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A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

Primary Purpose

Low Bone Mass, Low Bone Mineral Density, Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
high-resolution peripheral quantitative computed tomography (HR-pQCT)
Dual energy X-ray absorptiometry (DXA)
Denosumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Bone Mass

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ambulatory, postmenopausal women
  • Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Arm 1

    Arm Description

    Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.

    Outcomes

    Primary Outcome Measures

    Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
    Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

    Secondary Outcome Measures

    Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT
    Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the 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
    Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the 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
    Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months 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
    Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the 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
    Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months 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
    Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the 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
    Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the 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
    Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.
    Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA
    Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.
    Percent Change of Total Radius BMD From the Parent Study Baseline by DXA
    Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Actual Value of Serum Type I C-telopeptide
    Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).
    Actual Value of Procollagen Type 1 N-terminal Peptide
    Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).

    Full Information

    First Posted
    April 23, 2009
    Last Updated
    March 5, 2014
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00890981
    Brief Title
    A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
    Official Title
    A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    79 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Other
    Arm Description
    Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
    Intervention Type
    Procedure
    Intervention Name(s)
    high-resolution peripheral quantitative computed tomography (HR-pQCT)
    Intervention Description
    Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dual energy X-ray absorptiometry (DXA)
    Intervention Description
    Bone densitometry assessments of the forearm by DXA on day 1.
    Intervention Type
    Biological
    Intervention Name(s)
    Denosumab
    Intervention Description
    Denosumab 60 mg subcutaneously every 6 months in the previous study
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to denosumab subcutaneously every 6 months in the previous study
    Primary Outcome Measure Information:
    Title
    Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Secondary Outcome Measure Information:
    Title
    Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT
    Description
    Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA
    Description
    Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA
    Description
    Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Percent Change of Total Radius BMD From the Parent Study Baseline by DXA
    Description
    Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
    Time Frame
    Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
    Title
    Actual Value of Serum Type I C-telopeptide
    Description
    Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).
    Time Frame
    Day 1
    Title
    Actual Value of Procollagen Type 1 N-terminal Peptide
    Description
    Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).
    Time Frame
    Day 1

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ambulatory, postmenopausal women Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    concept.747 Treatment/discontinuation on wrist.Journal-004521;
    Results Reference
    background
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

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