A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00890981

First received: April 23, 2009

Last updated: June 30, 2011

Last verified: June 2011

History of Changes

Results First Received: June 30, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Conditions:	Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis
Intervention:	Procedure: HR-pQCT, DXA and BTM measurements

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject enrolled on 14-JUL-2009. The last subject enrolled on 12-MAY-2010

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Previous Placebo Treatment Group	Subjects who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Previous Denosumab 60 mg Q6M Treatment Group	Subjects who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.

Participant Flow: Overall Study

	Previous Placebo Treatment Group	Previous Denosumab 60 mg Q6M Treatment Group
STARTED	39	40
COMPLETED	39	40
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Previous Placebo Treatment Group	Subjects who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Previous Denosumab 60 mg Q6M Treatment Group	Subjects who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
Total	Total of all reporting groups

Baseline Measures

	Previous Placebo Treatment Group	Previous Denosumab 60 mg Q6M Treatment Group	Total
Number of Participants [units: participants]	39	40	79
Age [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	12	21	33
>=65 years	17	19	36
Age [units: Years] Mean ± Standard Deviation	63.9 ± 5.8	63.4 ± 6.5	63.7 ± 6.1
Gender [units: Participants]
Female	39	40	79
Male	0	0	0
Race/Ethnicity, Customized [units: Participants]
White or Caucasian	39	40	79
Months since last SC dose of 20050179 [units: Months] Mean ± Standard Deviation	32.1 ± 2.5	32.2 ± 2.7	32.1 ± 2.6

Outcome Measures

Show All Outcome Measures

1. Primary:

Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ]

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
Measure Description	Percent change from the 20050179 baseline in cortical thickness at the distal radius as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179
Time Frame	Day 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects with observed data and baseline

Reporting Groups

	Description
Previous Placebo Treatment Group	Subjects who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
Previous Denosumab 60 mg Q6M Treatment Group	Subjects who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.

Measured Values

	Previous Placebo Treatment Group	Previous Denosumab 60 mg Q6M Treatment Group
Number of Participants Analyzed [units: participants]	39	37
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT [units: Percent] Least Squares Mean ( 95% Confidence Interval )	-5.5 ( -8.3 to -2.8 )	-1.8 ( -4.8 to 1.2 )

Statistical Analysis 1 for Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0766
Mean Difference (Final Values) ^[4]	3.7
95% Confidence Interval	( -0.4 to 7.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

2. Secondary:

Percent Change From the Parent Study Baseline in Total BMD at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ]

Show Outcome Measure 2

3. Secondary:

Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ]

Show Outcome Measure 3

4. Secondary:

Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ]

Show Outcome Measure 4

5. Secondary:

Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ]

Show Outcome Measure 5

6. Secondary:

Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ]

Show Outcome Measure 6

7. Secondary:

Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ]

Show Outcome Measure 7

8. Secondary:

Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ]

Show Outcome Measure 8

9. Secondary:

Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA [ Time Frame: Day 1 ]

Show Outcome Measure 9

10. Secondary:

Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA [ Time Frame: Day 1 ]

Show Outcome Measure 10

11. Secondary:

Percent Change of Total Radius BMD From the Parent Study Baseline by DXA [ Time Frame: Day 1 ]

Show Outcome Measure 11

12. Secondary:

Actual Value of Serum Type I C-telopeptide [ Time Frame: Day 1 ]

Show Outcome Measure 12

13. Secondary:

Actual Value of Procollagen Type 1 N-terminal Peptide [ Time Frame: Day 1 ]

Show Outcome Measure 13

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00890981 History of Changes
Other Study ID Numbers:	20080747
Study First Received:	April 23, 2009
Results First Received:	June 30, 2011
Last Updated:	June 30, 2011
Health Authority:	Argentina: Ministry of Health Canada: Health Canada United States: Food and Drug Administration Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)

To Top