A Study to Show That Treatment With Denosumab is as Good as Treatment With Risedronate in Subjects Who Are Starting to Take or Currently Taking Glucocorticoids. (GIOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01575873
First received: April 10, 2012
Last updated: June 18, 2014
Last verified: June 2014
  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 Osteporosis, Glucocorticoid-induced Osteporosis
Drug: Active denosumab with placebo for risedronate
Drug: Active risedronate with placebo for denosumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 776
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active denosumab
Investigational Product
Drug: Active denosumab with placebo for risedronate
Active denosumab with placebo for risedronate
Experimental: Placebo for denosumab
Investigational Product
Drug: Active risedronate with placebo for denosumab
Active risedronate with placebo for denosumab
Active Comparator: Active Risedronate
Investigational Product
Drug: Active risedronate with placebo for denosumab
Active risedronate with placebo for denosumab
Placebo Comparator: Placebo for Risedronate
Investigational Product
Drug: Active denosumab with placebo for risedronate
Active denosumab with placebo for risedronate

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
Genders Eligible for Study:   Both
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

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 89 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01575873     History of Changes
Other Study ID Numbers: 20101217
Study First Received: April 10, 2012
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
South Korea: Korea Food and Drug Administration (KFDA)
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Russia: Ministry of Health of the Russian Federation

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

Additional relevant MeSH terms:
Glucocorticoids
Risedronic acid
Etidronic Acid
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014