Overview

This trial is active, not recruiting.

Condition steroid-induced osteopor., glucocorticoid-induced ostepor.
Treatments active denosumab with placebo for risedronate, active risedronate with placebo for denosumab
Phase phase 3
Sponsor Amgen
Start date March 2012
End date June 2016
Trial size 795 participants
Trial identifier NCT01575873, 20101217

Summary

This study is being conducted in patients taking glucocorticoids for treatment of various diseases. It is a 2-year study that will compare the effects of denosumab and risedronate.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Investigational Product
active denosumab with placebo for risedronate
Active denosumab with placebo for risedronate
(Experimental)
Investigational Product
active risedronate with placebo for denosumab
Active risedronate with placebo for denosumab
(Active Comparator)
Investigational Product
active risedronate with placebo for denosumab
Active risedronate with placebo for denosumab
(Placebo Comparator)
Investigational Product
active denosumab with placebo for risedronate
Active denosumab with placebo for risedronate

Primary Outcomes

Measure
Bone Mineral Density
time frame: 12 months

Secondary Outcomes

Measure
Bone Mineral Density
time frame: 12 and 24 months
Bone histology
time frame: 12 and 24 Months
Bone histomorphometry
time frame: 12 & 24 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
Description This is a 2-year study that will compare the effects of denosumab and risedronate in people who are taking glucocorticoid therapy. The study will look at bone mineral density (BMD) at the spine and hip during two years of treatment. Other endpoints will include changes in wrist characteristics measured by QCT, satisfaction with treatment, effects on biochemical markers of bone turnover (blood tests that can measure bone health), fracture rates, and effects on bone histology (characteristics of bone that can be studied under a microscope).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Amgen.