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

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

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

Conditions
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Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Intervention / Treatment
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* Drug: Denosumab
* Drug: Placebo for risendronate
* Drug: Risendronate
* Drug: Placebo for denosumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab<br>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<br>* Administered by subcutaneous injection once every 6 months<br>* Other names: Prolia®;Drug: Placebo for risendronate<br>* Administered orally once a day<br>|
| Experimental: Risendronate<br>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<br>* Administered orally once a day<br>* Other names: Actonel, Atelvia;Drug: Placebo for denosumab<br>* Administered by subcutaneous injection once every 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | Baseline and month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density