometry.
    time origin
    Baseline and Month 36
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    BMD Analysis Set: all participants with evaluable femoral neck BMD values at Baseline and Month 36
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0004
    source section id
    NCT00556374-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With New Vertebral Fractures
    endpoint definition
    Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays.
    time origin
    36 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0005
    source section id
    NCT00556374-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With New or Worsening Vertebral Fractures
    endpoint definition
    Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures was defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.
    time origin
    36 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo
    regimen
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    1709
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Denosumab
    regimen
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    1711
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo
    regimen
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    245
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Denosumab
    regimen
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Placebo
    regimen
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    237
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Denosumab
    regimen
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    231
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Placebo
    regimen
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    238
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Denosumab
    regimen
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    231
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Placebo
    regimen
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    809
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Denosumab
    regimen
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    835
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Placebo
    regimen
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    809
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Denosumab
    regimen
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    analyzed count
    835
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00556374-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    harm key
    EG000
    source section id
    NCT00556374-ae
    event group key
    EG000
    event group label
    Double-blind Phase: Placebo
    serious affected
    515
    serious at risk
    1690
    other affected
    838
    other at risk
    1690
    frequency threshold
    5
    collection period
    Double-blind (DB) phase: from 1st dose of study drug to 30 days after last dose; Open-label (OL) phase: from 1st dose of OL study drug to 30 days after last dose. Median duration of treatment in DB phase: Placebo 35.4 months and denosumab 35.5 months. Median duration of treatment in OL phase: 37 months
    event definition
    All randomized participants who received \>1 dose of treatment; participants were analyzed according to the actual treatment received in double-blind phase. 9 participants randomized to the placebo in the DB phase incorrectly received denosumab. Per protocol, only AEs of special interest and SAEs were collected in the open-label phase. MedDRA 17.1 used in double-blind phase and 24.0 in the open-label phase.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    harm key
    EG001
    source section id
    NCT00556374-ae
    event group key
    EG001
    event group label
    Double-blind Phase: Denosumab
    serious affected
    521
    serious at risk
    1709
    other affected
    882
    other at risk
    1709
    frequency threshold
    5
    collection period
    Double-blind (DB) phase: from 1st dose of study drug to 30 days after last dose; Open-label (OL) phase: from 1st dose of OL study drug to 30 days after last dose. Median duration of treatment in DB phase: Placebo 35.4 months and denosumab 35.5 months. Median duration of treatment in OL phase: 37 months
    event definition
    All randomized participants who received \>1 dose of treatment; participants were analyzed according to the actual treatment received in double-blind phase. 9 participants randomized to the placebo in the DB phase incorrectly received denosumab. Per protocol, only AEs of special interest and SAEs were collected in the open-label phase. MedDRA 17.1 used in double-blind phase and 24.0 in the open-label phase.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    harm key
    EG002
    source section id
    NCT00556374-ae
    event group key
    EG002
    event group label
    Open-label Phase: Placebo/Denosumab
    serious affected
    40
    serious at risk
    245
    other affected
    0
    other at risk
    245
    frequency threshold
    5
    collection period
    Double-blind (DB) phase: from 1st dose of study drug to 30 days after last dose; Open-label (OL) phase: from 1st dose of OL study drug to 30 days after last dose. Median duration of treatment in DB phase: Placebo 35.4 months and denosumab 35.5 months. Median duration of treatment in OL phase: 37 months
    event definition
    All randomized participants who received \>1 dose of treatment; participants were analyzed according to the actual treatment received in double-blind phase. 9 participants randomized to the placebo in the DB phase incorrectly received denosumab. Per protocol, only AEs of special interest and SAEs were collected in the open-label phase. MedDRA 17.1 used in double-blind phase and 24.0 in the open-label phase.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00556374
    harm key
    EG003
    source section id
    NCT00556374-ae
    event group key
    EG003
    event group label
    Open-label Phase: Denosumab/Denosumab
    serious affected
    0
    serious at risk
    1
    other affected
    0
    other at risk
    1
    frequency threshold
    5
    collection period
    Double-blind (DB) phase: from 1st dose of study drug to 30 days after last dose; Open-label (OL) phase: from 1st dose of OL study drug to 30 days after last dose. Median duration of treatment in DB phase: Placebo 35.4 months and denosumab 35.5 months. Median duration of treatment in OL phase: 37 months
    event definition
    All randomized participants who received \>1 dose of treatment; participants were analyzed according to the actual treatment received in double-blind phase. 9 participants randomized to the placebo in the DB phase incorrectly received denosumab. Per protocol, only AEs of special interest and SAEs were collected in the open-label phase. MedDRA 17.1 used in double-blind phase and 24.0 in the open-label phase.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice