Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

A Phase 2 study testing Denosumab and IV Bisphosphonates in people with Breast Cancer and Metastases, run by Amgen.

Completed

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

Trial summary

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
What is being tested?: Denosumab and IV Bisphosphonates
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: No sites listed yet
Study dates: Sep 2004to Oct 2006
Phase: Phase 2
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
Women only
No healthy volunteers
Adult, Older adult

Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma

At least one bone metastasis

About this study

Official title: A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Conditions: Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
Being tested: Denosumab, IV Bisphosphonates
Keywords: Breast Cancer, Cancer
Medical subject headings: Breast Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

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

DenosumabBiological
Also called AMG 162
Denosumab administered by subcutaneous injection
IV BisphosphonatesDrug
Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid

Study groups in NCT00091832
Study group	Role	What they receive
Denosumab 60 mg every 12 weeks	Experimental	Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. Receives: Biological: Denosumab
Denosumab 120 mg every 4 weeks	Experimental	Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. Receives: Biological: Denosumab
Denosumab 180 mg every 4 weeks	Experimental	Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. Receives: Biological: Denosumab
IV bisphosphonates every 4 weeks	Active comparator	Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks. Receives: Drug: IV Bisphosphonates
Denosumab 180 mg every 12 weeks	Experimental	Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. Receives: Biological: Denosumab
Denosumab 30 mg every 4 weeks	Experimental	Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. Receives: Biological: Denosumab

What is being measured

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

Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.
Measured: Baseline and Week 13

Secondary outcomes (17)

Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)
Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 25
Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13
The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.
Measured: Baseline and Week 13
Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25
The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.
Measured: Baseline and Week 25
Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline
Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.
Measured: Baseline to Week 57
Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)
Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and week 13
Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)
Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 25
Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)
Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 13
Percent Change From Baseline to Week 25 in P1NP
Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.
Measured: Baseline and Week 25
Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 13
Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 25
Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)
Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 13
Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)
Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 25
Percent Change From Baseline to Week 13 in Osteocalcin
Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.
Measured: Baseline and Week 13
Percent Change From Baseline to Week 25 in Osteocalcin
Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.
Measured: Baseline and Week 25
Time to First Skeletal Related Event
Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).
Measured: Day 1 to Week 25
Number of Participants With Skeletal Related Events
Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).
Measured: From Day 1 to Week 25
Number of Participants With Hypercalcemia
Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.
Measured: Day 1 to Week 57

Timeline

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

Sep 2004Oct 2006

First posted21 Sep 2004 (estimated)
Study startSep 2004
Primary completionNov 2005
Study completionOct 2006

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Breast 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 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00091832
Sponsor's protocol ID: 20040113
Status last verified: Dec 2013
First submitted: 17 Sep 2004
Last updated: 28 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Campbell-Baird C, Lipton A, Sarkenshik M, Ma H, Jun S.Incidence of Acute Phase Events Following Denosumab or Intravenous Bisphosphonates: Results From a Randomized, Controlled Phase 2 Study in Patients With Breast Cancer and Bone Metastases.Journal-001752;2010;7:85-89.
Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman RE, Paterson AH, Gao GM, Kinsey AC, Peterson MC, Jun S. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res. 2008 Oct 15;14(20):6690-6. doi: 10.1158/1078-0432.CCR-07-5234.
PubMed 18927312
Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman R, Paterson AH, Peterson MC, Fan M, Kinsey A, Jun S. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol. 2007 Oct 1;25(28):4431-7. doi: 10.1200/JCO.2007.11.8604. Epub 2007 Sep 4.
PubMed 17785705
Peterson M, Rodriquez R., Gurrola E., Sohn W, Jun S (others??).Population pharmacokinetics and pharmacodynamics of denosumab in breast cancer patients with bone metastases.Journal-000709;

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?

Official record

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
ClinicalTrials.gov ID: NCT00091832
Acronym / sponsor ID: 20040113
Conditions: Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
Keywords: Breast Cancer, Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 255 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Sep 2004
Primary completion: Nov 2005 (actual)
Study completion: Oct 2006 (actual)
First posted: 21 Sep 2004 (estimated)
Results: Posted 7 Jan 2011

Clinical summary

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

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Denosumab 60 mg every 12 weeks	Experimental	Biological: DenosumabDenosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Denosumab 120 mg every 4 weeks	Experimental	Biological: DenosumabDenosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Denosumab 180 mg every 4 weeks	Experimental	Biological: DenosumabDenosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
IV bisphosphonates every 4 weeks	Active comparator	Drug: IV BisphosphonatesOpen label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.
Denosumab 180 mg every 12 weeks	Experimental	Biological: DenosumabDenosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.
Denosumab 30 mg every 4 weeks	Experimental	Biological: DenosumabDenosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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: AMG 162Denosumab administered by subcutaneous injection	Biological	Denosumab 120 mg every 4 weeks, Denosumab 180 mg every 12 weeks, Denosumab 180 mg every 4 weeks, Denosumab 30 mg every 4 weeks, Denosumab 60 mg every 12 weeks
IV BisphosphonatesCommercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid	Drug	IV bisphosphonates every 4 weeks

Primary outcome

Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)
Time frame: Baseline and Week 13
Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.

