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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 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 |

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 |
- 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).
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
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.

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

Study Director: | MD | Amgen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density |
Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |