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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

Tracking Information
First Submitted Date  ICMJE April 10, 2012
First Posted Date  ICMJE April 12, 2012
Results First Submitted Date  ICMJE June 13, 2018
Results First Posted Date  ICMJE July 27, 2018
Last Update Posted Date July 27, 2018
Actual Study Start Date  ICMJE March 28, 2012
Actual Primary Completion Date June 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2012)
Bone Mineral Density [ Time Frame: 12 months ]
The study's main goal is to look at the effects on bone mineral density in the lumbar spine after one year of treatment with denosumab or risedronate in people taking glucocorticoids.
Change History Complete list of historical versions of study NCT01575873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2012)
Bone Mineral Density [ Time Frame: 12 and 24 months ]
The study will also look at the effects of denosumab and risedronate on bone mineral density at the lumbar spine and total hip individually after one year and two years of treatment. In addition, the study will look at medication side effects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
Official Title  ICMJE A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
Brief Summary This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Intervention  ICMJE
  • Drug: Denosumab
    Administered by subcutaneous injection once every 6 months
    Other Name: Prolia®
  • Drug: Placebo for risendronate
    Administered orally once a day
  • Drug: Risendronate
    Administered orally once a day
    Other Name: Actonel, Atelvia
  • Drug: Placebo for denosumab
    Administered by subcutaneous injection once every 6 months
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: Risendronate
    • Drug: Placebo for denosumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2015)
795
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2012)
776
Actual Study Completion Date  ICMJE June 29, 2017
Actual Primary Completion Date June 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Canada,   Colombia,   Czechia,   Denmark,   France,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01575873
Other Study ID Numbers  ICMJE 20101217
2010-024393-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP