AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00089674 |
Recruitment Status :
Completed
First Posted : August 11, 2004
Results First Posted : June 3, 2014
Last Update Posted : October 17, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: AMG 162 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1468 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Actual Study Start Date : | August 1, 2004 |
Actual Primary Completion Date : | May 16, 2008 |
Actual Study Completion Date : | May 11, 2010 |

Arm | Intervention/treatment |
---|---|
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 |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089674
Study Director: | MD | Amgen |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00089674 History of Changes |
Other Study ID Numbers: |
20040138 HALT Prostate Cancer |
First Posted: | August 11, 2004 Key Record Dates |
Results First Posted: | June 3, 2014 |
Last Update Posted: | October 17, 2018 |
Last Verified: | September 2018 |
Prostate Cancer Bone Loss with Prostate Cancer Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC). |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Denosumab Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents |