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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 16, 2008

Interventions

  • Drug: AMG 162
    • 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
  • Drug: Placebo
    • 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30

Arms, Groups and Cohorts

  • Experimental: AMG 162
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
    • Time Frame: 24 months
    • Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

Secondary Measures

  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
    • Time Frame: 24 months
    • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
    • Time Frame: 24 months
    • Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36
    • Time Frame: 36 months
    • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36
    • Time Frame: 36 months
    • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 36
    • Time Frame: 36 months
    • Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
  • Number of Participants With Any Fracture Through Month 36
    • Time Frame: 36 months
    • Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.
  • Number of Participants With a New Vertebral Fracture Through Month 36
    • Time Frame: 36 months
    • New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.
  • Time to First Clinical Fracture Through Month 36
    • Time Frame: 36 months
    • A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.
  • Number of Participants With Any Fracture Through Month 24
    • Time Frame: 24 months
    • Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

Participating in This Clinical Trial

Other criteria also apply

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amgen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • MD, Study Director, Amgen

References

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.

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]

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. doi: 10.1056/NEJMoa0809003. Epub 2009 Aug 11.

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.

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.

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