CancerPhase 3NCT00925600

Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

A Phase 3 study testing Denosumab in people with Cancer and Cataract, run by Amgen at 172 sites in 18 countries.

Completed

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

Trial summary

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy. Read more about this study

Who is it for?: Ages 30 to 120 years, men only
Conditions the study is for: Cancer, Cataract, Low Bone Mineral Density
What is being tested?: Denosumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 769 participants
Where: 172 sitesin 18 countries
Study dates: 30 Nov 2009to 12 May 2016
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 30 to 120 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for at least 12 months
Adequate visual accuracy allowing eye testing
Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age
Signed informed consent

Who cannot join

Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss
Diagnosis of osteoporosis

Trial locations and contacts

172 sites in 18 countries.

Country

City, postcode or hospital

172 sites in 18 countries

United States52 sites

Research Site
Albany, New York, 12208
Research Site
Anaheim, California, 92801
Research Site
Annapolis, Maryland, 21401
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Austin, Texas, 78759
Research Site
Bala-Cynwyd, Pennsylvania, 19004
Research Site
Baltimore, Maryland, 21201
Research Site
Berlin, New Jersey, 08009
Research Site
Brick, New Jersey, 08724
Research Site
Cincinnati, Ohio, 45212
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Coeur d'Alene, Idaho, 83814
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Dallas, Texas, 75231
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Denver, Colorado, 80204
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Denver, Colorado, 80211
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Englewood, Colorado, 80113
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Englewood, New Jersey, 07631
Research Site
Garden City, New York, 11530
Research Site
Gastonia, North Carolina, 28054
Research Site
Grand Rapids, Michigan, 49546
Research Site
Greenbelt, Maryland, 20770
Research Site
Greenville, North Carolina, 27834
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Greenwood, Indiana, 46143
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Kansas City, Kansas, 66160
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Kingston, New York, 12401
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Knoxville, Tennessee, 37920
Research Site
Laguna Hills, California, 92653
Research Site
Lancaster, Pennsylvania, 17604
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Lawrenceville, New Jersey, 08648
Research Site
Middlebury, Connecticut, 06762
Research Site
Missoula, Montana, 59808
Research Site
Mount Laurel, New Jersey, 08054
Research Site
Murrieta, California, 92562
Research Site
Myrtle Beach, South Carolina, 29572
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New Britain, Connecticut, 06052
Research Site
New York, New York, 10021
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Omaha, Nebraska, 68105-1850
Research Site
Omaha, Nebraska, 68130
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Poughkeepsie, New York, 12601
Research Site
Richmond, Virginia, 23235
Research Site
Salem, Virginia, 24153
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San Antonio, Texas, 78229
Research Site
San Diego, California, 92103
Research Site
San Diego, California, 92120
Research Site
San Diego, California, 92123
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San Luis Obispo, California, 93405
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Sartell, Minnesota, 56377
Research Site
Shreveport, Louisiana, 71106
Research Site
St Louis, Missouri, 63110
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Syracuse, New York, 13210
Research Site
Temple, Texas, 76508
Research Site
Trinity, Florida, 34655
Research Site
West Des Moines, Iowa, 50266

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Canada22 sites

Research Site
Barrie, Ontario, L4M 7G1
Research Site
Brampton, Ontario, L6T 4S5
Research Site
Brantford, Ontario, N3S 6T6
Research Site
Burlington, Ontario, L7N 3V2
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Guelph, Ontario, N1H 5J1
Research Site
Halifax, Nova Scotia, B3H 2Y9
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Kelowna, British Columbia, V1W 4V5
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Kitchener, Ontario, N2N 2B9
Research Site
Laval, Quebec, H7G 2E6
Research Site
London, Ontario, N6A 4G5
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Montreal, Quebec, H2L 4M1
Research Site
Newmarket, Ontario, L3X 1W1
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North Bay, Ontario, P1B 7K8
Research Site
North York, Ontario, M3B 3S6
Research Site
Oakville, Ontario, L6H 3P1
Research Site
Scarborough Village, Ontario, M1P 2T7
Research Site
Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2M9
Research Site
Toronto, Ontario, M6A 3B5
Research Site
Vancouver, British Columbia, V5Z 1M9
Research Site
Victoria, British Columbia, V8T 5G1
Research Site
Victoria, British Columbia, V8V 3N1

