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Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index

NCT02435147 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2018-10-29

Study results available
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Summary

The purpose of this study is to validate the long-term benefit of denosumab for osteoporosis treatment in a real-world clinical practice setting. We hypothesize that continued therapy (36+months) with denosumab will increase both trabecular bone score (TBS) and femur strength index (FSI) and reduce fracture and other bone health risks among post-menopausal women with osteoporosis.

Conditions

Interventions

DRUG

denosumab

Patients will receive denosumab 60 mg subcutaneously every six months as part of their standard osteoporosis treatment.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • HealthEast Care System

    lead OTHER

Principal Investigators

  • Christine Simonelli, MD · HealthEast Care System

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT02435147 on ClinicalTrials.gov