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

Phase 2

Completed

Conditions: Postmenopausal Osteoporosis (PMO)

Interventions: Drug: Placebo
Drug: Romosozumab

Registration Number: NCT01992159

Lead Sponsor: Amgen

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 252

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab 210 mg	Romosozumab	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab 70 mg	Romosozumab	Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab 140 mg	Romosozumab	Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine	Baseline and 12 months	Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)	Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Osteocalcin	Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine	Baseline and 6 months	Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip	Baseline and 6 months	Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck	Baseline and 6 months	Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck	Baseline and 12 months	Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)	Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)	Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip	Baseline and 12 months	Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
Area Under the Curve Through Month 12 of P1NP	Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.