- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00089674
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
September 20, 2018 updated by: Amgen
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
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1468
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Other criteria also apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
|
Experimental: AMG 162
|
60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
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.
|
24 months
|
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.
|
36 months
|
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.
|
36 months
|
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.
|
36 months
|
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.
|
36 months
|
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.
|
36 months
|
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.
|
36 months
|
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.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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, 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2004
Primary Completion (Actual)
May 16, 2008
Study Completion (Actual)
May 11, 2010
Study Registration Dates
First Submitted
August 9, 2004
First Submitted That Met QC Criteria
August 10, 2004
First Posted (Estimate)
August 11, 2004
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
September 20, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20040138
- HALT Prostate Cancer
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedProstate Adenocarcinoma | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on AMG 162
-
Roswell Park Cancer InstituteAmgenCompletedOsteoporosis | Osteopenia | Allogeneic Hematopoietic Stem Cell Transplantation RecipientUnited States
-
Northwestern UniversityNational Cancer Institute (NCI); AmgenTerminatedStage IV Breast Cancer | Estrogen Receptor Positive | HER2/Neu Negative | Progesterone Receptor Positive | Breast Carcinoma Metastatic in the Bone | Circulating Tumor Cell CountUnited States
-
National Cancer Institute (NCI)TerminatedOvarian CarcinomaUnited States, Israel
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Refractory Osteosarcoma | Stage IV Osteosarcoma AJCC v7 | Stage IVA Osteosarcoma AJCC v7 | Stage IVB Osteosarcoma AJCC v7 | Metastatic OsteosarcomaUnited States, Canada, Puerto Rico
-
AmgenCompletedBone Metastases in Men With Hormone-Refractory Prostate Cancer | Bone Metastases in Subjects With Advanced Breast Cancer | Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
-
AmgenCompletedBone Metastases in Men With Hormone-Refractory Prostate Cancer | Bone Metastases in Subjects With Advanced Breast Cancer | Bone Metastases in Subjects With Advanced Cancer or Multiple MyelomaUnited Kingdom, Czech Republic
-
M.D. Anderson Cancer CenterAmgenTerminated
-
AmgenCompleted
-
AmgenCompletedBreast Cancer | Osteopenia | Low Bone Mineral Density