Trial Outcomes & Findings for A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density (NCT NCT00293813)
NCT ID: NCT00293813
Last Updated: 2014-07-25
Results Overview
Cortical Thickness measured by XtremeCT.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
247 participants
Primary outcome timeframe
12 months
Results posted on
2014-07-25
Participant Flow
Participant milestones
| Measure |
Alendronate 70 mg QW
Alendronate 70 mg QW
|
Denosumab 60 mg Q6M
Denosumab 60 mg Q6M
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
82
|
|
Overall Study
COMPLETED
|
69
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
8
|
Reasons for withdrawal
| Measure |
Alendronate 70 mg QW
Alendronate 70 mg QW
|
Denosumab 60 mg Q6M
Denosumab 60 mg Q6M
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
3
|
|
Overall Study
Noncompliance
|
0
|
1
|
0
|
Baseline Characteristics
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Baseline characteristics by cohort
| Measure |
Alendronate 70 mg QW
n=82 Participants
Alendronate 70 mg QW
|
Denosumab 60 mg Q6M
n=83 Participants
Denosumab 60 mg Q6M
|
Placebo
n=82 Participants
Placebo
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.7 Years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
60.3 Years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
60.8 Years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
60.6 Years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
247 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Randomized subjects who receive at least 1 dose of investigational product and have a baseline and at least 1 post baseline evaluation before or at month 12. Last Observation Carried Forward used as imputation method. Summarised for actual treatment taken.
Cortical Thickness measured by XtremeCT.
Outcome measures
| Measure |
Alendronate 70 mg QW
n=73 Participants
Alendronate 70 mg QW
|
Denosumab 60 mg Q6M
n=75 Participants
Denosumab 60 mg Q6M
|
Placebo
n=79 Participants
Placebo
|
|---|---|---|---|
|
Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
|
2.4 Percent Change from Baseline
Interval 1.2 to 3.5
|
3.4 Percent Change from Baseline
Interval 2.2 to 4.5
|
-.8 Percent Change from Baseline
Interval -1.8 to 0.3
|
SECONDARY outcome
Timeframe: 12 monthsCortical Thickness measured by XtremeCT.
Outcome measures
| Measure |
Alendronate 70 mg QW
n=73 Participants
Alendronate 70 mg QW
|
Denosumab 60 mg Q6M
n=78 Participants
Denosumab 60 mg Q6M
|
Placebo
n=79 Participants
Placebo
|
|---|---|---|---|
|
Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
|
4.9 Percent Change from Baseline
Interval 4.0 to 5.8
|
5.8 Percent Change from Baseline
Interval 5.0 to 6.7
|
1.4 Percent Change from Baseline
Interval 0.6 to 2.3
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 78 other events
Deaths: 0 deaths
Alendronate 70 mg QW
Serious events: 5 serious events
Other events: 77 other events
Deaths: 0 deaths
Denosumab 60 mg Q6M
Serious events: 2 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=83 participants at risk
|
Alendronate 70 mg QW
n=81 participants at risk
|
Denosumab 60 mg Q6M
n=83 participants at risk
|
|---|---|---|---|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/83
|
1.2%
1/81
|
0.00%
0/83
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/83
|
0.00%
0/81
|
1.2%
1/83
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.4%
2/83
|
0.00%
0/81
|
0.00%
0/83
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83
|
0.00%
0/81
|
0.00%
0/83
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/83
|
0.00%
0/81
|
1.2%
1/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/83
|
1.2%
1/81
|
0.00%
0/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/83
|
2.5%
2/81
|
0.00%
0/83
|
|
Nervous system disorders
Amnesia
|
1.2%
1/83
|
0.00%
0/81
|
0.00%
0/83
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/83
|
1.2%
1/81
|
1.2%
1/83
|
|
Psychiatric disorders
Confusional state
|
1.2%
1/83
|
0.00%
0/81
|
0.00%
0/83
|
Other adverse events
| Measure |
Placebo
n=83 participants at risk
|
Alendronate 70 mg QW
n=81 participants at risk
|
Denosumab 60 mg Q6M
n=83 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
3/83
|
11.1%
9/81
|
2.4%
2/83
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
8/83
|
12.3%
10/81
|
6.0%
5/83
|
|
Gastrointestinal disorders
Constipation
|
14.5%
12/83
|
16.0%
13/81
|
18.1%
15/83
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
9/83
|
12.3%
10/81
|
3.6%
3/83
|
|
Gastrointestinal disorders
Dyspepsia
|
8.4%
7/83
|
11.1%
9/81
|
6.0%
5/83
|
|
Gastrointestinal disorders
Nausea
|
7.2%
6/83
|
6.2%
5/81
|
7.2%
6/83
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
5/83
|
7.4%
6/81
|
3.6%
3/83
|
|
Infections and infestations
Bronchitis
|
13.3%
11/83
|
13.6%
11/81
|
10.8%
9/83
|
|
Infections and infestations
Influenza
|
18.1%
15/83
|
12.3%
10/81
|
16.9%
14/83
|
|
Infections and infestations
Nasopharyngitis
|
16.9%
14/83
|
9.9%
8/81
|
12.0%
10/83
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/83
|
8.6%
7/81
|
7.2%
6/83
|
|
Infections and infestations
Urinary tract infection
|
6.0%
5/83
|
0.00%
0/81
|
4.8%
4/83
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
8/83
|
9.9%
8/81
|
12.0%
10/83
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
10/83
|
7.4%
6/81
|
12.0%
10/83
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
5/83
|
2.5%
2/81
|
6.0%
5/83
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/83
|
8.6%
7/81
|
4.8%
4/83
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.0%
5/83
|
2.5%
2/81
|
3.6%
3/83
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
10/83
|
12.3%
10/81
|
12.0%
10/83
|
|
Nervous system disorders
Dizziness
|
4.8%
4/83
|
4.9%
4/81
|
7.2%
6/83
|
|
Nervous system disorders
Headache
|
10.8%
9/83
|
14.8%
12/81
|
7.2%
6/83
|
|
Nervous system disorders
Paraesthesia
|
2.4%
2/83
|
4.9%
4/81
|
6.0%
5/83
|
|
Reproductive system and breast disorders
Breast mass
|
3.6%
3/83
|
2.5%
2/81
|
6.0%
5/83
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
5/83
|
4.9%
4/81
|
2.4%
2/83
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/83
|
2.5%
2/81
|
7.2%
6/83
|
|
Vascular disorders
Hypertension
|
7.2%
6/83
|
6.2%
5/81
|
6.0%
5/83
|
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