Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Postmenopausal Osteoporosis
Interventions:	Drug: AMG 162 Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Denosumab 60 mg Q6M	No text entered.
Placebo	No text entered.

Participant Flow: Overall Study

	Denosumab 60 mg Q6M	Placebo
STARTED	166	166
COMPLETED	142	144
NOT COMPLETED	24	22
Adverse Event	1	2
Withdrawal by Subject	10	15
Ineligibility determined	2	0
Lost to Follow-up	7	5
Noncompliance	2	0
Other	2	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Denosumab 60 mg Q6M	No text entered.
Placebo	No text entered.

Baseline Measures

	Denosumab 60 mg Q6M	Placebo	Total
Number of Participants [units: participants]	166	166	332
Age [units: Years] Mean ± Standard Deviation	59.8 ± 7.4	58.9 ± 7.5	59.4 ± 7.5
Gender [units: Participants]
Female	166	166	332
Male	0	0	0

Outcome Measures

Show All Outcome Measures

1. Primary:

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ]

Show Outcome Measure 1

2. Secondary:

Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ]

Show Outcome Measure 2

3. Secondary:

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 Months ]

Show Outcome Measure 3

4. Secondary:

Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]

Show Outcome Measure 4

5. Secondary:

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]

Show Outcome Measure 5

6. Secondary:

Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]

Show Outcome Measure 6

7. Secondary:

Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]

Show Outcome Measure 7

8. Secondary:

Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]

Show Outcome Measure 8

9. Secondary:

Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 [ Time Frame: 24 months ]

Show Outcome Measure 9

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

Publications of Results:

Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. Epub 2008 Apr 1.

Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. Epub 2009 Apr 2.

Publications automatically indexed to this study:

Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. Epub 2011 Feb 2.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00091793 History of Changes
Other Study ID Numbers:	20040132
Study First Received:	September 17, 2004
Results First Received:	December 22, 2009
Last Updated:	December 22, 2010
Health Authority:	United States: Food and Drug Administration