CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
AMG 162drug
Likely dose
Denosumab 60 mg IV every 6 monthsAI-extracted
Key inclusion· 2
  • ✓Must be ambulatory
  • ✓Must have completed the prior 20010223 phase 3 end-of-study visit with all tests and procedures
Key exclusion· 4
  • ✕Experienced severe or serious adverse event related to denosumab in prior study
  • ✕Developed grade 3 or 4 laboratory abnormalities during prior study that did not normalize or lacked diagnosis/treatment
  • ✕Newly diagnosed conditions including hyper/hypothyroidism, rheumatoid arthritis, bone disease, or renal disease
  • ✕Use of bone-active medications during prior study: oral bisphosphonates, calcitonin, oral strontium, SERMs, or systemic glucocorticoids

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

Search/NCT00325468
NCT00325468Phase 3Completed
CompareCT.gov

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

Amgen·interventional·Posted May 12, 2006·Updated Aug 1, 2017

In Brief

A Phase 3 clinical trial evaluating AMG 162 for Low Bone Mineral Density. Completed, enrolled 200 participants.

Detailed Summary

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Bone Mineral Density
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2006
Enrollment StartMay 1, 2006
Primary CompletionMar 28, 2011
Study CompletionAug 2, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.1 years ago

Interventions

AMG 162drug

AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42