MedTrace Logo

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

NCT01575873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2018-07-27

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Interventions

DRUG

Denosumab

Administered by subcutaneous injection once every 6 months

DRUG

Placebo for risendronate

Administered orally once a day

DRUG

Risendronate

Administered orally once a day

DRUG

Placebo for denosumab

Administered by subcutaneous injection once every 6 months

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-28
Primary Completion
2016-06-21
Completion
2017-06-29

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01575873 on ClinicalTrials.gov