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OpenTrials
Completed

NCT Number: NCT00325468

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

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

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Key information

Conditions

Low Bone Mineral Density Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMG 162

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
May 12, 2006
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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