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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Postmenopausal Osteoporosis (PMO)
- Sponsor
- Amgen
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.
Investigators
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
Arms & Interventions
Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Intervention: Placebo
Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Intervention: Romosozumab
Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Intervention: Romosozumab
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Intervention: Romosozumab
Outcomes
Primary Outcomes
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
Time Frame: 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 Outcomes
- Percent Change From Baseline in Osteocalcin(Baseline, week 1, and months 1, 2, 3, 6, 9, and 12)
- 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 at 6 Months in Bone Mineral Density at the Lumbar Spine(Baseline and 6 months)
- Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip(Baseline and 6 months)
- Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck(Baseline and 6 months)
- Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck(Baseline and 12 months)
- 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)
- Area Under the Curve Through Month 12 of P1NP(Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.)