Trial Outcomes & Findings for AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer (NCT NCT00089661)
NCT ID: NCT00089661
Last Updated: 2018-10-17
Results Overview
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
252 participants
Primary outcome timeframe
12 months
Results posted on
2018-10-17
Participant Flow
Participant milestones
| Measure |
Denosumab 60 mg Q6M
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
125
|
|
Overall Study
COMPLETED
|
106
|
99
|
|
Overall Study
NOT COMPLETED
|
21
|
26
|
Reasons for withdrawal
| Measure |
Denosumab 60 mg Q6M
|
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
11
|
9
|
|
Overall Study
Disease progression
|
1
|
3
|
|
Overall Study
Ineligibility determined
|
4
|
4
|
|
Overall Study
Noncompliance
|
2
|
4
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Denosumab 60 mg Q6M
n=127 Participants
|
Placebo
n=125 Participants
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
59.5 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Subjects with non-missing baseline and \>= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation.
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=123 Participants
|
Placebo
n=122 Participants
|
|---|---|---|
|
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
|
4.8 Percent Change from Baseline
Interval 4.3 to 5.4
|
-.7 Percent Change from Baseline
Interval -1.3 to -0.1
|
SECONDARY outcome
Timeframe: 6 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=123 Participants
|
Placebo
n=122 Participants
|
|---|---|---|
|
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6
|
3.7 Percent Change from Baseline
Interval 3.2 to 4.2
|
-.6 Percent Change from Baseline
Interval -1.1 to -0.1
|
SECONDARY outcome
Timeframe: 12 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=123 Participants
|
Placebo
n=122 Participants
|
|---|---|---|
|
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
|
3.1 Percent Change from Baseline
Interval 2.6 to 3.5
|
-.7 Percent Change from Baseline
Interval -1.1 to -0.2
|
SECONDARY outcome
Timeframe: 6 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=123 Participants
|
Placebo
n=122 Participants
|
|---|---|---|
|
Total Hip Bone Mineral Density Percent Change From Baseline at Month 6
|
2.3 Percent Change from Baseline
Interval 1.9 to 2.8
|
-.4 Percent Change from Baseline
Interval -0.8 to 0.1
|
SECONDARY outcome
Timeframe: 12 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=123 Participants
|
Placebo
n=122 Participants
|
|---|---|---|
|
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
|
1.9 Percent Change from Baseline
Interval 1.1 to 2.6
|
-.6 Percent Change from Baseline
Interval -1.4 to 0.2
|
SECONDARY outcome
Timeframe: 6 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=123 Participants
|
Placebo
n=122 Participants
|
|---|---|---|
|
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6
|
1.2 Percent Change from Baseline
Interval 0.5 to 1.9
|
-.9 Percent Change from Baseline
Interval -1.6 to -0.2
|
Adverse Events
Placebo
Serious events: 11 serious events
Other events: 108 other events
Deaths: 0 deaths
Denosumab 60 mg Q6M
Serious events: 19 serious events
Other events: 117 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=120 participants at risk
|
Denosumab 60 mg Q6M
n=129 participants at risk
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/120
|
0.78%
1/129
|
|
Cardiac disorders
Atrial fibrillation
|
0.83%
1/120
|
0.00%
0/129
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/120
|
0.78%
1/129
|
|
Cardiac disorders
Cardiac failure congestive
|
0.83%
1/120
|
0.00%
0/129
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/120
|
0.78%
1/129
|
|
Cardiac disorders
Myocardial ischaemia
|
0.83%
1/120
|
0.00%
0/129
|
|
Endocrine disorders
Goitre
|
0.83%
1/120
|
0.00%
0/129
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/120
|
0.78%
1/129
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/120
|
0.78%
1/129
|
|
Gastrointestinal disorders
Faecaloma
|
0.83%
1/120
|
0.00%
0/129
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/120
|
0.78%
1/129
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.83%
1/120
|
0.00%
0/129
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/120
|
0.78%
1/129
|
|
General disorders
Pelvic mass
|
0.00%
0/120
|
0.78%
1/129
|
|
Hepatobiliary disorders
Cholecystitis
|
0.83%
1/120
|
0.78%
1/129
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
2/120
|
0.00%
0/129
|
|
Infections and infestations
Cellulitis
|
0.00%
0/120
|
0.78%
1/129
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/120
|
0.78%
1/129
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/120
|
0.78%
1/129
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120
|
0.00%
0/129
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.83%
1/120
|
0.00%
0/129
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/120
|
0.78%
1/129
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.83%
1/120
|
0.00%
0/129
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.83%
1/120
|
0.78%
1/129
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/120
|
0.78%
1/129
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/120
|
1.6%
2/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.83%
1/120
|
0.00%
0/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/120
|
0.78%
1/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/120
|
0.78%
1/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/120
|
0.78%
1/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/120
|
0.78%
1/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/120
|
0.78%
1/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.83%
1/120
|
0.00%
0/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.83%
1/120
|
0.00%
0/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/120
|
0.78%
1/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/120
|
0.78%
1/129
|
|
Nervous system disorders
Transient ischaemic attack
|
0.83%
1/120
|
0.78%
1/129
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/120
|
0.78%
1/129
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.83%
1/120
|
0.00%
0/129
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.83%
1/120
|
0.00%
0/129
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/120
|
0.78%
1/129
|
Other adverse events
| Measure |
Placebo
n=120 participants at risk
|
Denosumab 60 mg Q6M
n=129 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
9.2%
11/120
|
11.6%
15/129
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
9/120
|
3.9%
5/129
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
8/120
|
1.6%
2/129
|
|
Gastrointestinal disorders
Nausea
|
9.2%
11/120
|
7.8%
10/129
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
6/120
|
6.2%
8/129
|
|
General disorders
Fatigue
|
14.2%
17/120
|
13.2%
17/129
|
|
General disorders
Oedema peripheral
|
4.2%
5/120
|
6.2%
8/129
|
|
Infections and infestations
Bronchitis
|
5.8%
7/120
|
3.9%
5/129
|
|
Infections and infestations
Sinusitis
|
3.3%
4/120
|
7.0%
9/129
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
6/120
|
7.8%
10/129
|
|
Infections and infestations
Urinary tract infection
|
4.2%
5/120
|
5.4%
7/129
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
30/120
|
24.0%
31/129
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
6/120
|
3.9%
5/129
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
15/120
|
14.0%
18/129
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
8/120
|
3.9%
5/129
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
6/120
|
5.4%
7/129
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
6/120
|
5.4%
7/129
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
5/120
|
8.5%
11/129
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.7%
14/120
|
14.7%
19/129
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.3%
4/120
|
8.5%
11/129
|
|
Nervous system disorders
Headache
|
7.5%
9/120
|
8.5%
11/129
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
4/120
|
5.4%
7/129
|
|
Psychiatric disorders
Anxiety
|
5.0%
6/120
|
6.2%
8/129
|
|
Psychiatric disorders
Depression
|
9.2%
11/120
|
5.4%
7/129
|
|
Psychiatric disorders
Insomnia
|
11.7%
14/120
|
9.3%
12/129
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
6/120
|
2.3%
3/129
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
2.5%
3/120
|
7.0%
9/129
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
5/120
|
10.1%
13/129
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
5/120
|
5.4%
7/129
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
6/120
|
7.8%
10/129
|
|
Vascular disorders
Hot flush
|
6.7%
8/120
|
5.4%
7/129
|
|
Vascular disorders
Hypertension
|
5.8%
7/120
|
1.6%
2/129
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER