ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00325468
Recruitment Status : Completed
First Posted : May 12, 2006
Results First Posted : July 30, 2013
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Condition or disease Intervention/treatment Phase
Low Bone Mineral Density Drug: AMG 162 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Actual Study Start Date : May 1, 2006
Actual Primary Completion Date : March 28, 2011
Actual Study Completion Date : August 2, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AMG 162
AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
Drug: AMG 162
AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42



Primary Outcome Measures :
  1. Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ]
  2. Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ]
  3. Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ]

Secondary Outcome Measures :
  1. Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ]
  2. Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be ambulatory
  • Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
  • signed informed consent must be obtained before any study-specific procedures

Exclusion Criteria:

  • Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
  • Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
  • Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
  • Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325468


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00325468     History of Changes
Other Study ID Numbers: 20050233
First Posted: May 12, 2006    Key Record Dates
Results First Posted: July 30, 2013
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Amgen:
bone loss
osteoporosis

Additional relevant MeSH terms:
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs