Phase 3 N=795 Randomized Triple-blind Treatment

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

Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Bottom Line

View on ClinicalTrials.gov: NCT01575873 ↗

Enrolled (actual)

795

Serious AEs

24.4%

Results posted

Jul 2018

Primary outcome: 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 percent change — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Denosumab (Drug); Placebo for risendronate (Drug); Risendronate (Drug); Placebo for denosumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Jun 2016

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

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01575873). 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.