None listed
Conditions
Brief summary
Osteoporosis is common in the Australian population and is a disease in which the bones lose minerals such as calcium, more quickly than the body can replace them. As a results, the bones become fragile and brittle, leading to higher risk of fractures and a loss of bone mass. Bisphosphonates are the main drugs used in the treatment of osteoporosis and work by inhibiting bone loss. Bisphosphonates also have additional effects that are not related to preventing bone loss. These additional effects are thought to be due to their action on the immune system (the cells that fight against disease in the body). There is no study to date showing that bisphosphonates are taken up by human immune cells and this study will enable us to examine the impact these medications have on the human immune system.
Interventions
Patients who are bisphosphonate naive and have been instructed to start bisphosphonate therapy by their physician will be eligible to be enrolled in this trial. The treatment with either weekly oral bisphosphonate (Alendronate or Risedronate) or single IV bisphosphonate (Zoledronic acid) will be made based on patient preference and best clinical practice, The choice of treatment will be made prior to enrolment in the study and will not be influenced by the study.
The study involves two or three
Patients who are bisphosphonate naive and have been instructed to start bisphosphonate therapy by their physician will be eligible to be enrolled in this trial. The treatment with either weekly oral bisphosphonate (Alendronate or Risedronate) or single IV bisphosphonate (Zoledronic acid) will be made based on patient preference and best clinical practice, The choice of treatment will be made prior to enrolment in the study and will not be influenced by the study. The study involves two or three additional blood tests and visits in addition to the blood tests that occur as part of routine care. Routine care involves baseline bloods completed prior to commencing therapy, and then blood tests at 6 and 12 months. Patients receiving intravenous bisphosphonate therapy will have three additional blood tests (i.e. 1 day, 1 week and 1 month following the intravenous therapy). Patients receiving oral bisphosphonates then you will receive two additional blood tests (1 week and 1 month after starting the oral therapy). The blood samples will then be analysed to test for the presence of bisphosphonate within the myeloid cells of the human immune system.
Sponsors
Bone Research Group, Garvan Institute of Medical Research
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed