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Prostate CancerPhase 3NCT00089674

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

A Phase 3 study testing AMG 162 in people with Prostate Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
AMG 162
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,468 participants
Where
No sites listed yet
Study dates
1 Aug 2004to 11 May 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Other criteria also apply

About this study

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

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
Being tested
AMG 162, Placebo
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).
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 162Drug

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

  • PlaceboDrug

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

Study groups in NCT00089674
Study groupRoleWhat they receive
AMG 162ExperimentalNot described
Receives: Drug: AMG 162
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (9)

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

    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

    Measured: 24 months

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

    Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

    Measured: 24 months

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

    Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

    Measured: 36 months

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

    Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

    Measured: 36 months

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

    Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

    Measured: 36 months

  6. Number of Participants With Any Fracture Through Month 36

    Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

    Measured: 36 months

  7. Number of Participants With a New Vertebral Fracture Through Month 36

    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.

    Measured: 36 months

  8. Time to First Clinical Fracture Through Month 36

    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.

    Measured: 36 months

  9. Number of Participants With Any Fracture Through Month 24

    Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2004 (estimated)
  2. Study start1 Aug 2004
  3. Primary completion16 May 2008
  4. Study completion11 May 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,468 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089674
Sponsor's protocol ID
20040138
Other IDs
HALT Prostate Cancer
Status last verified
Sep 2018
First submitted
9 Aug 2004
Last updated
17 Oct 2018

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.

    PubMed 22641239

  • 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.

    PubMed 19671656

  • 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.

    PubMed 21898590

  • 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.

    PubMed 19836774

  • 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.

    PubMed 21555773

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AMG 162 in people with Prostate Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00089674, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

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