AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Amgen.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00089674

First received: August 9, 2004

Last updated: December 3, 2009

Last verified: December 2009

History of Changes

Purpose

This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: AMG 162 Drug: Placebo	Phase 3

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: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

The primary endpoint is the percentage change from baseline in lumbar spine BMD to month 24. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change of femoral neck BMD, and total hip BMD from baseline to month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Percent change of lumbar spine BMD, femoral neck BMD and total hip BMD from baseline to month 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Subject incidence of any fracture and subject incidence of new vertebral fracture over the 36-month evaluation period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Time to first clinical fracture over the 36-month evaluation period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Subject incidence of any fracture during the 24-month evaluation period [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Adverse event incidence by system organ class and preferred term [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Laboratory values (including changes in chemistry, hematology, and immunological laboratory parameters) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Changes in vital signs, weight and height at each visit [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Subject incidence of anti-AMG 162 antibodies [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
AMG 162 serum levels at day 1, and months 1, 3, 6, 12, 15, 18, 24, 30 and 36 (PK) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Enrollment:	1468
Study Start Date:	August 2004
Estimated Study Completion Date:	May 2010
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AMG 162	Drug: AMG 162 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
Placebo Comparator: Placebo	Drug: Placebo 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Other criteria also apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089674

Show 138 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Smith MR, Egerdie B, Hernández Toriz N, Feldman R, Tammela TL, Saad F, Heracek J, Szwedowski M, Ke C, Kupic A, Leder BZ, Goessl C; Denosumab HALT Prostate Cancer Study Group. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med. 2009 Aug 20;361(8):745-55. Epub 2009 Aug 11.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Smith MR, Saad F, Egerdie B, Sieber P, Tammela TLj, Leder BZ, Ke C, Goessl C. Denosumab and changes in bone turnover markers during androgen deprivation therapy for prostate cancer. J Bone Miner Res. 2011 Dec;26(12):2827-33.

Kuchler U, Luvizuto ER, Tangl S, Watzek G, Gruber R. Short-term teriparatide delivery and osseointegration: a clinical feasibility study. J Dent Res. 2011 Aug;90(8):1001-6. Epub 2011 May 9.

Smith MR, Saad F, Egerdie B, Szwedowski M, Tammela TL, Ke C, Leder BZ, Goessl C. Effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. J Urol. 2009 Dec;182(6):2670-5.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00089674 History of Changes
Other Study ID Numbers:	20040138, HALT
Study First Received:	August 9, 2004
Last Updated:	December 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Prostate Cancer
Bone Loss with Prostate Cancer
Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC).

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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