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

NCT00890981 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2014-04-02

Study results available
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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.

Conditions

  • Low Bone Mass
  • Low Bone Mineral Density
  • Osteoporosis
  • Postmenopausal Osteoporosis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-06-30
Completion
2010-08-31

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00890981 on ClinicalTrials.gov