NCT02014467

Denosumab China Phase III Study

A Twelve-Month Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Denosumab in Chinese Postmenopausal Women With Osteoporosis at Increased Risk of Fracture

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.

Detailed description

The aim of this Phase III, randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of denosumab (DMAb) in Chinese postmenopausal women with osteoporosis at increased risk of fracture. The study design consists of two phases: Screening and 12-month Double-Blind treatment phase. Following the Screening phase, all eligible subjects will be randomized to receive Double-Blind DMAb (60 mg) or Placebo study medication in a 3:1 ratio. DMAb 60 mg and placebo will be administered as a single subcutaneous (SC) injection at the beginning of the Double-Blind phase and at 6 months following the initial dose. All subjects will receive daily supplementation of oral elemental calcium (at least 600 mg) and vitamin D (at least 400 International Units \[IU\]). The primary objective is to determine the effects of DMAb compared to placebo with respect to mean percent change in BMD at the lumbar spine, as measured by dual-energy x-ray absorptiometry (DXA), from Baseline to Month 12. Secondary objectives include the evaluation between the DMAb and placebo treatment groups: change in BMD: at the lumbar spine (Month 6), total hip (Months 6 and 12), femoral neck (Months 6 and 12) and trochanter (Months 6 and 12); and serum biomarkers of bone formation and resorption (Months 6 and 12). Clinical safety of denosumab will also be assessed in this population.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Denosumab	Injection
DRUG	Placebo	Injection
DIETARY_SUPPLEMENT	Elemental Calcium	Oral, at least 600 mg
DIETARY_SUPPLEMENT	Vitamin D	Oral, at least 400 IU

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-12-18
• Last updated: 2016-10-31
• Results posted: 2016-10-31

Locations

8 sites across 1 country: China