NCT01992159 - Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis | Crick | Crick

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

Phase 2CompletedNCT01992159

Amgen252 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

252

Conditions

Postmenopausal Osteoporosis (PMO)

Interventions

RomosozumabDRUG

Administered by subcutaneous injection

Administered by subcutaneous injection

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (27)

Research Site

Anjyo-shi, Aichi-ken, Japan

Outcomes

Primary Outcomes

Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine

Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

Time frame: Baseline and 12 months

Secondary Outcomes

Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine

Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

Time frame: Baseline and 6 months

Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip

Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

Time frame: Baseline and 6 months

Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip

Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

Time frame: Baseline and 12 months

Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck

Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

Time frame: Baseline and 6 months

Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck

Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

Time frame: Baseline and 12 months

Data from ClinicalTrials.gov

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