Clinical trial NCT01992159: Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Osteoporosis (PMO)
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 252
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
timeFrame: Baseline and 6 months
measure: Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip
timeFrame: Baseline and 6 months
measure: Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck
timeFrame: Baseline and 6 months
measure: Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
timeFrame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
measure: Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
timeFrame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
measure: Percent Change From Baseline in Osteocalcin
timeFrame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
measure: Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
timeFrame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
measure: Area Under the Curve Through Month 12 of P1NP
timeFrame: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.
Other outcomes:
Locations:
city: Anjyo-shi
country: Japan
facility: Research Site
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Yanagawa-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Mizunami-shi
country: Japan
facility: Research Site
state: Gifu
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Morioka-shi
country: Japan
facility: Research Site
state: Iwate
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Saito-shi
country: Japan
facility: Research Site
state: Miyazaki
city: Matsumoto-shi
country: Japan
facility: Research Site
state: Nagano
city: Ueda-shi
country: Japan
facility: Research Site
state: Nagano
city: Ueda-shi
country: Japan
facility: Research Site
state: Nagano
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Research Site
state: Osaka
city: Kita-adachi-gun
country: Japan
facility: Research Site
state: Saitama
city: Hachioji-shi
country: Japan
facility: Research Site
state: Tokyo
city: Kiyose-shi
country: Japan
facility: Research Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Research Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Research Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokyo
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone. 2017 Oct;103:209-215. doi: 10.1016/j.bone.2017.07.005. Epub 2017 Jul 5.