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

NCT00089674 | Completed Phase 3 Results

• 2 other identifiers: 20040138HALT Prostate Cancer
• Study Type: interventional
• Target: 1,468
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

  Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

  24 months

Secondary Outcomes (9)

• Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24

  24 months

• Total Hip Bone Mineral Density Percent Change From Baseline at Month 24

  24 months

• Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36

  36 months

• Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36

  36 months

• Total Hip Bone Mineral Density Percent Change From Baseline at Month 36

  36 months

Study Arms (2)

AMG 162

EXPERIMENTAL

Drug: AMG 162

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AMG 162 DRUG

60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

AMG 162

Placebo DRUG

60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Other criteria also apply

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Related Publications (6)

• Egerdie RB, Saad F, Smith MR, Tammela TL, Heracek J, Sieber P, Ke C, Leder B, Dansey R, Goessl C. Responder analysis of the effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. Prostate Cancer Prostatic Dis. 2012 Sep;15(3):308-12. doi: 10.1038/pcan.2012.18.

  PMID: 22641239 BACKGROUND

• Lippuner k, Wolff JM, Hadji P, Braun A, Ke C, Steinle T, Eisen C. Risk reduction for vertebral fractures in patients with normal to osteopenic bone mineral density receiving denosumab: A subgroup analysis of the HALT Prostate Cancer Trial. Osteologie 2014;23(2):117-122. [published in German only]

  BACKGROUND

• Smith MR, Egerdie B, Hernandez 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. doi: 10.1056/NEJMoa0809003. Epub 2009 Aug 11.

  PMID: 19671656 BACKGROUND

• 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. doi: 10.1002/jbmr.492.

  PMID: 21898590 BACKGROUND

• 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. doi: 10.1016/j.juro.2009.08.048.

  PMID: 19836774 BACKGROUND

• 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. doi: 10.1177/0022034511407920. Epub 2011 May 9.

  PMID: 21555773 DERIVED

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Denosumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2004
• First Posted: August 11, 2004
• Study Start: August 1, 2004
• Primary Completion: May 16, 2008
• Study Completion: May 11, 2010
• Last Updated: October 17, 2018
• Results First Posted: June 3, 2014

Record last verified: 2018-09