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Clinical Trial Details

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

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Trial Information

Broad Health Condition Musculoskeletal
Inflammatory and Immune System

Specific Health ConditionOsteoporosis
Other inflammatory or immune system disorders

Trial Focus

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst


Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment12/03/2014

Anticipated date of last participant enrolment12/03/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial 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.
Eligibility

Key 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.

Minimum age20 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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
Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Bone Research Group, Garvan Institute of Medical Research
Primary Sponsor Address: 384 Victoria St Darlinghurst NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12614000300673

UTNU1111-1154-4303

Contact person for information and recruitmentDr
Chelsea McMahon
Level 5, Garvan Institute 384 Victoria St Darlinghurst NSW 2010
+61 (02) 9295 8106

Further information iconchelmcmahon@gmail.com
Australia