Clinical Trials Logo
  1. Home
  2. Low Bone Mineral Density
  3. NCT00043186

Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Low Bone Mineral Density Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00043186
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 2
Start date May 2002
Completion date June 2007
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05902078 - Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis Phase 4
Completed NCT00980174 - Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis Phase 3
Completed NCT00089661 - AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer Phase 3
Completed NCT00925600 - A Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy Phase 3
Completed NCT00515463 - A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density Phase 3
Completed NCT00325468 - An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density Phase 3
Completed NCT00896532 - Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density Phase 2
Completed NCT00887965 - A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab Phase 2
Completed NCT00890981 - A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab Phase 3
Completed NCT01215890 - Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease Phase 4