Skip to main content
OpenTrials
Completed

NCT Number: NCT01992159

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopausal Osteoporosis (PMO) Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Anjyo-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Romosozumab

Drug

Administered by subcutaneous injection

Other names: AMG 785, EVENITY™

Placebo

Drug

Administered by subcutaneous injection

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. Percent Change From Baseline in Osteocalcin

    Time frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12

  9. Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)

    Time frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12

  10. Area Under the Curve Through Month 12 of P1NP

    Time frame: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.