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Study Complete
Sponsor ID
20101291

Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

Sponsor ID
20101291
Clinicaltrials.gov ID
NCT01992159
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 2
Product
AMG 785
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
252
Additional Study Details

Protocol Summary

Primary Outcome Measures

• Change in Bone Mineral Density at the lumbar spine from Baseline to 12 Months

Timeframe: 12 months

Secondary Outcome Measures

• Change in Bone Mineral Density at the lumbar spine from Baseline to Month 6

Timeframe: 6 months

• Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 6

Timeframe: 6 months

• Change in Bone Mineral Density at the total hip and femoral neck from Baseline to Month 12

Timeframe: 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

Timeframe: 12 months

• Analysis of the P1NP bone marker through Month 12

Timeframe: 12 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Anjyo-shi, Aichi, Japan, 446-0063
Status
Recruiting
Location
Research Site
Fukuoka-shi, Fukuoka, Japan, 814-0165
Status
Recruiting
Location
Research Site
Hachioji-shi, Tokyo, Japan, 192-0046
Status
Recruiting
Location
Research Site
Kita-adachi-gun, Saitama, Japan, 362-0806
Status
Recruiting
Location
Research Site
Kitakyushu-shi, Fukuoka, Japan, 800-0057
Status
Recruiting
Location
Research Site
Kiyose-shi, Tokyo, Japan, 204-0021
Status
Recruiting
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Study Info
Age
55 - 85 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Oct 2012 - Oct 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)
    Exclusion Criteria:
    • Severe osteoporosis • Use of agents affecting bone metabolism • History of metabolic or bone disease (except osteoporosis) • Vitamin D insufficiency (vitamin D repletion and rescreening is permitted) • Current hyper- or hypocalcemia • Current, uncontrolled hyper- or hypothyroidism • Current, uncontrolled hyper- or hypoparathyroidism