CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 412 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Denosumab for subcutaneous injection (specific dose not stated in published record); Alendronate 70 mg tabletsAI-extracted
Key inclusion· 5
  • ✓Postmenopausal women ≤80 years of age at randomization
  • ✓At least 1 year postmenopausal at randomization
  • ✓Ambulatory
  • ✓Low BMD with T-score ≤-1.8 at lumbar spine, femoral neck, or total hip (but not <-4.0 at lumbar spine or <-3.5 at femoral neck/total hip)
Key exclusion· 18
  • ✕Bisphosphonate use within 12 months before enrollment
  • ✕Fluoride treatment for osteoporosis within 2 years before enrollment
  • ✕Systemic hormone replacement therapy within 3 months before enrollment
  • ✕Parathyroid hormone (PTH) or derivative within 6 months before enrollment

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

Search/NCT00043186
NCT00043186Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Amgen·interventional·Posted Aug 7, 2002·Updated Sep 18, 2013

In Brief

A Phase 2 clinical trial evaluating Placebo, Denosumab, and 1 other intervention for Low Bone Mineral Density. Completed, enrolled 412 participants.

Detailed Summary

To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2002
Enrollment StartMay 1, 2002
Primary CompletionApr 1, 2007
Study CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 23.9 years ago

Interventions

Placebodrug

Placebo subcutaneous injection

Denosumabdrug

Denosumab for subcutaneous injection

Alendronatedrug

Alendronate 70 mg tablets