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AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00089661
Enrollment
252
Registered
2004-08-11
Start date
2004-10-01
Completion date
2009-05-27
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Low Bone Mineral Density, Osteopenia

Keywords

Breast Cancer, Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC, osteopenia, Low bone density

Brief summary

The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.

Interventions

DRUGPlacebo

60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

DRUGAMG 162 / Denosumab

60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically or cytologically confirmed adenocarcinoma of the breast * Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study * All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE) * Female \> 18 years of age * ECOG Performance status 0 and 1 * Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5 * Subject is willing and able to provide signed consent before any study-specific procedure Other criteria also apply.

Design outcomes

Primary

MeasureTime frameDescription
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 1212 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Secondary

MeasureTime frameDescription
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 66 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 1212 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 66 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 1212 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 66 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Participant flow

Participants by arm

ArmCount
Denosumab 60 mg Q6M127
Placebo125
Total252

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event02
Overall StudyDeath10
Overall StudyDisease progression13
Overall StudyIneligibility determined44
Overall StudyLost to Follow-up03
Overall StudyNoncompliance24
Overall StudyOther21
Overall StudyWithdrawal by Subject119

Baseline characteristics

CharacteristicDenosumab 60 mg Q6MPlaceboTotal
Age, Continuous59.2 Years
STANDARD_DEVIATION 8.9
59.7 Years
STANDARD_DEVIATION 9.7
59.5 Years
STANDARD_DEVIATION 9.3
Sex: Female, Male
Female
127 Participants125 Participants252 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
108 / 120117 / 129
serious
Total, serious adverse events
11 / 12019 / 129

Outcome results

Primary

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 12 months

Population: Subjects with non-missing baseline and \>= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Denosumab 60 mg Q6MLumbar Spine Bone Mineral Density Percent Change From Baseline at Month 124.8 Percent Change from Baseline
PlaceboLumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12-.7 Percent Change from Baseline
p-value: <0.000195% CI: [4.8, 6.3]ANCOVA
Secondary

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 12 months

ArmMeasureValue (LEAST_SQUARES_MEAN)
Denosumab 60 mg Q6MFemoral Neck Bone Mineral Density Percent Change From Baseline at Month 121.9 Percent Change from Baseline
PlaceboFemoral Neck Bone Mineral Density Percent Change From Baseline at Month 12-.6 Percent Change from Baseline
Secondary

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)
Denosumab 60 mg Q6MFemoral Neck Bone Mineral Density Percent Change From Baseline at Month 61.2 Percent Change from Baseline
PlaceboFemoral Neck Bone Mineral Density Percent Change From Baseline at Month 6-.9 Percent Change from Baseline
Secondary

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)
Denosumab 60 mg Q6MLumbar Spine Bone Mineral Density Percent Change From Baseline at Month 63.7 Percent Change from Baseline
PlaceboLumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6-.6 Percent Change from Baseline
Secondary

Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 12 months

ArmMeasureValue (LEAST_SQUARES_MEAN)
Denosumab 60 mg Q6MTotal Hip Bone Mineral Density Percent Change From Baseline at Month 123.1 Percent Change from Baseline
PlaceboTotal Hip Bone Mineral Density Percent Change From Baseline at Month 12-.7 Percent Change from Baseline
Secondary

Total Hip Bone Mineral Density Percent Change From Baseline at Month 6

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Time frame: 6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)
Denosumab 60 mg Q6MTotal Hip Bone Mineral Density Percent Change From Baseline at Month 62.3 Percent Change from Baseline
PlaceboTotal Hip Bone Mineral Density Percent Change From Baseline at Month 6-.4 Percent Change from Baseline

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026