Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00043186

First received: August 6, 2002

Last updated: June 25, 2010

Last verified: June 2010

History of Changes

Results First Received: December 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Low Bone Mineral Density
Interventions:	Drug: Placebo Drug: Denosumab Drug: Active comparator

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
First Subject Enrolled: 11-May-2002 Last Subject Enrolled: 30-Apr-2003

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 100 mg Q6M	No text entered.
Placebo	No text entered.
Denosumab 6 mg Q3M	No text entered.
Denosumab 14 mg Q3M	No text entered.
Denosumab 30 mg Q3M	No text entered.
Denosumab 14 mg Q6M	No text entered.
Denosumab 60 mg Q6M	No text entered.
Denosumab 210 mg Q6M	No text entered.
Alendronate 70 mg QW	No text entered.

Participant Flow: Overall Study

	Denosumab 100 mg Q6M	Placebo	Denosumab 6 mg Q3M	Denosumab 14 mg Q3M	Denosumab 30 mg Q3M	Denosumab 14 mg Q6M	Denosumab 60 mg Q6M	Denosumab 210 mg Q6M	Alendronate 70 mg QW
STARTED	42	46	44	44	41	54	47	47	47
COMPLETED	25	29	29	24	19	36	39	31	30
NOT COMPLETED	17	17	15	20	22	18	8	16	17
Physician Decision	0	0	0	3	0	1	0	1	1
Adverse Event	2	2	2	2	3	2	1	1	3
Withdrawal by Subject	12	11	8	11	13	14	6	9	10
Death	2	0	0	1	0	0	0	0	0
Disease progression	0	1	0	0	3	0	0	4	0
Ineligibility determined	0	0	0	0	0	0	0	0	1
Lost to Follow-up	1	3	5	1	1	1	1	1	2
Noncompliance	0	0	0	1	1	0	0	0	0
Other	0	0	0	1	1	0	0	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Denosumab 100 mg Q6M	No text entered.
Placebo	No text entered.
Denosumab 6 mg Q3M	No text entered.
Denosumab 14 mg Q3M	No text entered.
Denosumab 30 mg Q3M	No text entered.
Denosumab 14 mg Q6M	No text entered.
Denosumab 60 mg Q6M	No text entered.
Denosumab 210 mg Q6M	No text entered.
Alendronate 70 mg QW	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Denosumab 100 mg Q6M	Placebo	Denosumab 6 mg Q3M	Denosumab 14 mg Q3M	Denosumab 30 mg Q3M	Denosumab 14 mg Q6M	Denosumab 60 mg Q6M	Denosumab 210 mg Q6M	Alendronate 70 mg QW	Total
Number of Participants [units: participants]	42	46	44	44	41	54	47	47	47	412
Age [units: Years] Mean ± Standard Deviation	64.9 ± 8.2	63.7 ± 9.1	62.8 ± 8.6	62.3 ± 6	61.2 ± 8.5	61.4 ± 8.1	63.1 ± 8.1	60.5 ± 7.8	62.8 ± 8.2	62.5 ± 8.1
Gender [units: Participants]
Female	42	46	44	44	41	54	47	47	47	412
Male	0	0	0	0	0	0	0	0	0	0
Race/Ethnicity, Customized [units: Participants]
White or Caucasian	37	37	33	42	36	49	39	42	40	355
Black or African American	3	0	1	1	2	1	1	0	3	12
Hispanic or Latino	2	8	8	1	3	3	5	5	4	39
Asian	0	1	1	0	0	0	2	0	0	4
Japanese	0	0	0	0	0	1	0	0	0	1
American Indian or Alaska Native	0	0	1	0	0	0	0	0	0	1

Outcome Measures

Show All Outcome Measures

1. Primary:

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms [ Time Frame: 12 months ]

Show Outcome Measure 1

2. Secondary:

Serum CTX Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]

Show Outcome Measure 2

3. Secondary:

Urine NTX/Creatinine Percent Change From Baseline at Month 12 [ Time Frame: 12 months ]

Show Outcome Measure 3

4. Secondary:

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm [ Time Frame: 12 months ]

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 [ Time Frame: From Baseline to 36 months ]

Show Outcome Measure 6

7. Secondary:

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42 [ Time Frame: From Baseline to 42 months ]

Show Outcome Measure 7

8. Secondary:

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48 [ Time Frame: From Baseline to 48 months ]

Show Outcome Measure 8

9. Secondary:

Serum CTX Percent Change From Baseline at Month 24 [ Time Frame: From Baseline to 24 months ]

Show Outcome Measure 9

10. Secondary:

Serum CTX Percent Change From Baseline at Month 36 [ Time Frame: From Baseline to 36 months ]

Show Outcome Measure 10

11. Secondary:

Serum CTX Percent Change From Baseline at Month 42 [ Time Frame: From Baseline to 42 months ]

