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

NCT02435147 | Completed Results

• 1 other identifier: HE 15 03 003
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis; Bone Fracture

Outcome Measures

Primary Outcomes (1)

• Proportion of Change in Mean Trabecular Bone Score

  Proportion of change in mean trabecular bone score at 36 months following denosumab initiation

  Baseline and 36 months

Secondary Outcomes (1)

• Proportion of Change in Mean Femur Strength Index Score

  Baseline and 36 months

Interventions

denosumab DRUG

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

Also known as: Prolia

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll postmenopausal women between the ages of 40 and 90 years who have completed a minimum of 36 months of denosumab therapy for the treatment of osteoporosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthEast Care System: lead
• Amgen: collaborator

Study Sites (1)

HealthEast Care System

Saint Paul, Minnesota, 55104, United States

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This is a small observational study of Caucasian women in a single, Midwest clinical practice. The results cannot be generalized to the broader population.

Results Point of Contact

• Title: Amy Fehrer
• Organization: HealthEast Care System

afehrer@healtheast.org

651-232-5363

Study Officials

• Christine Simonelli, MD

  HealthEast Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trials Office Program Manager

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 6, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)