17 secondary outcomes

Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)
Time frame: Baseline and Week 25
Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13
Time frame: Baseline and Week 13
Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25
Time frame: Baseline and Week 25
Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline
Time frame: Baseline to Week 57
Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)
Time frame: Baseline and week 13
Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)
Time frame: Baseline and Week 25
Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)
Time frame: Baseline and Week 13
Percent Change From Baseline to Week 25 in P1NP
Time frame: Baseline and Week 25
Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Time frame: Baseline and Week 13
Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Time frame: Baseline and Week 25
Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)
Time frame: Baseline and Week 13
Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)
Time frame: Baseline and Week 25
Percent Change From Baseline to Week 13 in Osteocalcin
Time frame: Baseline and Week 13
Percent Change From Baseline to Week 25 in Osteocalcin
Time frame: Baseline and Week 25
Time to First Skeletal Related Event
Time frame: Day 1 to Week 25
Number of Participants With Skeletal Related Events
Time frame: From Day 1 to Week 25
Number of Participants With Hypercalcemia
Time frame: Day 1 to Week 57

Results and safety

Results posted to the registry on 7 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bisphosphonate IV Q4W	43	29
Denosumab 30 mg Q4W	42	31
Denosumab 120 mg Q4W	42	30
Denosumab 180 mg Q4W	43	29
Denosumab 60 mg Q12W	42	27
Denosumab 180 mg Q12W	43	32

Primary outcome: Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)

Time frame: Baseline and Week 13. Mean (Standard Deviation). Unit: Percent change

Measure	Bisphosphonate IV Q4W n = 38	Denosumab 30 mg Q4W n = 40	Denosumab 120 mg Q4W n = 38	Denosumab 180 mg Q4W n = 40	Denosumab 60 mg Q12W n = 38	Denosumab 180 mg Q12W n = 40
Value	-10.19 (208.84)	-52.87 (95.14)	-54.21 (61.34)	-57.36 (41.46)	-51.73 (60.85)	-18.46 (125.86)

Bisphosphonate IV Q4W vs Denosumab 30 mg Q4W vs Denosumab 120 mg Q4W vs Denosumab 180 mg Q4W vs Denosumab 60 mg Q12W vs Denosumab 180 mg Q12W: p = 0.245, ANCOVA

Population analysed: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 25 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bisphosphonate IV Q4W	15 of 43 (34.9%)	36 of 43 (83.7%)	Not reported
Denosumab 30 mg Q4W	11 of 42 (26.2%)	33 of 42 (78.6%)	Not reported
Denosumab 120 mg Q4W	19 of 41 (46.3%)	37 of 41 (90.2%)	Not reported
Denosumab 180 mg Q4W	16 of 43 (37.2%)	36 of 43 (83.7%)	Not reported
Denosumab 60 mg Q12W	14 of 42 (33.3%)	37 of 42 (88.1%)	Not reported
Denosumab 180 mg Q12W	15 of 43 (34.9%)	35 of 43 (81.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundCampbell-Baird C, Lipton A, Sarkenshik M, Ma H, Jun S.Incidence of Acute Phase Events Following Denosumab or Intravenous Bisphosphonates: Results From a Randomized, Controlled Phase 2 Study in Patients With Breast Cancer and Bone Metastases.Journal-001752;2010;7:85-89.
Background: PubMed 18927312Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman RE, Paterson AH, Gao GM, Kinsey AC, Peterson MC, Jun S. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res. 2008 Oct 15;14(20):6690-6. doi: 10.1158/1078-0432.CCR-07-5234.
Background: PubMed 17785705Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman R, Paterson AH, Peterson MC, Fan M, Kinsey A, Jun S. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol. 2007 Oct 1;25(28):4431-7. doi: 10.1200/JCO.2007.11.8604. Epub 2007 Sep 4.
BackgroundPeterson M, Rodriquez R., Gurrola E., Sohn W, Jun S (others??).Population pharmacokinetics and pharmacodynamics of denosumab in breast cancer patients with bone metastases.Journal-000709;
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Breast Cancer

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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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Denosumab and IV Bisphosphonates in people with Breast Cancer and Metastases, 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 28 Jan 2014. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Jan 2011). 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?

Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr) (time frame: Baseline and Week 13). 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 NCT00091832, which also lists 4 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 28 Jan 2014.