Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00890981
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : July 28, 2011
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 30, 2009
Results First Submitted Date  ICMJE June 30, 2011
Results First Posted Date  ICMJE July 28, 2011
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE July 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT [ 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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
The primary endpoint is the percent change from the 20050179 baseline in cortical thickness at the distal radius as determined by HR-pQCT (the baseline was established in the protocol 20050179). [ Time Frame: Day 1 compared to baseline in 20050179 ]
Change History Complete list of historical versions of study NCT00890981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
  • Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
  • HR-pQCT parameters at: the distal radius (total BMD, cortical BMD, trabecular BMD), the tibia (cortical thickness, cortical BMD, total BMD and trabecular BMD) and 1/3 radius, ultradistal radius and total radius BMD as determined by DXA [ Time Frame: Percent Change from baseline in 20050179 to Day 1 ]
  • BTM [Procollagen type 1 amino-terminal propeptide (P1NP) and C-Telopeptide Type 1 (CTX-1)] [ Time Frame: Day 1 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
Official Title  ICMJE A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Low Bone Mass
  • Low Bone Mineral Density
  • Osteoporosis
  • Postmenopausal Osteoporosis
Intervention  ICMJE
  • Procedure: high-resolution peripheral quantitative computed tomography (HR-pQCT)
    Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.
  • Procedure: Dual energy X-ray absorptiometry (DXA)
    Bone densitometry assessments of the forearm by DXA on day 1.
  • Biological: Denosumab
    Denosumab 60 mg subcutaneously every 6 months in the previous study
  • Drug: Placebo
    Placebo to denosumab subcutaneously every 6 months in the previous study
Study Arms  ICMJE Arm 1
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.
Interventions:
  • Procedure: high-resolution peripheral quantitative computed tomography (HR-pQCT)
  • Procedure: Dual energy X-ray absorptiometry (DXA)
  • Biological: Denosumab
  • Drug: Placebo
Publications * concept.747 Treatment/discontinuation on wrist.Journal-004521;

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2010)
79
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2009)
75
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Canada
 
Administrative Information
NCT Number  ICMJE NCT00890981
Other Study ID Numbers  ICMJE 20080747
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP