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Trial record 1 of 1 for:    20040135
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AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00089661
Recruitment Status : Completed
First Posted : August 11, 2004
Results First Posted : January 26, 2010
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Breast Cancer
Low Bone Mineral Density
Osteopenia
Interventions Drug: Placebo
Drug: AMG 162 / Denosumab
Enrollment 252
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Denosumab 60 mg Q6M Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 127 125
Completed 106 99
Not Completed 21 26
Reason Not Completed
Adverse Event             0             2
Death             1             0
Lost to Follow-up             0             3
Withdrawal by Subject             11             9
Disease progression             1             3
Ineligibility determined             4             4
Noncompliance             2             4
Other             2             1
Arm/Group Title Denosumab 60 mg Q6M Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 127 125 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 125 participants 252 participants
59.2  (8.9) 59.7  (9.7) 59.5  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 125 participants 252 participants
Female
127
 100.0%
125
 100.0%
252
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with non-missing baseline and >= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation.
Arm/Group Title Denosumab 60 mg Q6M Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 123 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
4.8
(4.3 to 5.4)
-.7
(-1.3 to -.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Denosumab 60 mg Q6M, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.5
Confidence Interval 95%
4.8 to 6.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Denosumab 60 mg Q6M Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 123 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
3.7
(3.2 to 4.2)
-.6
(-1.1 to -.1)
3.Secondary Outcome
Title Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Denosumab 60 mg Q6M Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 123 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
3.1
(2.6 to 3.5)
-.7
(-1.1 to -.2)
4.Secondary Outcome
Title Total Hip Bone Mineral Density Percent Change From Baseline at Month 6
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Denosumab 60 mg Q6M Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 123 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
2.3
(1.9 to 2.8)
-.4
(-.8 to .1)
5.Secondary Outcome
Title Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Denosumab 60 mg Q6M Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 123 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
1.9
(1.1 to 2.6)
-.6
(-1.4 to .2)
6.Secondary Outcome
Title Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6
Hide Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Denosumab 60 mg Q6M Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 123 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
1.2
(.5 to 1.9)
-.9
(-1.6 to -.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Denosumab 60 mg Q6M
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Denosumab 60 mg Q6M
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Denosumab 60 mg Q6M
Affected / at Risk (%) Affected / at Risk (%)
Total   11/120 (9.17%)   19/129 (14.73%) 
Cardiac disorders     
Acute myocardial infarction  0/120 (0.00%)  1/129 (0.78%) 
Atrial fibrillation  1/120 (0.83%)  0/129 (0.00%) 
Atrioventricular block second degree  0/120 (0.00%)  1/129 (0.78%) 
Cardiac failure congestive  1/120 (0.83%)  0/129 (0.00%) 
Myocardial infarction  0/120 (0.00%)  1/129 (0.78%) 
Myocardial ischaemia  1/120 (0.83%)  0/129 (0.00%) 
Endocrine disorders     
Goitre  1/120 (0.83%)  0/129 (0.00%) 
Gastrointestinal disorders     
Colitis ischaemic  0/120 (0.00%)  1/129 (0.78%) 
Diverticulum  0/120 (0.00%)  1/129 (0.78%) 
Faecaloma  1/120 (0.83%)  0/129 (0.00%) 
