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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00325468
First received: May 10, 2006
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Low Bone Mineral Density
Drug: AMG 162
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8 [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2006
Study Completion Date: August 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders 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.
  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: NCT00325468

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional 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
Study First Received: May 10, 2006
Results First Received: January 3, 2013
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
bone loss
osteoporosis

ClinicalTrials.gov processed this record on September 16, 2014