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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01575873
• Date of registration: 10/04/2012
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids GIOP
• Scientific title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
• Date of first enrolment: March 28, 2012
• Target sample size: 795
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01575873
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Belgium, Canada, Colombia, Czech Republic, Czechia, Denmark, France, Germany, Hungary, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Spain, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Intervention(s)

Drug: Denosumab

Drug: Placebo for denosumab

Drug: Placebo for risendronate

Drug: Risendronate

Primary Outcome(s)

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis) [Time Frame: Baseline and month 12]

Secondary Outcome(s)

Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12 [Time Frame: Baseline and month 12]

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24 [Time Frame: Baseline and month 24]

Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis) [Time Frame: Baseline and month 12]

Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24 [Time Frame: Baseline and month 24]

Secondary ID(s)

20101217

2010-024393-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01575873