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A Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids (GIOP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01575873
First received: April 10, 2012
Last updated: May 26, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Steroid-induced Osteopor, Glucocorticoid-induced Ostepor Drug: Active denosumab Drug: Placebo for risendronate Drug: Active risendronate Drug: Placebo for denosumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 12 months ]
    The study's main goal is to look at the effects on bone mineral density in the lumbar spine after one year of treatment with denosumab or risedronate in people taking glucocorticoids.


Secondary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 12 and 24 months ]
    The study will also look at the effects of denosumab and risedronate on bone mineral density at the lumbar spine and total hip individually after one year and two years of treatment. In addition, the study will look at medication side effects.

  • Bone histology [ Time Frame: 12 and 24 Months ]
    Bone Biopsy Substudy

  • Bone histomorphometry [ Time Frame: 12 & 24 Months ]
    Bone Biopsy Substudy


Enrollment: 795
Actual Study Start Date: March 28, 2012
Estimated Study Completion Date: June 30, 2017
Primary Completion Date: June 21, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active denosumab + Placebo Risedronate
Investigational Product
Drug: Active denosumab
Active denosumab with placebo for risedronate
Drug: Active risendronate
Active denosumab will be administered with placebo residronate
Experimental: Active Risendronate + Placebo Denosumab
Investigational Product
Drug: Placebo for risendronate
Active risedronate will be administered with placebo denosumab
Drug: Placebo for denosumab
Active residronate will be administered with placebo denosumab

Detailed 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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575873

  Show 99 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01575873     History of Changes
Other Study ID Numbers: 20101217
Study First Received: April 10, 2012
Last Updated: May 26, 2017

Keywords provided by Amgen:
GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density

Additional relevant MeSH terms:
Denosumab
Risedronate Sodium
Etidronic Acid
Glucocorticoids
Bone Density Conservation Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017