Trial Outcomes & Findings for A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects (NCT NCT00306189)
NCT ID: NCT00306189
Last Updated: 2013-06-20
Results Overview
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
212 participants
Primary outcome timeframe
12 months
Results posted on
2013-06-20
Participant Flow
Participant milestones
| Measure |
Denosumab 14 mg Q6M
|
Denosumab 60 mg Q6M
|
Denosumab 100 mg Q6M
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
56
|
57
|
|
Overall Study
COMPLETED
|
48
|
50
|
45
|
52
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
11
|
5
|
Reasons for withdrawal
| Measure |
Denosumab 14 mg Q6M
|
Denosumab 60 mg Q6M
|
Denosumab 100 mg Q6M
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
3
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
8
|
1
|
|
Overall Study
Ineligibility determined
|
1
|
1
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
Baseline characteristics by cohort
| Measure |
Denosumab 14 mg Q6M
n=53 Participants
|
Denosumab 60 mg Q6M
n=54 Participants
|
Denosumab 100 mg Q6M
n=50 Participants
|
Placebo
n=55 Participants
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
65.9 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
65.1 Years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
64.6 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
64.6 Years
STANDARD_DEVIATION 7 • n=4 Participants
|
65.1 Years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All subjects who received \>= 1 dose of investigational product and have a baseline and \>= 1 post baseline measurement at the lumbar spine.
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Placebo
n=55 Participants
|
Denosumab 14 mg Q6M
n=53 Participants
|
Denosumab 60 mg Q6M
n=54 Participants
|
Denosumab 100 mg Q6M
n=50 Participants
|
|---|---|---|---|---|
|
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
|
.46 Percent Change from Baseline
Interval -0.23 to 1.15
|
5.71 Percent Change from Baseline
Interval 4.76 to 6.65
|
6.73 Percent Change from Baseline
Interval 5.71 to 7.75
|
7.45 Percent Change from Baseline
Interval 6.38 to 8.53
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Denosumab 14 mg Q6M
Serious events: 6 serious events
Other events: 50 other events
Deaths: 0 deaths
Denosumab 60 mg Q6M
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
Denosumab 100 mg Q6M
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=54 participants at risk
|
Denosumab 14 mg Q6M
n=53 participants at risk
|
Denosumab 60 mg Q6M
n=54 participants at risk
|
Denosumab 100 mg Q6M
n=51 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/54
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/51
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/54
|
1.9%
1/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/54
|
0.00%
0/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/54
|
1.9%
1/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/54
|
1.9%
1/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/54
|
0.00%
0/53
|
0.00%
0/54
|
2.0%
1/51
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/54
|
1.9%
1/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Infections and infestations
Hepatitis C
|
1.9%
1/54
|
0.00%
0/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/54
|
1.9%
1/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.9%
1/54
|
0.00%
0/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.9%
1/54
|
0.00%
0/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/54
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/54
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/51
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/54
|
0.00%
0/53
|
0.00%
0/54
|
2.0%
1/51
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/54
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/51
