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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthEast Care System
• Collaborator: Amgen
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Subjects must meet the following inclusion criteria to be eligible for study entry:

• Post-menopausal female with diagnosed osteoporosis

• Age 40-90 years

• Completed 36 months of denosumab therapy (SQ; 60mg every 6 months) but not yet received the 42 month injection

• Availability of DXA scans at the study-required time points, including the willingness of subjects to undergo a DXA evaluation at 36 months, if required

• Provided written informed consent

Exclusion Criteria:

• Patients will be excluded from this study for any of the following reasons:

• Received denosumab injections for less than 36 months

• Patients who have missed more than 1 dose of denosumab in a 36 month period

• Contra-indicated for treatment with denosumab

• History of rheumatoid arthritis

• Current diagnosis of hyperparathyroidism; hyperthyroidism; osteomalacia, or other known diseases that can affect bone

• In the opinion of the investigator, have any kind of disorder that may compromise the ability of the subject to provide written informed consent