Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
Summary
Linked Publications (2)
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Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study.
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Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis) |
0.8; 3.8; 2.3; 4.4 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis) |
0.8; 3.8; 2.3; 4.4 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12 |
0.2; 1.7; 0.6; 2.1 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24 |
1.7; 6.2; 3.2; 6.4 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24 |
-0.0; 3.1; 0.5; 2.9 | < 0.001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01575873) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.