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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 9, 2014

Interventions

  • Drug: Romosozumab
    • Administered by subcutaneous injection
  • Drug: Placebo
    • Administered by subcutaneous injection

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
  • Experimental: Romosozumab 70 mg
    • Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
  • Experimental: Romosozumab 140 mg
    • Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
  • Experimental: Romosozumab 210 mg
    • Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
    • Time Frame: 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
    • Time Frame: 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 Total Hip
    • Time Frame: Baseline and 12 months
    • Bone 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
    • Time Frame: 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
    • 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.
  • Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
    • Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
  • Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
    • Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
  • Percent Change From Baseline in Osteocalcin
    • Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
  • Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
    • Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
  • Area Under the Curve Through Month 12 of P1NP
    • Time Frame: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 55 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amgen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • MD, Study Director, Amgen

References

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.

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