CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 79 enrolled
Drug / intervention
Denosumab +3 morebiological
Likely dose
Denosumab 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00890981
NCT00890981Phase 3Completed
CompareCT.gov

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

Amgen·interventional·Posted Apr 30, 2009·Updated Apr 2, 2014

In Brief

A Phase 3 clinical trial evaluating high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA), and 2 other interventions for Low Bone Mass and 3 related conditions. Completed, enrolled 79 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 30, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.2 years ago

Interventions

high-resolution peripheral quantitative computed tomography (HR-pQCT)procedure

Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.

Dual energy X-ray absorptiometry (DXA)procedure

Bone densitometry assessments of the forearm by DXA on day 1.

Denosumabbiological

Denosumab 60 mg subcutaneously every 6 months in the previous study

Placebodrug

Placebo to denosumab subcutaneously every 6 months in the previous study