Trial Outcomes & Findings for Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis (NCT NCT00091793)
NCT ID: NCT00091793
Last Updated: 2010-12-31
Results Overview
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
332 participants
Primary outcome timeframe
24 Months
Results posted on
2010-12-31
Participant Flow
Participant milestones
| Measure |
Denosumab 60 mg Q6M
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
166
|
|
Overall Study
COMPLETED
|
142
|
144
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
Reasons for withdrawal
| Measure |
Denosumab 60 mg Q6M
|
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
15
|
|
Overall Study
Ineligibility determined
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Noncompliance
|
2
|
0
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Denosumab 60 mg Q6M
n=166 Participants
|
Placebo
n=166 Participants
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.8 Years
STANDARD_DEVIATION 7.4 • n=93 Participants
|
58.9 Years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
59.4 Years
STANDARD_DEVIATION 7.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=93 Participants
|
166 Participants
n=4 Participants
|
332 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: Randomized subjects who have a non-missing baseline and at least 1 non-missing postbaseline evaluation at or prior to month 24. LOCF was used as imputation method.
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=163 Participants
|
Placebo
n=163 Participants
|
|---|---|---|
|
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
|
6.5 Percent Change from Baseline
Interval 5.8 to 7.2
|
-.6 Percent Change from Baseline
Interval -1.2 to 0.1
|
SECONDARY outcome
Timeframe: 24 MonthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=163 Participants
|
Placebo
n=163 Participants
|
|---|---|---|
|
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
|
3.4 Percent Change from Baseline
Interval 3.0 to 3.7
|
-1.1 Percent Change from Baseline
Interval -1.5 to -0.8
|
SECONDARY outcome
Timeframe: 24 MonthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=163 Participants
|
Placebo
n=163 Participants
|
|---|---|---|
|
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
|
2.8 Percent Change from Baseline
Interval 2.3 to 3.3
|
-.9 Percent Change from Baseline
Interval -1.4 to -0.3
|
SECONDARY outcome
Timeframe: 24 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=163 Participants
|
Placebo
n=163 Participants
|
|---|---|---|
|
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
|
5.2 Percent Change from Baseline
Interval 4.7 to 5.6
|
-.8 Percent Change from Baseline
Interval -1.3 to -0.3
|
SECONDARY outcome
Timeframe: 24 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=156 Participants
|
Placebo
n=156 Participants
|
|---|---|---|
|
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
|
1.4 Percent Change from Baseline
Interval 0.9 to 1.9
|
-2.1 Percent Change from Baseline
Interval -2.6 to -1.6
|
SECONDARY outcome
Timeframe: 24 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=156 Participants
|
Placebo
n=154 Participants
|
|---|---|---|
|
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
|
2.4 Percent Change from Baseline
Interval 1.9 to 2.9
|
-1.4 Percent Change from Baseline
Interval -1.9 to -0.8
|
SECONDARY outcome
Timeframe: 24 monthsVolumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=144 Participants
|
Placebo
n=131 Participants
|
|---|---|---|
|
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
|
8.7 Percent Change from Baseline
Interval 3.0 to 14.4
|
-.7 Percent Change from Baseline
Interval -6.6 to 5.3
|
SECONDARY outcome
Timeframe: 24 monthsVolumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=156 Participants
|
Placebo
n=152 Participants
|
|---|---|---|
|
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
|
.3 Percent Change from Baseline
Interval -0.1 to 0.8
|
-1.4 Percent Change from Baseline
Interval -1.8 to -0.9
|
SECONDARY outcome
Timeframe: 24 monthsVolumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Outcome measures
| Measure |
Denosumab 60 mg Q6M
n=156 Participants
|
Placebo
n=153 Participants
|
|---|---|---|
|
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
|
.8 Percent Change from Baseline
Interval 0.0 to 1.6
|
-1.9 Percent Change from Baseline
Interval -2.6 to -1.1
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 157 other events
Deaths: 0 deaths
Denosumab 60 mg Q6M
Serious events: 18 serious events
Other events: 156 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=165 participants at risk
|
Denosumab 60 mg Q6M
n=164 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/165
|
0.61%
1/164
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Appendicitis
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Cellulitis
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/165
|
1.2%
2/164
|
|
Infections and infestations
Lobar pneumonia
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Pneumonia
|
0.00%
0/165
|
1.8%
3/164
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Sepsis
|
0.00%
0/165
|
1.2%
2/164
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/165
|
0.61%
1/164
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/165
|
0.61%
1/164
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/165
|
0.61%
1/164
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.61%
1/165
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.61%
1/165
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.61%
1/165
|
0.61%
1/164
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/165
|
1.2%
2/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.61%
1/165
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/165
|
0.61%
1/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.00%
0/165
|
0.61%
1/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/165
|
0.61%
1/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/165
|
0.61%
1/164
|
|
Nervous system disorders
Facial palsy
|
0.61%
1/165
|
0.00%
0/164
|
|
Psychiatric disorders
Depression
|
0.61%
1/165
|
0.00%
0/164
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/165
|
0.61%
1/164
|
|
Reproductive system and breast disorders
Uterine perforation
|
0.61%
1/165
|
0.00%
0/164
|
Other adverse events
| Measure |
Placebo
n=165 participants at risk
|
Denosumab 60 mg Q6M
n=164 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
5/165
|
6.7%
11/164
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.0%
5/165
|
9.1%
15/164
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
5/165
|
8.5%
14/164
|
|
Vascular disorders
Hypertension
|
8.5%
14/165
|
3.7%
6/164
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
7/165
|
5.5%
9/164
|
|
Gastrointestinal disorders
Constipation
|
4.8%
8/165
|
11.0%
18/164
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
7/165
|
8.5%
14/164
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
10/165
|
5.5%
9/164
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
6/165
|
5.5%
9/164
|
|
Gastrointestinal disorders
Nausea
|
7.3%
12/165
|
9.8%
16/164
|
|
General disorders
Fatigue
|
7.3%
12/165
|
4.3%
7/164
|
|
Infections and infestations
Influenza
|
10.9%
18/165
|
9.1%
15/164
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
31/165
|
22.0%
36/164
|
|
Infections and infestations
Sinusitis
|
10.3%
17/165
|
6.1%
10/164
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
22/165
|
11.6%
19/164
|
|
Infections and infestations
Urinary tract infection
|
10.3%
17/165
|
11.0%
18/164
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.0%
5/165
|
5.5%
9/164
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.5%
42/165
|
25.0%
41/164
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
33/165
|
20.1%
33/164
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.9%
13/165
|
7.3%
12/164
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
12/165
|
6.7%
11/164
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.1%
20/165
|
14.6%
24/164
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.1%
10/165
|
10.4%
17/164
|
|
Nervous system disorders
Dizziness
|
5.5%
9/165
|
4.3%
7/164
|
|
Nervous system disorders
Headache
|
11.5%
19/165
|
15.9%
26/164
|
|
Nervous system disorders
Hypoaesthesia
|
5.5%
9/165
|
3.0%
5/164
|
|
Psychiatric disorders
Depression
|
3.6%
6/165
|
6.1%
10/164
|
|
Psychiatric disorders
Insomnia
|
9.1%
15/165
|
7.9%
13/164
|
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