Trial Outcomes & Findings for A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density. (NCT NCT00330460)

NCT ID: NCT00330460

Last Updated: 2011-01-24

Results Overview

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1189 participants

Primary outcome timeframe

12 months

Results posted on

2011-01-24

Participant Flow

First Subject Enrolled: 26-Apr-2006 Last Subject Enrolled: 17-Nov-2006

Participant milestones

Participant milestones
Measure	Alendronate 70 mg QW	Denosumab 60 mg Q6M
Overall Study STARTED	595	594
Overall Study COMPLETED	553	561
Overall Study NOT COMPLETED	42	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Alendronate 70 mg QW	Denosumab 60 mg Q6M
Overall Study Physician Decision	1	0
Overall Study Adverse Event	10	8
Overall Study Withdrawal by Subject	18	17
Overall Study Death	1	1
Overall Study Ineligibility determined	1	3
Overall Study Lost to Follow-up	8	3
Overall Study Noncompliance	2	1
Overall Study Other	1	0

Baseline Characteristics

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alendronate 70 mg QW n=595 Participants	Denosumab 60 mg Q6M n=594 Participants	Total n=1189 Participants Total of all reporting groups
Age Continuous	64.6 Years STANDARD_DEVIATION 8.3 • n=5 Participants	64.1 Years STANDARD_DEVIATION 8.6 • n=7 Participants	64.4 Years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	595 Participants n=5 Participants	594 Participants n=7 Participants	1189 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	502 Participants n=5 Participants	502 Participants n=7 Participants	1004 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	69 Participants n=5 Participants	66 Participants n=7 Participants	135 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Randomized subjects who have a nonmissing baseline and at least 1 nonmissing postbaseline evaluation at or prior to month 12. LOCF used as imputation method.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Outcome measures
Measure	Alendronate 70 mg QW n=572 Participants	Denosumab 60 mg Q6M n=579 Participants
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12	2.6 Percent Change from Baseline Interval 2.4 to 2.8	3.5 Percent Change from Baseline Interval 3.3 to 3.7

SECONDARY outcome

Timeframe: 12 months

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Outcome measures
Measure	Alendronate 70 mg QW n=571 Participants	Denosumab 60 mg Q6M n=579 Participants
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12	4.2 Percent Change from Baseline Interval 3.9 to 4.5	5.3 Percent Change from Baseline Interval 5.0 to 5.6

SECONDARY outcome

Timeframe: 12 months

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Outcome measures
Measure	Alendronate 70 mg QW n=572 Participants	Denosumab 60 mg Q6M n=579 Participants
Trochanter Bone Mineral Density Percent Change From Baseline at Month 12	3.4 Percent Change from Baseline Interval 3.1 to 3.7	4.5 Percent Change from Baseline Interval 4.1 to 4.8

SECONDARY outcome

Timeframe: 12 months

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Outcome measures
Measure	Alendronate 70 mg QW n=572 Participants	Denosumab 60 mg Q6M n=579 Participants
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12	1.8 Percent Change from Baseline Interval 1.5 to 2.1	2.4 Percent Change from Baseline Interval 2.2 to 2.7

SECONDARY outcome

Timeframe: 12 months

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Outcome measures
Measure	Alendronate 70 mg QW n=569 Participants	Denosumab 60 mg Q6M n=573 Participants
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12	0.6 Percent Change from Baseline Interval 0.3 to 0.8	1.1 Percent Change from Baseline Interval 0.9 to 1.4

Adverse Events

Alendronate 70 mg QW

Serious events: 37 serious events

Other events: 261 other events

Deaths: 0 deaths

Denosumab 60 mg Q6M

Serious events: 34 serious events

Other events: 270 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Alendronate 70 mg QW n=586 participants at risk	Denosumab 60 mg Q6M n=593 participants at risk
Gastrointestinal disorders Constipation	5.3% 31/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.1% 36/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	3.4% 20/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.1% 30/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dyspepsia	4.9% 29/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 34/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Influenza	7.2% 42/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.9% 41/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	7.3% 43/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.6% 45/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	4.3% 25/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.1% 36/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	9.6% 56/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.6% 75/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	9.6% 56/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 42/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	6.3% 37/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.2% 31/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	5.5% 32/586 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.1% 30/593 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

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