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)
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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 |
- 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.
- 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: | November 2015 |
| Estimated Primary Completion Date: | November 2014 (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 |
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| Contact: Amgen Call Center | 866-572-6436 |
Show 63 Study Locations| 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: | April 1, 2013 |
| 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 May 23, 2013