|
|
Vascular disorders
Hypotension
|
0.00%
0/54
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/51
|
|
Vascular disorders
Varicose vein
|
0.00%
0/54
|
1.9%
1/53
|
0.00%
0/54
|
0.00%
0/51
|
Other adverse events
| Measure |
Placebo
n=54 participants at risk
|
Denosumab 14 mg Q6M
n=53 participants at risk
|
Denosumab 60 mg Q6M
n=54 participants at risk
|
Denosumab 100 mg Q6M
n=51 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/54
|
0.00%
0/53
|
5.6%
3/54
|
2.0%
1/51
|
|
Eye disorders
Cataract
|
1.9%
1/54
|
5.7%
3/53
|
0.00%
0/54
|
2.0%
1/51
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54
|
9.4%
5/53
|
9.3%
5/54
|
3.9%
2/51
|
|
Gastrointestinal disorders
Dental caries
|
7.4%
4/54
|
1.9%
1/53
|
0.00%
0/54
|
2.0%
1/51
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
4/54
|
5.7%
3/53
|
3.7%
2/54
|
5.9%
3/51
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/54
|
1.9%
1/53
|
5.6%
3/54
|
0.00%
0/51
|
|
Gastrointestinal disorders
Gingivitis
|
1.9%
1/54
|
1.9%
1/53
|
5.6%
3/54
|
2.0%
1/51
|
|
Gastrointestinal disorders
Periodontitis
|
1.9%
1/54
|
0.00%
0/53
|
3.7%
2/54
|
5.9%
3/51
|
|
Gastrointestinal disorders
Stomach discomfort
|
5.6%
3/54
|
5.7%
3/53
|
0.00%
0/54
|
2.0%
1/51
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54
|
5.7%
3/53
|
0.00%
0/54
|
0.00%
0/51
|
|
General disorders
Malaise
|
9.3%
5/54
|
3.8%
2/53
|
1.9%
1/54
|
3.9%
2/51
|
|
Immune system disorders
Seasonal allergy
|
5.6%
3/54
|
0.00%
0/53
|
0.00%
0/54
|
2.0%
1/51
|
|
Infections and infestations
Bronchitis
|
0.00%
0/54
|
0.00%
0/53
|
5.6%
3/54
|
0.00%
0/51
|
|
Infections and infestations
Cystitis
|
5.6%
3/54
|
3.8%
2/53
|
3.7%
2/54
|
0.00%
0/51
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/54
|
5.7%
3/53
|
1.9%
1/54
|
3.9%
2/51
|
|
Infections and infestations
Herpes zoster
|
1.9%
1/54
|
7.5%
4/53
|
0.00%
0/54
|
0.00%
0/51
|
|
Infections and infestations
Hordeolum
|
1.9%
1/54
|
0.00%
0/53
|
0.00%
0/54
|
5.9%
3/51
|
|
Infections and infestations
Nasopharyngitis
|
38.9%
21/54
|
34.0%
18/53
|
40.7%
22/54
|
43.1%
22/51
|
|
Infections and infestations
Oral herpes
|
0.00%
0/54
|
5.7%
3/53
|
1.9%
1/54
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Contusion
|
14.8%
8/54
|
1.9%
1/53
|
7.4%
4/54
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Joint sprain
|
3.7%
2/54
|
1.9%
1/53
|
1.9%
1/54
|
9.8%
5/51
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/54
|
0.00%
0/53
|
3.7%
2/54
|
5.9%
3/51
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/54
|
7.5%
4/53
|
5.6%
3/54
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
4/54
|
5.7%
3/53
|
14.8%
8/54
|
17.6%
9/51
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/54
|
5.7%
3/53
|
3.7%
2/54
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.7%
2/54
|
7.5%
4/53
|
1.9%
1/54
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.6%
3/54
|
0.00%
0/53
|
3.7%
2/54
|
3.9%
2/51
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
4/54
|
3.8%
2/53
|
1.9%
1/54
|
3.9%
2/51
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
11.1%
6/54
|
1.9%
1/53
|
1.9%
1/54
|
2.0%
1/51
|
|
Nervous system disorders
Headache
|
9.3%
5/54
|
13.2%
7/53
|
11.1%
6/54
|
5.9%
3/51
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
3/54
|
1.9%
1/53
|
3.7%
2/54
|
9.8%
5/51
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/54
|
5.7%
3/53
|
1.9%
1/54
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
14.8%
8/54
|
7.5%
4/53
|
5.6%
3/54
|
11.8%
6/51
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.3%
5/54
|
11.3%
6/53
|
7.4%
4/54
|
11.8%
6/51
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/54
|
0.00%
0/53
|
1.9%
1/54
|
5.9%
3/51
|
|
Vascular disorders
Hypertension
|
1.9%
1/54
|
3.8%
2/53
|
5.6%
3/54
|
2.0%
1/51
|
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