Steroid-induced Osteopor, Glucocorticoid-induced OsteporPhase 3GIOPNCT01575873

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

A Phase 3 study testing Denosumab and Risendronate in people with Steroid-induced Osteopor, Glucocorticoid-induced Ostepor, run by Amgen at 99 sites in 16 countries.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
What is being tested?: Denosumab and Risendronate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 795 participants
Where: 99 sitesin 16 countries
Study dates: 28 Mar 2012to 29 Jun 2017
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

99 sites in 16 countries.

Country

City, postcode or hospital

99 sites in 16 countries

United States18 sites

Research Site
Beckley, West Virginia, 25801
Research Site
Bethesda, Maryland, 20817
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Birmingham, Alabama, 35294
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Boston, Massachusetts, 02118
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Chicago, Illinois, 60611
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Cumberland, Maryland, 21502
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Detroit, Michigan, 48236
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Duncansville, Pennsylvania, 16635
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Evanston, Illinois, 60201
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Fargo, North Dakota, 58103
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Fargo, North Dakota, 58104
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Gainesville, Georgia, 30501
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Indianapolis, Indiana, 46202
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Lakewood, Colorado, 80227
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Mayfield, Ohio, 44143
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Pembroke Pines, Florida, 33029
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Sacramento, California, 95817
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Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada10 sites

Research Site
Barrie, Ontario, L4M 6L2
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Hamilton, Ontario, L8N 1Y2
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Montreal, Quebec, H2L 1S6
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Montreal, Quebec, H3Z 2Z3
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Québec, Quebec, G1V 3M7
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Saskatoon, Saskatchewan, S7K 0H6
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Trois-Rivières, Quebec, G8Z 1Y2
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Vancouver, British Columbia, V5Z 4E1
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Waterloo, Ontario, N2J 1C4
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Westmout, Quebec, H3Z 1E5

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Poland10 sites

Research Site
Bialystok, 15-879
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Krakow, 31-501
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Lodz, 90-368
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Poznan, 60-218
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Poznan, 60-356
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Stalowa Wola, 37-450
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Torun, 87-100
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Warsaw, 01-192
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Warsaw, 04-730
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Wroclaw, 51-124

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Russia8 sites

Research Site
Moscow, 105077
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Moscow, 115522
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Nizhny Novgorod, 603155
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Saint Petersburg, 190068
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Saint Petersburg, 190103
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Saint Petersburg, 194291
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Yaroslavl, 150003
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Yekaterinburg, 620102

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Czechia7 sites

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Brno, 602 00
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Pardubice, 530 02
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Pilsen, 305 99
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Prague, 128 50
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Prague, 130 00
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Praha 11 - Chodov, 148 00
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Uherské Hradiště, 686 01

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South Korea7 sites

Research Site
Daegu, 700-712
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Daejeon, 301-721
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Gwangju, 501-757
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Jinju, 660-702
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Seoul, 120-752
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Seoul, 137-701
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Seoul, 150-713

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Germany6 sites

Research Site
Bad Nauheim, 61231
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Bad Reichenhall, 83435
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Berlin, 10117
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Cologne, 50937
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Hildesheim, 31134
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Vogelsang-Gommern, 39245

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Hungary6 sites

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Budapest, 1023
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Budapest, 1036
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Debrecen, 4032
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Gyula, 5700
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Szeged, 6720
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Szikszó, 3800

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Belgium5 sites

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Brussels, 1200
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Genk, 3600
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Ghent, 9000
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Liège, 4000
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Wilrijk, 2610

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Denmark4 sites

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Aalborg, 9000
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Århus C, 8000
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Ballerup Municipality, 2750
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Vejle, 7100

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Mexico4 sites

Research Site
León, Guanajuato, 37000
Research Site
Mexico City, Mexico City, 06100
Research Site
Morelia, Michoacán, 58070
Research Site
San Luis Potosí City, San Luis Potosí, 78200

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Spain4 sites

Research Site
Barcelona, Catalonia, 08041
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Madrid, 28006
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Madrid, 28046
Research Site
Valencia, Valencia, 46026

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Argentina3 sites

Research Site
Buenos Aires, C1431FBO
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1114
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

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France3 sites

Research Site
Lyon Cédex 3, 69437
Research Site
Orléans, 45067
Research Site
Vandœuvre-lès-Nancy, 54511

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Netherlands3 sites

Research Site
Amsterdam, 1081 HV
Research Site
Helmond, 5707 HA
Research Site
Utrecht, 3584 XC

