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CompletedNCT01575873GIOPUpdated Jul 27, 2018Results posted

Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids

A Phase 3 interventional study of Denosumab and Placebo for risendronate in Steroid-induced Osteopor, Glucocorticoid-induced Ostepor, sponsored by Amgen. Completed at 99 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-27.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
795
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

02

Conditions studied

  • Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Keywords

  • GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density
03

In context

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men and women who are less than 50 years of age must have had a fracture as an adult to be eligible. Men and women who are 50 years of age or older who have been taking glucocorticoids must meet protocol-specific BMD criteria.

Exclusion criteria

Exclusion Criteria:

Use of agents affecting bone metabolism, use of more than one biologic agent for inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level (one can enter the trial after vitamin D levels are corrected), abnormalities of blood calcium, an underactive or overactive thyroid condition that is not treated and stable, Addison's disease, any abnormality of the parathyroid glands (the glands that control blood calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
795 participants (actual)

Study arms

  • Experimental
    Denosumab

    Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.

    Drug: Denosumab · Drug: Placebo for risendronate

  • Experimental
    Risendronate

    Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.

    Drug: Risendronate · Drug: Placebo for denosumab

Interventions

  • DrugDenosumab

    Administered by subcutaneous injection once every 6 months

    Also known as: Prolia®

  • DrugPlacebo for risendronate

    Administered orally once a day

  • DrugRisendronate

    Administered orally once a day

    Also known as: Actonel, Atelvia

  • DrugPlacebo for denosumab

    Administered by subcutaneous injection once every 6 months

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)

    Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

    Time frame: Baseline and month 12

Secondary outcomes

  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)

    Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

    Time frame: Baseline and month 12

  2. Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12

    Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).

    Time frame: Baseline and month 12

  3. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24

    Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

    Time frame: Baseline and month 24

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

    Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).

    Time frame: Baseline and month 24

07

Results

Posted Jul 27, 2018

Participant flow

Participants were enrolled at 79 centers in Europe, North America, Latin America, and Korea from 28 March 2012 to 30 June 2015. Participants who had been taking glucocorticoids for at least 3 months were classed as glucocorticoid continuing; those who were taking glucocorticoids for less than 3 months were classed as glucocorticoid initiating.

Participant flow — Overall Study
MilestoneRisedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuing
Started145145252253
Received study drug140142246251
Completed117109178186
Not completed28367467
Withdrew: Withdrawal by subject15203434
Withdrew: Adverse event77912
Withdrew: Lost to follow-up13135
Withdrew: Death3289
Withdrew: Noncompliance1243
Withdrew: Administrative decision1110
Withdrew: Protocol deviation0101
Withdrew: Requirement for alternative therapy0011
Withdrew: Other0042

Outcome measures

PrimaryPercent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)

Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

Time frame:
Baseline and month 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)
percent changeRisedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuing
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)0.8 (0.2 to 1.5)3.8 (3.1 to 4.5)2.3 (1.7 to 2.9)4.4 (3.8 to 5.0)
Statistical analysis
  • Risedronate: Glucocorticoid-initiating vs Denosumab: Glucocorticoid-initiating · ANCOVA · p = < 0.001 (One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.) · Ls mean difference: 2.9 · 95% CI 2.0 to 3.9Least Squares (LS) Mean Difference = Denosumab - Risedronate
  • Risedronate: Glucocorticoid-continuing vs Denosumab: Glucocorticoid-continuing · ANCOVA · p = < 0.001 (One-sided p-value based on the prespecified noninferiority margins for lumbar spine of -0.7%.) · Ls mean difference: 2.2 · 95% CI 1.4 to 3.0LS Mean Difference = Denosumab - Risedronate
SecondaryPercent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)

Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

Time frame:
Baseline and month 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)
percent changeRisedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuing
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)0.8 (0.2 to 1.5)3.8 (3.1 to 4.5)2.3 (1.7 to 2.9)4.4 (3.8 to 5.0)
Statistical analysis
  • Risedronate: Glucocorticoid-initiating vs Denosumab: Glucocorticoid-initiating · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 2.9 · 95% CI 2.0 to 3.9LS Mean Difference = Denosumab - Risedronate
  • Risedronate: Glucocorticoid-continuing vs Denosumab: Glucocorticoid-continuing · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 2.2 · 95% CI 1.4 to 3.0LS Mean Difference = Denosumab - Risedronate
SecondaryPercent Change From Baseline in Total Hip Bone Mineral Density at Month 12

Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).

