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

NCT01575873 | Completed Phase 3 Results DMC

• 2 other identifiers: 201012172010-024393-19
• Study Type: interventional
• Target: 795
• Locations: 16 countries
• Sites: 99

Brief Summary

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

Conditions

Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Keywords

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

Outcome Measures

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).

  Baseline and month 12

Secondary Outcomes (4)

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

  Baseline and month 12

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

  Baseline and month 12

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

  Baseline and month 24

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

  Baseline and month 24

Study Arms (2)

Denosumab

EXPERIMENTAL

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

Risendronate

EXPERIMENTAL

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

Denosumab DRUG

Administered by subcutaneous injection once every 6 months

Also known as: Prolia®

Denosumab

Placebo for risendronate DRUG

Administered orally once a day

Denosumab

Risendronate DRUG

Administered orally once a day

Also known as: Actonel, Atelvia

Risendronate

Placebo for denosumab DRUG

Administered by subcutaneous injection once every 6 months

Risendronate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (99)

Research Site

Birmingham, Alabama, 35294, United States

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Sacramento, California, 95817, United States

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Lakewood, Colorado, 80227, United States

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Pembroke Pines, Florida, 33029, United States

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Gainesville, Georgia, 30501, United States

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Chicago, Illinois, 60611, United States

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Evanston, Illinois, 60201, United States

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Indianapolis, Indiana, 46202, United States

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Bethesda, Maryland, 20817, United States

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Cumberland, Maryland, 21502, United States

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Boston, Massachusetts, 02118, United States

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Detroit, Michigan, 48236, United States

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Fargo, North Dakota, 58103, United States

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Fargo, North Dakota, 58104, United States

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Mayfield, Ohio, 44143, United States

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Duncansville, Pennsylvania, 16635, United States

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Wyomissing, Pennsylvania, 19610, United States

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Beckley, West Virginia, 25801, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1114, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina

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Buenos Aires, C1431FBO, Argentina

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Brussels, 1200, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Liège, 4000, Belgium

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Wilrijk, 2610, Belgium

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Vancouver, British Columbia, V5Z 4E1, Canada

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Barrie, Ontario, L4M 6L2, Canada

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Hamilton, Ontario, L8N 1Y2, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Montreal, Quebec, H2L 1S6, Canada

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Montreal, Quebec, H3Z 2Z3, Canada

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Québec, Quebec, G1V 3M7, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Westmout, Quebec, H3Z 1E5, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Barranquilla, Atlántico, 08001000, Colombia

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Brno, 602 00, Czechia

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Pardubice, 530 02, Czechia

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Pilsen, 305 99, Czechia

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Prague, 128 50, Czechia

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Prague, 130 00, Czechia

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Praha 11 - Chodov, 148 00, Czechia

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Uherské Hradiště, 686 01, Czechia

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Aalborg, 9000, Denmark

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Århus C, 8000, Denmark

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Ballerup Municipality, 2750, Denmark

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Vejle, 7100, Denmark

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Lyon Cédex 3, 69437, France

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Orléans, 45067, France

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Vandœuvre-lès-Nancy, 54511, France

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Bad Nauheim, 61231, Germany

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Bad Reichenhall, 83435, Germany

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Berlin, 10117, Germany

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Cologne, 50937, Germany

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Hildesheim, 31134, Germany

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Vogelsang-Gommern, 39245, Germany

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Budapest, 1023, Hungary

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Budapest, 1036, Hungary

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Debrecen, 4032, Hungary

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Gyula, 5700, Hungary

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Szeged, 6720, Hungary

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Szikszó, 3800, Hungary

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León, Guanajuato, 37000, Mexico

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Mexico City, Mexico City, 06100, Mexico

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Morelia, Michoacán, 58070, Mexico

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San Luis Potosí City, San Luis Potosí, 78200, Mexico

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Amsterdam, 1081 HV, Netherlands

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Helmond, 5707 HA, Netherlands

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Utrecht, 3584 XC, Netherlands

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Bialystok, 15-879, Poland

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Krakow, 31-501, Poland

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Lodz, 90-368, Poland

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Poznan, 60-218, Poland

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Poznan, 60-356, Poland

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Stalowa Wola, 37-450, Poland

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Torun, 87-100, Poland

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Warsaw, 01-192, Poland

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Warsaw, 04-730, Poland

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Wroclaw, 51-124, Poland

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Moscow, 105077, Russia

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Moscow, 115522, Russia

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Nizhny Novgorod, 603155, Russia

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Saint Petersburg, 190068, Russia

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Saint Petersburg, 190103, Russia

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Saint Petersburg, 194291, Russia

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Yaroslavl, 150003, Russia

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Yekaterinburg, 620102, Russia

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Daegu, 700-712, South Korea

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Daejeon, 301-721, South Korea

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Gwangju, 501-757, South Korea

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Jinju, 660-702, South Korea

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Seoul, 120-752, South Korea

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Seoul, 137-701, South Korea

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Seoul, 150-713, South Korea

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Barcelona, Catalonia, 08041, Spain

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Valencia, Valencia, 46026, Spain

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Madrid, 28006, Spain

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Madrid, 28046, Spain

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Related Publications (2)

• 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.

  PMID: 29631782 BACKGROUND

• 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.

  PMID: 30816640 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Denosumab; Risedronic Acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: March 28, 2012
• Primary Completion: June 21, 2016
• Study Completion: June 29, 2017
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-07

Locations

NL (3); PL (10); CZ (7); KR (7); ES (4); HU (6); AR (3); BE (5); ME (4); US (18); DK (4); FR (3); CA (10); CO (1); RU (8); DE (6)