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Poland16 sites

Research Site
Gdansk, 80-180
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Gdansk, 80-952
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Gdynia, 81-366
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Gdynia, 81-423
Research Site
Katowice, 40-857
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Mysłowice, 41-400
Research Site
Opole, 45-086
Research Site
Poznan, 61-866
Research Site
Rzeszów, 35-021
Research Site
Siedlce, 08-110
Research Site
Słupsk, 76-200
Research Site
Szczecin, 70-111
Research Site
Warsaw, 00-631
Research Site
Warsaw, 02-005
Research Site
Warsaw, 02-781
Research Site
Wroclaw, 50-044

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Czechia13 sites

Research Site
Benešov, 256 01
Research Site
Brno, 612 00
Research Site
Hradec Králové, 500 05
Research Site
Jindřichův Hradec, 377 01
Research Site
Kroměříž, 767 55
Research Site
Nový Jičín, 741 01
Research Site
Olomouc, 775 20
Research Site
Pilsen, 305 99
Research Site
Prague, 120 00
Research Site
Prague, 140 00
Research Site
Prague, 160 00
Research Site
Ústí nad Labem, 401 13
Research Site
Zlín, 760 01

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Greece9 sites

Research Site
Alexandroupoli, 68100
Research Site
Athens, 11522
Research Site
Athens, 11526
Research Site
Athens, 11527
Research Site
Heraklion, 71110
Research Site
Larissa, 41110
Research Site
Pátrai, 26504
Research Site
Thessaloniki, 54622
Research Site
Thessaloniki, 56429

Other trials in Greece

Hungary8 sites

Research Site
Baja, 6500
Research Site
Budapest, 1036
Research Site
Budapest, 1082
Research Site
Budapest, 1204
Research Site
Győr, 9023
Research Site
Miskolc, 3526
Research Site
Nyíregyháza, 4400
Research Site
Szeged, 6722

Other trials in Hungary

India7 sites

Research Site
Ahmedabad, Gujarat, 380 009
Research Site
Bangalore, Karnataka, 560 027
Research Site
Chhatrapati Sambhajinagar, Maharashtra, 431 005
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Kolkata, West Bengal, 700 027
Research Site
Ludhiana, Punjab, 141 008
Research Site
Madurai, Tamil Nadu, 625 107
Research Site
Nashik, Maharashtra, 422 004

Other trials in India

Slovakia7 sites

Research Site
Bratislava, 851 05
Research Site
Košice, 040 01
Research Site
Košice, 040 11
Research Site
Košice, 040 23
Research Site
Martin, 036 59
Research Site
Nitra, 949 01
Research Site
Trenčín, 911 01

Other trials in Slovakia

Russia6 sites

Research Site
Ivanovo, 153013
Research Site
Moscow, 105425
Research Site
Moscow, 115478
Research Site
Moscow, 125284
Research Site
Nizhny Novgorod, 603126
Research Site
Rostov-on-Don, 344022

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Ukraine6 sites

Research Site
Chernivtsi, 58002
Research Site
Dnipropetrovsk, 49005
Research Site
Kharkiv, 61037
Research Site
Kyiv, 02125
Research Site
Uzhhorod, 88000
Research Site
Zaporizhzhya, 69600

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South Africa5 sites

Research Site
George, 6530
Research Site
Kempton Park, 1619
Research Site
Paarl, Western Cape, 7646
Research Site
Port Elizabeth, 6001
Research Site
Tygerberg, 7505

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Australia4 sites

Research Site
Bentleigh East, Victoria, 3165
Research Site
Herston, Queensland, 4029
Research Site
Ringwood East, Victoria, 3135
Research Site
Wahroonga, New South Wales, 2076

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New Zealand4 sites

Research Site
Christchurch, 8013
Research Site
Takapuna, North Shore City, 0622
Research Site
Tauranga, 3112
Research Site
Whangarei, 0112