Time frame:
Baseline and month 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12
percent changeRisedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuing
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 120.2 (-0.2 to 0.7)1.7 (1.2 to 2.2)0.6 (0.2 to 1.0)2.1 (1.7 to 2.5)
Statistical analysis
  • Risedronate: Glucocorticoid-initiating vs Denosumab: Glucocorticoid-initiating · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 1.5 · 95% CI 0.8 to 2.1LS Mean Difference = Denosumab - Risedronate
  • Risedronate: Glucocorticoid-continuing vs Denosumab: Glucocorticoid-continuing · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 1.5 · 95% CI 1.0 to 2.1LS Mean Difference = Denosumab - Risedronate
SecondaryPercent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24

Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

Time frame:
Baseline and month 24
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24
percent changeRisedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuing
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 241.7 (0.8 to 2.7)6.2 (5.3 to 7.2)3.2 (2.3 to 4.1)6.4 (5.5 to 7.2)
Statistical analysis
  • Risedronate: Glucocorticoid-initiating vs Denosumab: Glucocorticoid-initiating · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 4.5 · 95% CI 3.2 to 5.8LS Mean Difference = Denosumab - Risedronate
  • Risedronate: Glucocorticoid-continuing vs Denosumab: Glucocorticoid-continuing · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 3.2 · 95% CI 2.0 to 4.3LS Mean Difference = Denosumab - Risedronate
SecondaryPercent Change From Baseline in Total Hip Bone Mineral Density at Month 24

Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).

Time frame:
Baseline and month 24
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24
percent changeRisedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuing
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24-0.0 (-0.6 to 0.6)3.1 (2.4 to 3.7)0.5 (-0.1 to 1.0)2.9 (2.4 to 3.5)
Statistical analysis
  • Risedronate: Glucocorticoid-initiating vs Denosumab: Glucocorticoid-initiating · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 3.1 · 95% CI 2.2 to 3.9LS Mean Difference = Denosumab - Risedronate
  • Risedronate: Glucocorticoid-continuing vs Denosumab: Glucocorticoid-continuing · ANCOVA · p = < 0.001 (2-sided p-value corresponding to the 2-sided 95% confidence interval) · Ls mean difference: 2.5 · 95% CI 1.7 to 3.2LS Mean Difference = Denosumab - Risedronate

Adverse events

Collected over 24 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Risedronate9/385 (2.3%)98/385 (25.5%)76/385 (19.7%)
Denosumab13/394 (3.3%)92/394 (23.4%)77/394 (19.5%)
Most frequent serious events
Showing 10 of 220
Most frequent serious events
EventRisedronateDenosumab
PneumoniaInfections and infestations8/3857/394
OsteoarthritisMusculoskeletal and connective tissue disorders5/3852/394
Pulmonary embolismRespiratory, thoracic and mediastinal disorders5/3850/394
Back painMusculoskeletal and connective tissue disorders3/3851/394
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders3/3851/394
Cardiac failureCardiac disorders0/3853/394
Femur fractureInjury, poisoning and procedural complications0/3853/394
Cerebrovascular accidentNervous system disorders1/3853/394
Transient ischaemic attackNervous system disorders1/3853/394
AnaemiaBlood and lymphatic system disorders2/3851/394
Most frequent other events
Most frequent other events
EventRisedronateDenosumab
ArthralgiaMusculoskeletal and connective tissue disorders33/38523/394
Back painMusculoskeletal and connective tissue disorders21/38524/394
HypertensionVascular disorders15/38521/394
Viral upper respiratory tract infectionInfections and infestations19/38520/394

Baseline characteristics

Age, Continuous
Age, Continuous(years)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
Mean64.4 ± 10.067.5 ± 10.161.3 ± 11.161.5 ± 11.663.1 ± 11.1
Age, Customized
Age, Customized(Participants)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
< 50 years52263366
50 - 64 years7555130114374
65 - 74 years38506273223
≥ 75 years27383433132
Sex: Female, Male
Sex: Female, Male(Participants)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
Female9393185185556
Male52526768239
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
Hispanic or Latino18205443135
Not Hispanic or Latino127125198210660
Unknown or Not Reported00000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
White123122223230698
Other1112111347
Asian9912636
Black or African American224412
American Indian or Alaska Native00101
Multiple00101
Menopausal Status
Menopausal Status(Participants)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
Premenopause710252466
Postmenopause8382157159481
Unknown31329
Lumbar Spine Bone Mineral Density (BMD) T-score
Lumbar Spine Bone Mineral Density (BMD) T-score(T-score)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
Glucocorticoid-initiating Subpopulation-1.06 ± 1.57-0.92 ± 1.86——-0.99 ± 1.72
Glucocorticoid-continuing Subpopulation——-1.96 ± 1.38-1.92 ± 1.38-1.94 ± 1.38
Total Hip BMD T-score
Total Hip BMD T-score(T-score)Risedronate: Glucocorticoid-initiatingDenosumab: Glucocorticoid-initiatingRisedronate: Glucocorticoid-continuingDenosumab: Glucocorticoid-continuingTotal
Glucocorticoid-initiating Subpopulation-0.98 ± 1.07-1.14 ± 1.00——-1.06 ± 1.04
Glucocorticoid-continuing Subpopulation——-1.56 ± 0.96-1.66 ± 0.96-1.61 ± 0.96
08

Study locations

99 sites
  • Research Site
    Birmingham, Alabama 35294, United States
  • Research Site
    Sacramento, California 95817, United States
  • Research Site
    Lakewood, Colorado 80227, United States
  • Research Site
    Pembroke Pines, Florida 33029, United States
  • Research Site
    Gainesville, Georgia 30501, United States
  • Research Site
    Chicago, Illinois 60611, United States
  • Research Site
    Evanston, Illinois 60201, United States
  • Research Site
    Indianapolis, Indiana 46202, United States
  • Research Site
    Bethesda, Maryland 20817, United States
  • Research Site
    Cumberland, Maryland 21502, United States
  • Research Site
    Boston, Massachusetts 02118, United States
  • Research Site
    Detroit, Michigan 48236, United States
  • Research Site
    Fargo, North Dakota 58103, United States
  • Research Site
    Fargo, North Dakota 58104, United States
  • Research Site
    Mayfield, Ohio 44143, United States
  • Research Site
    Duncansville, Pennsylvania 16635, United States
  • Research Site
    Wyomissing, Pennsylvania 19610, United States
  • Research Site
    Beckley, West Virginia 25801, United States
  • Research Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires 1114, Argentina
  • Research Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina
  • Research Site
    Buenos Aires, C1431FBO, Argentina
  • Research Site
    Bruxelles, 1200, Belgium
  • Research Site
    Genk, 3600, Belgium
  • Research Site
    Gent, 9000, Belgium
  • Research Site
    Liege, 4000, Belgium
  • Research Site
    Wilrijk, 2610, Belgium
  • Research Site
    Vancouver, British Columbia V5Z 4E1, Canada
  • Research Site
    Barrie, Ontario L4M 6L2, Canada
  • Research Site
    Hamilton, Ontario L8N 1Y2, Canada
  • Research Site
    Waterloo, Ontario N2J 1C4, Canada
  • Research Site
    Montreal, Quebec H2L 1S6, Canada
  • Research Site
    Montreal, Quebec H3Z 2Z3, Canada
  • Research Site
    Trois-Rivieres, Quebec G8Z 1Y2, Canada
  • Research Site
    Westmout, Quebec H3Z 1E5, Canada
  • Research Site
    Saskatoon, Saskatchewan S7K 0H6, Canada
  • Research Site
    Quebec, G1V 3M7, Canada
  • Research Site
    Barranquilla, Atlántico 08001000, Colombia
  • Research Site
    Brno, 602 00, Czechia
  • Research Site
    Pardubice, 530 02, Czechia
  • Research Site
    Plzen, 305 99, Czechia
  • Research Site
    Praha 11 - Chodov, 148 00, Czechia
  • Research Site
    Praha 2, 128 50, Czechia
  • Research Site
    Praha 3, 130 00, Czechia
  • Research Site
    Uherske Hradiste, 686 01, Czechia
  • Research Site
    Aalborg, 9000, Denmark
  • Research Site
    Ballerup, 2750, Denmark
  • Research Site
    Vejle, 7100, Denmark
  • Research Site
    Århus C, 8000, Denmark
  • Research Site
    Lyon Cédex 3, 69437, France
  • Research Site
    Orleans Cedex, 45067, France
  • Research Site
    Vandoeuvre les Nancy, 54511, France
  • Research Site
    Bad Nauheim, 61231, Germany
  • Research Site
    Bad Reichenhall, 83435, Germany
  • Research Site
    Berlin, 10117, Germany
  • Research Site
    Hildesheim, 31134, Germany
  • Research Site
    Köln, 50937, Germany
  • Research Site
    Vogelsang-Gommern, 39245, Germany
  • Research Site
    Budapest, 1023, Hungary
  • Research Site
    Budapest, 1036, Hungary
  • Research Site
    Debrecen, 4032, Hungary
  • Research Site
    Gyula, 5700, Hungary
  • Research Site
    Szeged, 6720, Hungary
  • Research Site
    Szikszo, 3800, Hungary
  • Research Site
    Daegu, 700-712, Korea, Republic of
  • Research Site
    Daejeon, 301-721, Korea, Republic of
  • Research Site
    Gwangju, 501-757, Korea, Republic of
  • Research Site
    Jinju-si, 660-702, Korea, Republic of
  • Research Site
    Seoul, 120-752, Korea, Republic of
  • Research Site
    Seoul, 137-701, Korea, Republic of
  • Research Site
    Seoul, 150-713, Korea, Republic of
  • Research Site
    Mexico, Distrito Federal 06100, Mexico
  • Research Site
    Leon, Guanajuato 37000, Mexico
  • Research Site
    Morelia, Michoacán 58070, Mexico
  • Research Site
    San Luis Potosi, San Luis Potosí 78200, Mexico
  • Research Site
    Amsterdam, 1081 HV, Netherlands
  • Research Site
    Helmond, 5707 HA, Netherlands
  • Research Site
    Utrecht, 3584 XC, Netherlands
  • Research Site
    Bialystok, 15-879, Poland
  • Research Site
    Kraków, 31-501, Poland
  • Research Site
    Lodz, 90-368, Poland
  • Research Site
    Poznan, 60-218, Poland
  • Research Site
    Poznan, 60-356, Poland
  • Research Site
    Stalowa Wola, 37-450, Poland
  • Research Site
    Torun, 87-100, Poland
  • Research Site
    Warszawa, 01-192, Poland
  • Research Site
    Warszawa, 04-730, Poland
  • Research Site
    Wroclaw, 51-124, Poland
  • Research Site
    Ekaterinburg, 620102, Russian Federation
  • Research Site
    Moscow, 105077, Russian Federation
  • Research Site
    Moscow, 115522, Russian Federation
  • Research Site
    Nizhniy Novgorod, 603155, Russian Federation
  • Research Site
    Saint Petersburg, 190103, Russian Federation
  • Research Site
    Saint Petersburg, 194291, Russian Federation
  • Research Site
    Saint-Petersburg, 190068, Russian Federation
  • Research Site
    Yaroslavl, 150003, Russian Federation
  • Research Site
    Barcelona, Cataluña 08041, Spain
  • Research Site
    Valencia, Comunidad Valenciana 46026, Spain
  • Research Site
    Madrid, 28006, Spain
  • Research Site
    Madrid, 28046, Spain
09

References and documents

Publications

  • Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454. doi: 10.1016/S2213-8587(18)30075-5. Epub 2018 Apr 6. PubMed 29631782 ↗
  • Saag KG, Pannacciulli N, Geusens P, Adachi JD, Messina OD, Morales-Torres J, Emkey R, Butler PW, Yin X, Lems WF. Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial. Arthritis Rheumatol. 2019 Jul;71(7):1174-1184. doi: 10.1002/art.40874. Epub 2019 May 25. PubMed 30816640 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01575873
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Apr 12, 2012
Start date
Mar 28, 2012
Primary completion
Jun 21, 2016
Completion
Jun 29, 2017
Results posted
Jul 27, 2018
Last update
Jul 27, 2018

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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