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Colombia1 site

Research Site
Barranquilla, Atlántico, 08001000

Other trials in Colombia

About this study

Official title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

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
Being tested: Denosumab, Placebo for risendronate, Risendronate, Placebo for denosumab
Keywords: GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density

What participants receive

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

DenosumabDrug
Also called Prolia®
Administered by subcutaneous injection once every 6 months
Placebo for risendronateDrug
Administered orally once a day
RisendronateDrug
Also called Actonel, Atelvia
Administered orally once a day
Placebo for denosumabDrug
Administered by subcutaneous injection once every 6 months

Study groups in NCT01575873
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Risendronate; Drug: Placebo for denosumab

What is being measured

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

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).
Measured: Baseline and month 12

Secondary outcomes (4)

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).
Measured: Baseline and month 12
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).
Measured: Baseline and month 12
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).
Measured: Baseline and month 24
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).
Measured: Baseline and month 24

Timeline

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

28 Mar 201229 Jun 2017

First posted12 Apr 2012 (estimated)
Study start28 Mar 2012
Primary completion21 Jun 2016
Study completion29 Jun 2017

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 (2)Papers the sponsor has linked to this study.
Other trials for Steroid-induced Osteopor, Glucocorticoid-induced OsteporStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 795 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01575873
Sponsor's protocol ID: 20101217
Other IDs: 2010-024393-19
Acronym: GIOP
Status last verified: Jul 2018
First submitted: 10 Apr 2012
Last updated: 27 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
ClinicalTrials.gov ID: NCT01575873
Acronym / sponsor ID: GIOP / 20101217
Conditions: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Keywords: GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 795 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 28 Mar 2012 (actual)
Primary completion: 21 Jun 2016 (actual)
Study completion: 29 Jun 2017 (actual)
First posted: 12 Apr 2012 (estimated)
Results: Posted 27 Jul 2018

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Denosumab	Experimental	Drug: Denosumab, Drug: Placebo for risendronateParticipants 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.
Risendronate	Experimental	Drug: Risendronate, Drug: Placebo for denosumabParticipants 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.

Who may qualify

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

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

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®Administered by subcutaneous injection once every 6 months	Drug	Denosumab
Placebo for risendronateAdministered orally once a day	Drug	Denosumab
RisendronateAlso: Actonel, AtelviaAdministered orally once a day	Drug	Risendronate
Placebo for denosumabAdministered by subcutaneous injection once every 6 months	Drug	Risendronate

Primary outcome

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)
Time frame: Baseline and month 12
Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

4 secondary outcomes

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)
Time frame: Baseline and month 12
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12
Time frame: Baseline and month 12
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24
Time frame: Baseline and month 24
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24
Time frame: Baseline and month 24

Results and safety

Results posted to the registry on 27 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Risedronate: Glucocorticoid-initiating	145	117
Denosumab: Glucocorticoid-initiating	145	109
Risedronate: Glucocorticoid-continuing	252	178
Denosumab: Glucocorticoid-continuing	253	186

Primary outcome: Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)

Time frame: Baseline and month 12. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	Risedronate: Glucocorticoid-initiating n = 126	Denosumab: Glucocorticoid-initiating n = 119	Risedronate: Glucocorticoid-continuing n = 211	Denosumab: Glucocorticoid-continuing n = 209
Value	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)

Risedronate: Glucocorticoid-initiating vs Denosumab: Glucocorticoid-initiating: LS Mean Difference: 2.9 (95% CI 2.0 to 3.9), p < 0.001, ANCOVA
Risedronate: Glucocorticoid-continuing vs Denosumab: Glucocorticoid-continuing: LS Mean Difference: 2.2 (95% CI 1.4 to 3.0), p < 0.001, ANCOVA

Population analysed: Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Risedronate	98 of 385 (25.5%)	76 of 385 (19.7%)	9 of 385
Denosumab	92 of 394 (23.4%)	77 of 394 (19.5%)	13 of 394

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29631782Saag 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.
Derived from this study: PubMed 30816640Saag 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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

99 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Denosumab and Risendronate in people with Steroid-induced Osteopor, Glucocorticoid-induced Ostepor, run by Amgen at 99 sites in 16 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 1 inclusion and 1 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 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Canada, Poland, Russia, Czechia and 11 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. 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 27 Jul 2018). 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 in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis) (time frame: Baseline and month 12). 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 NCT01575873, which also lists 2 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 27 Jul 2018.