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Bulgaria3 sites

Research Site
Pleven, 5800
Research Site
Plovdiv, 4004
Research Site
Sofia, 1784

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Latvia3 sites

Research Site
Jelgava, 3001
Research Site
Riga, 1002
Research Site
Riga, 1079

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Slovenia3 sites

Research Site
Celje, 3000
Research Site
Ljubljana, 1525
Research Site
Slovenj Gradec, 2380

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France2 sites

Research Site
Lyon Cédex 3, 69437
Research Site
Paris, 75248

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Mexico2 sites

Research Site
Distrito Federal, 01120
Research Site
Distrito Federal, 11950

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About this study

Official title: A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy

Conditions: Cancer, Cataract, Low Bone Mineral Density, Osteopenia, Osteoporosis, Prostate Cancer
Being tested: Denosumab, Placebo
Keywords: Lens Opacification, Bone Loss, Androgen Deprivation Therapy, Non-metastatic prostate cancer
Medical subject headings: Neoplasms, Cataract, Bone Diseases, Metabolic, Osteoporosis, Prostatic Neoplasms

What participants receive

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

DenosumabBiological
Also called Prolia®
Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
PlaceboBiological
Prefilled syringe for subcutaneous (SC) injection

Study groups in NCT00925600
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6. Receives: Biological: Placebo
Denosumab	Experimental	Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6. Receives: Biological: Denosumab

What is being measured

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

Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.
Measured: 12 months

Timeline

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

30 Nov 200912 May 2016

First posted22 Jun 2009 (estimated)
Study start30 Nov 2009
Primary completion12 May 2016
Study completion12 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 769 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00925600
Sponsor's protocol ID: 20080560
Other IDs: 2009-012076-26, 2009
Status last verified: Apr 2017
First submitted: 18 Jun 2009
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy
ClinicalTrials.gov ID: NCT00925600
Acronym / sponsor ID: 20080560
Conditions: Cancer, Cataract, Low Bone Mineral Density, Osteopenia, Osteoporosis, Prostate Cancer
Keywords: Lens Opacification, Bone Loss, Androgen Deprivation Therapy, Non-metastatic prostate cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 769 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 30 Nov 2009 (actual)
Primary completion: 12 May 2016 (actual)
Study completion: 12 May 2016 (actual)
First posted: 22 Jun 2009 (estimated)
Results: Posted 30 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Biological: PlaceboParticipants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
Denosumab	Experimental	Biological: DenosumabParticipants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.

Who may qualify

Ages: 30 to 120 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for at least 12 months
Adequate visual accuracy allowing eye testing
Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age
Signed informed consent

Key exclusion criteria (2 listed)

Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss
Diagnosis of osteoporosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DenosumabAlso: Prolia®Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg	Biological	Denosumab
PlaceboPrefilled syringe for subcutaneous (SC) injection	Biological	Placebo

Primary outcome

Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
Time frame: 12 months
The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.

Results and safety

Results posted to the registry on 30 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	386	354
Denosumab	383	355

Primary outcome: Percentage of Participants With Lens Opacification Event Development or Progression by Month 12

Time frame: 12 months. Number. Unit: percentage of participants

Measure	Placebo n = 374	Denosumab n = 379
Value	33.2	33.5

Placebo vs Denosumab: Risk Difference (RD): 0.4 (95% CI -6.3 to 7.2), p = 0.0026, Mantel Haenszel

Population analysed: The lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site. Three participants randomized to placebo who received ≥ 1 dose of denosumab in error are analyzed in the denosumab group.

Adverse events

Time frame: 12 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	52 of 380 (13.7%)	107 of 380 (28.2%)	Not reported
Denosumab	42 of 385 (10.9%)	121 of 385 (31.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

172 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Denosumab in people with Cancer and Cataract, run by Amgen at 172 sites in 18 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, Canada, Poland, Czechia, Greece and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 30 May 2017). 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?

Percentage of Participants With Lens Opacification Event Development or Progression by Month 12 (time frame: 12 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 NCT00925600.

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 30 May 2017.