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Study Complete
Sponsor ID
20080747

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

Sponsor ID
20080747
Clinicaltrials.gov ID
NCT00890981
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
79
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent change from the parent study baseline in cortical thickness at the distal radius by HR-pQCT

Timeframe: Day 1

Secondary Outcome Measures

Percent change from the parent study baseline in total BMD at the distal radius by HR-pQCT

Timeframe: Day 1

Percent change from the parent study baseline in cortical BMD at the distal radius by HR-pQCT

Timeframe: Day 1

Percent change from the parent study baseline in trabecular BMD at the distal radius by HR-pQCT

Timeframe: Day 1

Percent change from the parent study baseline in cortical thickness at the distal tibia by HR-pQCT

Timeframe: Day 1

Percent change from the parent study baseline in total BMD at the distal tibia by HR-pQCT

Timeframe: Day 1

Percent change from the parent study baseline in cortical BMD at the distal tibia by HR-pQCT

Timeframe: Day 1

Percent change from the parent study baseline in trabecular BMD at the distal tibia by HR-pQCT

Timeframe: Day 1

Percent change of distal 1/3 radius BMD from the parent study baseline by DXA

Timeframe: Day 1

Percent change of ultradistal radius BMD from the parent study baseline by DXA

Timeframe: Day 1

Percent change of total radius BMD from the parent study baseline by DXA

Timeframe: Day 1

Actual Value of Serum Type I C-telopeptide

Timeframe: Day 1

Actual Value of Procollagen Type 1 N-terminal Peptide

Timeframe: Day 1

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
N/A
Condition
  • Osteoporosis
    • Show more
  • Bone Loss
    • Sex
    Assigned Female at Birth
    Trial Dates
    Jul 2009 - Jun 2010
    Inclusion and Exclusion 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).