Gastrointestinal haemorrhage  0/120 (0.00%)  1/129 (0.78%) 
Large intestine perforation  1/120 (0.83%)  0/129 (0.00%) 
Small intestinal obstruction  0/120 (0.00%)  1/129 (0.78%) 
General disorders     
Pelvic mass  0/120 (0.00%)  1/129 (0.78%) 
Hepatobiliary disorders     
Cholecystitis  1/120 (0.83%)  1/129 (0.78%) 
Cholelithiasis  2/120 (1.67%)  0/129 (0.00%) 
Infections and infestations     
Cellulitis  0/120 (0.00%)  1/129 (0.78%) 
Diverticulitis  0/120 (0.00%)  1/129 (0.78%) 
Labyrinthitis  0/120 (0.00%)  1/129 (0.78%) 
Pneumonia  1/120 (0.83%)  0/129 (0.00%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1/120 (0.83%)  0/129 (0.00%) 
Fracture  0/120 (0.00%)  1/129 (0.78%) 
Incisional hernia  1/120 (0.83%)  0/129 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1/120 (0.83%)  1/129 (0.78%) 
Intervertebral disc protrusion  0/120 (0.00%)  1/129 (0.78%) 
Osteoarthritis  0/120 (0.00%)  2/129 (1.55%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign breast neoplasm  1/120 (0.83%)  0/129 (0.00%) 
Benign ovarian tumour  0/120 (0.00%)  1/129 (0.78%) 
Breast cancer in situ  0/120 (0.00%)  1/129 (0.78%) 
Breast cancer metastatic  0/120 (0.00%)  1/129 (0.78%) 
Colon adenoma  0/120 (0.00%)  1/129 (0.78%) 
Malignant pleural effusion  0/120 (0.00%)  1/129 (0.78%) 
Metastases to bone  1/120 (0.83%)  0/129 (0.00%) 
Metastases to liver  1/120 (0.83%)  0/129 (0.00%) 
Metastatic neoplasm  0/120 (0.00%)  1/129 (0.78%) 
Uterine leiomyoma  0/120 (0.00%)  1/129 (0.78%) 
Nervous system disorders     
Transient ischaemic attack  1/120 (0.83%)  1/129 (0.78%) 
Reproductive system and breast disorders     
Rectocele  0/120 (0.00%)  1/129 (0.78%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1/120 (0.83%)  0/129 (0.00%) 
Pneumonitis  1/120 (0.83%)  0/129 (0.00%) 
Respiratory failure  0/120 (0.00%)  1/129 (0.78%) 
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Denosumab 60 mg Q6M
Affected / at Risk (%) Affected / at Risk (%)
Total   108/120 (90.00%)   117/129 (90.70%) 
Gastrointestinal disorders     
Constipation  11/120 (9.17%)  15/129 (11.63%) 
Diarrhoea  9/120 (7.50%)  5/129 (3.88%) 
Gastrooesophageal reflux disease  8/120 (6.67%)  2/129 (1.55%) 
Nausea  11/120 (9.17%)  10/129 (7.75%) 
Vomiting  6/120 (5.00%)  8/129 (6.20%) 
General disorders     
Fatigue  17/120 (14.17%)  17/129 (13.18%) 
Oedema peripheral  5/120 (4.17%)  8/129 (6.20%) 
Infections and infestations     
Bronchitis  7/120 (5.83%)  5/129 (3.88%) 
Sinusitis  4/120 (3.33%)  9/129 (6.98%) 
Upper respiratory tract infection  6/120 (5.00%)  10/129 (7.75%) 
Urinary tract infection  5/120 (4.17%)  7/129 (5.43%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  30/120 (25.00%)  31/129 (24.03%) 
Arthritis  6/120 (5.00%)  5/129 (3.88%) 
Back pain  15/120 (12.50%)  18/129 (13.95%) 
Bone pain  8/120 (6.67%)  5/129 (3.88%) 
Muscle spasms  6/120 (5.00%)  7/129 (5.43%) 
Musculoskeletal chest pain  6/120 (5.00%)  7/129 (5.43%) 
Myalgia  5/120 (4.17%)  11/129 (8.53%) 
Pain in extremity  14/120 (11.67%)  19/129 (14.73%) 
Shoulder pain  4/120 (3.33%)  11/129 (8.53%) 
Nervous system disorders     
Headache  9/120 (7.50%)  11/129 (8.53%) 
Hypoaesthesia  4/120 (3.33%)  7/129 (5.43%) 
Psychiatric disorders     
Anxiety  6/120 (5.00%)  8/129 (6.20%) 
Depression  11/120 (9.17%)  7/129 (5.43%) 
Insomnia  14/120 (11.67%)  12/129 (9.30%) 
Reproductive system and breast disorders     
Breast pain  6/120 (5.00%)  3/129 (2.33%) 
Vulvovaginal dryness  3/120 (2.50%)  9/129 (6.98%) 
Respiratory, thoracic and mediastinal disorders     
Cough  5/120 (4.17%)  13/129 (10.08%) 
Dyspnoea  5/120 (4.17%)  7/129 (5.43%) 
Skin and subcutaneous tissue disorders     
Rash  6/120 (5.00%)  10/129 (7.75%) 
Vascular disorders     
Hot flush  8/120 (6.67%)  7/129 (5.43%) 
Hypertension  7/120 (5.83%)  2/129 (1.55%) 
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089661    
Other Study ID Numbers: 20040135
First Submitted: August 9, 2004
First Posted: August 11, 2004
Results First Submitted: December 22, 2009
Results First Posted: January 26, 2010
Last Update Posted: October 17, 2018