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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575873
Recruitment Status : Completed
First Posted : April 12, 2012
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Steroid-induced Osteopor, Glucocorticoid-induced Ostepor Drug: Denosumab Drug: Placebo for risendronate Drug: Risendronate Drug: Placebo for denosumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 795 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
Actual Study Start Date : March 28, 2012
Actual Primary Completion Date : June 21, 2016
Actual Study Completion Date : June 29, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Administered by subcutaneous injection once every 6 months
Other Name: Prolia®

Drug: Placebo for risendronate
Administered orally once a day
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
Administered orally once a day
Other Name: Actonel, Atelvia

Drug: Placebo for denosumab
Administered by subcutaneous injection once every 6 months


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis) [ Time Frame: Baseline and month 12 ]
    Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

  2. Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12 [ Time Frame: Baseline and month 12 ]
    Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).

  3. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24 [ Time Frame: Baseline and month 24 ]
    Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).

  4. Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24 [ Time Frame: Baseline and month 24 ]
    Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575873


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01575873    
Other Study ID Numbers: 20101217
2010-024393-19 ( EudraCT Number )
First Posted: April 12, 2012    Key Record Dates
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018
Last Verified: July 2018
Keywords provided by Amgen:
GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density
Additional relevant MeSH terms:
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Denosumab
Risedronic Acid
Glucocorticoids
Bone Density Conservation Agents
Physiological Effects of Drugs
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents