Trial Outcomes & Findings for A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab (NCT NCT00890981)

NCT ID: NCT00890981

Last Updated: 2014-04-02

Results Overview

Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 79 participants
• Primary outcome timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
• Results posted on: 2014-04-02

Participant Flow

The first subject enrolled on 14-JUL-2009. The last subject enrolled on 12-MAY-2010

Participant milestones

Measure	Previous Placebo Treatment Group Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study.	Previous Denosumab Treatment Group Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Overall Study STARTED	39	40
Overall Study COMPLETED	39	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

Baseline characteristics by cohort

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.	Total n=79 Participants Total of all reporting groups
Age, Continuous	63.9 Years STANDARD_DEVIATION 5.8 • n=5 Participants	63.4 Years STANDARD_DEVIATION 6.5 • n=7 Participants	63.7 Years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	40 Participants n=7 Participants	79 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	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Months since last dose in 20050179	32.1 Months STANDARD_DEVIATION 2.5 • n=5 Participants	32.2 Months STANDARD_DEVIATION 2.7 • n=7 Participants	32.1 Months STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=37 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT	-5.5 Percent change Interval -8.3 to -2.8	-1.8 Percent change Interval -4.8 to 1.2

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=37 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT	-1.2 Percent change Interval -2.6 to 0.2	0.3 Percent change Interval -1.2 to 1.7

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=37 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT	-1.0 Percent change Interval -1.7 to -0.3	-0.0 Percent change Interval -0.8 to 0.8

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=37 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT	5.1 Percent change Interval 2.3 to 8.0	5.9 Percent change Interval 2.8 to 9.0

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT	-6.4 Percent change Interval -7.8 to -5.1	-4.6 Percent change Interval -5.9 to -3.3

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT	-1.6 Percent change Interval -2.8 to -0.4	1.0 Percent change Interval -0.2 to 2.2

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT	-1.0 Percent change Interval -1.7 to -0.3	-0.6 Percent change Interval -1.4 to 0.2

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT	2.9 Percent change Interval 1.0 to 4.9	6.8 Percent change Interval 4.9 to 8.8

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA	-2.0 Percent change Interval -3.3 to -0.8	0.0 Percent change Interval -1.2 to 1.2

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA	-3.5 Percent change Interval -4.9 to -2.2	-1.9 Percent change Interval -3.3 to -0.6

SECONDARY outcome

Timeframe: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Population: Participants with observed data.

Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Percent Change of Total Radius BMD From the Parent Study Baseline by DXA	-3.0 Percent change Interval -4.0 to -2.0	-0.9 Percent change Interval -1.9 to 0.1

SECONDARY outcome

Timeframe: Day 1

Population: Participants with observed data.

Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Actual Value of Serum Type I C-telopeptide	0.6 ng/mL Interval 0.5 to 0.6	0.7 ng/mL Interval 0.6 to 0.7

SECONDARY outcome

Timeframe: Day 1

Population: Participants with observed data.

Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).

Outcome measures

Measure	Previous Placebo Treatment Group n=39 Participants Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.	Previous Denosumab Treatment Group n=40 Participants Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Actual Value of Procollagen Type 1 N-terminal Peptide	49.8 µg/L Interval 45.6 to 54.3	58.9 µg/L Interval 54.1 to 64.2

Adverse Events

Previous Placebo Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Previous Denosumab Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER