Clinical Trial: Study With AMG 785 to Treat Japanese Women With Postmenopausal Osteoporosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Japanese Women With Post

Brief Summary: The purpose of this study is to determine if the treatment increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome: • Change in Bone Mineral Density at the lumbar spine from Baseline to 12 Months [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • • Change in Bone Mineral Density at the lumbar spine from Baseline to Month 6 [ Time Frame: 6 months ]
  • • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 6 [ Time Frame: 6 months ]
  • • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 12 [ Time Frame: 12 months ]
  • • Change in bone markers from baseline at Day 1 plus 1 week, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 [ Time Frame: 12 months ]
  • • Analysis of the P1NP bone marker through Month 12 [ Time Frame: 12 months ]


Original Secondary Outcome:

  • • Change in Bone Mineral Density at the lumbar spine from Baseline to Month 6 [ Time Frame: 6 months ]
  • • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 6 [ Time Frame: 6 months ]
  • • Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 12 [ Time Frame: 12 months ]
  • • Change in bone markers from baseline at Day 1 plus 1 week, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 [ Time Frame: 12 months ]
  • • Analysis of one bone marker through Month 12 [ Time Frame: 12 months ]


Information By: Amgen

Dates:
Date Received: November 19, 2013
Date Started: October 2012
Date Completion:
Last Updated: September 11, 2015
Last Verified: September 2015