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Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

NCT00896532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2022-09-22

Study results available
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Summary

The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.

Conditions

  • Low Bone Mineral Density
  • Postmenopausal Osteoporosis

Interventions

DRUG

Placebo to Romosozumab

Administered by subcutaneous injection QM or Q3M.

DRUG

Alendronate

Administered orally once a week

DRUG

Teriparatide

Teriparatide 20 μg administered by subcutaneous injection once a day

DRUG

Romosozumab

Administered by subcutaneous injection

DRUG

Denosumab

Denosumab 60 mg administered by subcutaneous injection Q6M

DRUG

Placebo to Denosumab

Administered by subcutaneous injection Q6M

DRUG

Zoledronic acid

Zoledronic acid 5 mg administered intravenously

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-03
Primary Completion
2011-02-21
Completion
2016-02-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00896532 on ClinicalTrials.gov