The Effect of Bisphosphonates on the Immune System in Adults With Osteoporosis

Not Applicable

Recruiting

• Conditions: Osteoporosis; Immune system; Musculoskeletal - Osteoporosis; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12614000300673
• Lead Sponsor: Bone Research Group, Garvan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Sex: male or female
Age range: 20 years of age or older
Disease status: diagnosis of osteoporosis based on either a T-score of less than or equal to -2.5 SD on bone densitometry or minimal trauma fracture.
Must meet the PBS authority criteria for bisphosphonate therapy.
Concomitant disease status: immunocompetent
Laboratory parameters: eGFR equal to or more than 30
Willingness to give written or informed consent and willingness to participate to and comply with the study.

Exclusion Criteria

Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
Laboratory parameters: eGFR < 30
Patients who have received previous anti-resorptive therapy.
Patients with dental issues requiring extraction or intervention involving the jaw bone.
Patients unable to give informed consent.
Patients receiving medication that may interact with either prenylation or the immune system: statin therapy and immunosuppressant therapy including glucocorticoids

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether bisphosphonates are internalized by circulating myeloid cells and inhibit protein prenylation, thereby altering immune cell function.<br>The inhibition of protein prenylation will be detected by performing a Western Blot on purified myeloid cells from the blood samples.<br><br>[12 months]

Secondary Outcome Measures

Name	Time	Method
To determine how long the effect on myeloid cells can be detected for (ie time of onset and offset of the effect), after single intravenous or continuous oral administration.<br>This will be assessed by performing Western Blots on the purified blood samples from baseline to 12 months and then determining the duration of inhibition of protein prenylation.[12 months]