TriangleNCT00556374 · 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
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.
Bone mineral density was assessed by dual x-ray absorptiometry.
Bone mineral density was assessed by dual x-ray absorptiometry.
Bone mineral density was assessed by dual x-ray absorptiometry.
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.
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.
Reported safety
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-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-fareston-72758499
- 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