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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00980174 |
Purpose
The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men with low bone mineral density, the mean percent change in lumbar spine bone mineral density at 12 months in subjects receiving denosumab will be greater than in subjects receiving placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor Activator of Nuclear Factor-kB (RANK) Ligand that can bind and neutralize the activity of human RANK Ligand similar to the action of endogenous osteoprotegerin.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Bone Mass Low Bone Mineral Density Males With Osteoporosis Osteopenia Osteoporosis |
Drug: 60 mg denosumab Other: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Denosumab Versus Placebo in Males With Low Bone Mineral Density |
| Enrollment: | 242 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 2
Subjects will receive placebo for denosumab (SC injection every 6 months) for 1 year (double-blind phase) followed by 60 mg denosumab (SC injection every 6 months) for 1 year (open-label phase)
|
Drug: 60 mg denosumab
60 mg denosumab (SC injection every 6 months)
Other Name: denosumab
Other: Placebo
Placebo for denosumab (SC injection every 6 months)
|
|
Experimental: 1
60 mg denosumab (SC injection every 6 months) for 1 year (double-blind phase) followed by 60 mg denosumab(SC injection every 6 months) for 1 year (open-label phase). These subjects will be on denosumab for a total of 2 years.
|
Drug: 60 mg denosumab
60 mg denosumab (SC injection every 6 months)
Other Name: denosumab
|
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00980174 History of Changes |
| Other Study ID Numbers: | 20080098 |
| Study First Received: | September 17, 2009 |
| Last Updated: | August 18, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products (FAMHP); Canada: Health Canada; Denmark: Central Ethics Committee; Denmark: Danish Medicines Agency; Denmark: Laegemiddelstyrelsen; Denmark: Ministry of Health; EU: CHMP; European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; France: Ministry of Health; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Central Ethics Committee; Sweden: Lakemedelsverket; Sweden: Medical Products Agency; United States: Food and Drug Administration |
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men male denosumab BMD lumbar spine |
ADAMO The ADAMO Trial male osteoporosis osteoporosis in men males with low bone mineral density |
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Bone Diseases, Metabolic Osteoporosis Bone Diseases Musculoskeletal Diseases |