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An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

NCT01796301 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2022-11-29

Study results available
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Summary

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Romozosumab

Administered by subcutaneous injection once a month.

DRUG

Teriparatide

Administered by subcutaneous injection once a day.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-05-14
Completion
2015-05-14

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Hungary
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT01796301 on ClinicalTrials.gov