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A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00890981
First received: April 23, 2009
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Subjects randomized to either denosumab or placebo in the 20050179 study who completed that study (ie, the subject attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the subject's 20050179 end of study visit


Condition Intervention Phase
Low Bone Mass
Low Bone Mineral Density
Osteoporosis
Postmenopausal Osteoporosis
 Procedure: HR-pQCT, DXA and BTM measurements
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab

Resource links provided by NLM:

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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in cortical thickness at the distal radius as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179


Secondary Outcome Measures:
  • Percent Change From the Parent Study Baseline in Total BMD at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in total BMD at the distal radius as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179

  • Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in cortical BMD at the distal radius as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in trabecular BMD at the distal radius as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in cortical thickness at the distal tibia as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in total BMD at the distal tibia as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in cortical BMD at the distal tibia as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change from the 20050179 baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change of distal 1/3 radius BMD from the 20050179 baseline as determined by DXA at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change of ultradistal radius BMD from the 20050179 baseline as determined by DXA at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Percent Change of Total Radius BMD From the Parent Study Baseline by DXA [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Percent change of total radius BMD from the 20050179 baseline as determined by DXA at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179.

  • Actual Value of Serum Type I C-telopeptide [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Actual value at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179

  • Actual Value of Procollagen Type 1 N-terminal Peptide [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Actual value at Month 32 (close to mean and median) since last subcutaneous dose of denosumab or placebo in study 20050179


Enrollment: 79
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Procedure: HR-pQCT, DXA and BTM measurements
Subjects who sign the informed consent will undergo HR-pQCT and DXA measurements. The study will consist of one visit for screening, enrollment and completion of study procedures (DXA, HR-pQCT and BTM). No study drug will be administered during the course of the study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory, postmenopausal women
  • Randomized to either denosumab or placebo in the 20050179 study and completed that study (ie, the subject attended an end of study visit)
  • At least 12 months have elapsed since their end of 20050179 study visit
  • Provide signed informed consent

Exclusion Criteria:

  • Subjects who failed to receive both doses of denosumab (or SQ [subcutaneous] placebo) during the 20050179 study
  • Subjects who were randomized to the alendronate arm during the 20050179 study
  • Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
  • Hyperthyroidism
  • Hyperparathyroidism
  • Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
  • Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
  • Other diseases which affect bone metabolism
  • Self-reported alcohol or drug abuse within the previous 12 months
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
  • Received any investigational product other than denosumab in two years before the screening visit.
  • Received > 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
  • Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
  • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890981

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

Additional Information:
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00890981     History of Changes
Other Study ID Numbers: 20080747
Study First Received: April 23, 2009
Results First Received: June 30, 2011
Last Updated: June 30, 2011
Health Authority: Argentina: Ministry of Health
Canada: Health Canada
United States: Food and Drug Administration
Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013