Show Outcome Measure 11

12. Secondary:

Serum CTX Percent Change From Baseline at Month 48 [ Time Frame: From Baseline to 48 months ]

Show Outcome Measure 12

13. Secondary:

Urine NTX/Creatinine Percent Change From Baseline at Month 24 [ Time Frame: From Baseline to 24 months ]

Show Outcome Measure 13

14. Secondary:

Urine NTX/Creatinine Percent Change From Baseline at Month 36 [ Time Frame: From Baseline to 36 months ]

Show Outcome Measure 14

15. Secondary:

Urine NTX/Creatinine Percent Change From Baseline at Month 42 [ Time Frame: From Baseline to 42 months ]

Show Outcome Measure 15

16. Secondary:

Urine NTX/Creatinine Percent Change From Baseline at Month 48 [ Time Frame: From Baseline to 48 months ]

Show Outcome Measure 16

17. Secondary:

Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: From Baseline to 12 months ]

Show Outcome Measure 17

18. Secondary:

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

Show Outcome Measure 18

19. Secondary:

Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 [ Time Frame: From Baseline to 36 months ]

Show Outcome Measure 19

20. Secondary:

Total Hip Bone Mineral Density Percent Change From Baseline at Month 42 [ Time Frame: From Baseline to 42 months ]

Show Outcome Measure 20

21. Secondary:

Total Hip Bone Mineral Density Percent Change From Baseline at Month 48 [ Time Frame: From Baseline to 48 months ]

Show Outcome Measure 21

22. Secondary:

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: From Baseline to 12 months ]

Show Outcome Measure 22

23. Secondary:

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

Show Outcome Measure 23

24. Secondary:

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36 [ Time Frame: From Baseline to 36 months ]

Show Outcome Measure 24

25. Secondary:

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42 [ Time Frame: From Baseline to 42 months ]

Show Outcome Measure 25

26. Secondary:

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48 [ Time Frame: From Baseline to 48 months ]

Show Outcome Measure 26

27. Secondary:

Total Body Bone Mineral Density Percent Change From Baseline at Month 12 [ Time Frame: From Baseline to 12 months ]

Show Outcome Measure 27

28. Secondary:

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

Show Outcome Measure 28

29. Secondary:

Total Body Bone Mineral Density Percent Change From Baseline at Month 36 [ Time Frame: From Baseline to 36 months ]

Show Outcome Measure 29

30. Secondary:

Total Body Bone Mineral Density Percent Change From Baseline at Month 42 [ Time Frame: From Baseline to 42 months ]

Show Outcome Measure 30

31. Secondary:

Total Body Bone Mineral Density Percent Change From Baseline at Month 48 [ Time Frame: From Baseline to 48 months ]

Show Outcome Measure 31

32. Secondary:

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12 [ Time Frame: From Baseline to 12 months ]

Show Outcome Measure 32

33. Secondary:

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24 [ Time Frame: From Baseline to 24 months ]

Show Outcome Measure 33

34. Secondary:

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36 [ Time Frame: From Baseline to 36 months ]

Show Outcome Measure 34

35. Secondary:

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42 [ Time Frame: From Baseline to 42 months ]

Show Outcome Measure 35

36. Secondary:

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48 [ Time Frame: From Baseline to 48 months ]

Show Outcome Measure 36

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:

McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, Peacock M, Miller PD, Lederman SN, Chesnut CH, Lain D, Kivitz AJ, Holloway DL, Zhang C, Peterson MC, Bekker PJ; AMG 162 Bone Loss Study Group. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med. 2006 Feb 23;354(8):821-31.

Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J, For The Amg 162 Bone Loss Study Group. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: A randomized blinded phase 2 clinical trial. Bone. 2008 Aug;43(2):222-229. Epub 2008 Apr 26.

Lewiecki EM, Miller PD, McClung MR, Cohen SB, Bolognese MA, Liu Y, Wang A, Siddhanti S, Fitzpatrick LA; AMG 162 Bone Loss Study Group. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD. J Bone Miner Res. 2007 Dec;22(12):1832-41.

Beck TJ, Lewiecki EM, Miller PD, Felsenberg D, Liu Y, Ding B, Libanati C. Effects of denosumab on the geometry of the proximal femur in postmenopausal women in comparison with alendronate. J Clin Densitom. 2008 Jul-Sep;11(3):351-9. Epub 2008 May 20.

Peterson MC, Riggs MM. A physiologically based mathematical model of integrated calcium homeostasis and bone remodeling. Bone. 2010 Jan;46(1):49-63. Epub 2009 Sep 2.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00043186 History of Changes
Other Study ID Numbers:	20010223
Study First Received:	August 6, 2002
Results First Received:	December 22, 2009
Last Updated:	June 25, 2010
Health Authority:	United States: Food and Drug Administration

To Top