Osteoporosis studies

Distinguished Professor Ian Reid - Principal Investigator

Dr Anne Horne - Co-Investigator 

Angela Stewart - Study Coordinator

This study is a prospective, randomised, placebo-controlled, double-blind trial to be carried out over a period of 6 years. Two thousand osteopenic postmenopausal women consenting to participate and meeting the inclusion/exclusion criteria have been randomly assigned to receive infusions of either zoledronic acid 5 mg or normal saline every 18 months. The primary end-point is osteoporotic fracture which will be monitored at visits. Bone density and vertebral x-rays will be assessed at baseline, 3 years and 6 years.

Recruitment is complete for this study.

Please feel free to contact the researchers if you have any questions about this study.

The main paper describing this study has now been published by the New England Journal of Medicine. Please click here to read the paper. 

Bone and Joint Research Group
University of Auckland
Auckland Hospital
Private Bag 92024
Auckland

Dr Anne Horne
Phone: +64 9 923 9787
Email: a.horne@auckland.ac.nz

Leanne Purvis - Appointments
Phone: +64 9 923 8607
Email: leanne.purvis@auckland.ac.nz

Angela Stewart
Phone: +64 9 923 9788
Email: angela.stewart@auckland.ac.nz

Associate Professor Mark Bolland - Principal Investigator

Anna Mellar - Study coordinator

Fractures are a major health problem, occurring in >50% of older women. Low bone density is a strong risk factor for fracture, but 80% of fractures occur in women without low bone density. We have fully recruited a 10 year clinical trial in 1054 women investigating whether zoledronate, an effective treatment for osteoporosis, can be given very infrequently by injection to prevent bone loss and spinal fractures in early post-menopausal women with normal or only mildly low bone density.

The first participants completed 3 years of follow-up in June 2015. During the trial, zoledronate or an inactive agent (placebo) is administered every 5 years. The main outcomes are occurrence of new spinal fractures and changes in bone density. If the treatment is effective, the study will offer a new, more convenient approach to preventing fractures, and potentially a much higher proportion of fractures could be avoided than with current strategies.

Recruitment is complete for this study.

Please feel free to contact the researchers if you have any questions about this study.

Bone & Joint Research Group 
University of Auckland 
Auckland Hospital 
Private Bag 92 024 
Auckland 

Anna Mellar
Phone: +64 9 923 9785
Email: anna.mellar@auckland.ac.nz

Professor Nicola Dalbeth - Principal Investigator

Bobby Mihov - Study Coordinator

Angela Stewart - Study Coordinator

Low bone density or thinning of bones (known as osteoporosis) is a major problem later in life, resulting in fractures in one half of older women. Currently, there are very few treatments recommended to prevent fractures, especially in women with only mildly low bone density. We wish to test whether inosine, which is available as an ‘over the counter’ supplement, might have beneficial effects on markers of bone health. If inosine supplements have significant effects on markers of bone health, they might also improve bone density and prevent fractures.

Studies in the general population have shown that high blood urate levels might improve bone health. Inosine is a supplement that increases blood urate levels.  This study will systematically assess the effect of inosine supplements available in New Zealand on markers of bone health. Women over the age of 55 years will be selected randomly (i.e. by chance) to receive inosine supplements or a placebo (inactive treatment). 

Recruitment is complete for this study.

Please feel free to contact the researchers if you have any questions about this study.

Bone & Joint Research Group 
University of Auckland 
Auckland Hospital 
Private Bag 92 024 
Auckland 

Bobby Mihov
Phone: +64 9 923 4100
Email: b.mihov@auckland.ac.nz

Angela Stewart
Phone: +64 9 923 9788
Email: angela.stewart@auckland.ac.nz

Associate Professor Mark Bolland - Principal Investigator

Veronica Pinel - Study coordinator

Fractures occur in >50% of older women. Low bone density is a strong risk factor for fracture, but 80% of fractures occur in women with only mildly low bone density. Currently, there are no acceptable evidenced-based treatments for these women. Small studies have suggested that organic nitrates, which are commonly used to treat heart disease, might increase bone density. We plan to systematically investigate their effects on bone density.

We will undertake a 2-year randomised, placebo-controlled trial of 5 different doses of organic nitrates in post-menopausal women with mildly low bone density. Participants will receive organic nitrates or inactive treatment for 1 year and then will be followed without treatment for 1 year. The main outcome is the change in bone density. If the treatment is effective, the study will provide the evidence base for a large trial to be conducted to test whether these agents can prevent fractures.

Recruitment is complete for this study.

Please feel free to contact the researchers if you have any questions about this study.

Bone & Joint Research Group 
University of Auckland 
Auckland Hospital 
Private Bag 92024 
Auckland 

Veronica Pinel
Phone: +64 9 923 9785
Email: v.pinel@auckland.ac.nz

Associate Professor Andrew Grey - Principal Investigator

Bobby Mihov - Study Coordinator

This 2-year study aims to determine whether low doses of zoledronate, an effective treatment for osteoporosis, produce similar effects on bone health to those that occur in response to the current, standard dose. 180 postmenopausal women with thin bones (osteopenia) were randomly (by chance) allocated to receive either placebo (inactive) treatment, or one of 3 doses of zoledronate, 1mg, 2.5mg or 5mg, given as a single infusion into a vein (by “drip”). Participants had measurements of bone density and blood markers of bone metabolism before receiving the study treatment, and then on 8 (markers of bone metabolism) or 4 (bone density) occasions over the following two years.

Recruitment is complete for this study, which has now entered it's second extension.

• First extension

We conducted a 2-year extension of this study because of recent evidence showing that the antiresorptive effects of zoledronate persist for longer than previously recognised.

These parts of the study are finished. The study has now entered a second extension.

• Second extension

The reason for doing a further extension study is that results from another study of zoledronate shows that the effects on bone of the usual dose (5mg) last for at least 5 years, and we know little about the effects of zoledronate beyond 3-5 years. The aim of the trial extension is to study the effects over 10 years on bone of doses of zoledronate of 1mg, 2.5mg and 5mg. The study has already shown that the effects of the lower doses of zoledronate (1mg and 2.5mg) last at least 3 years. We think it important to find out how long the effects of each dose lasts, and whether re-treatment with the low doses produces beneficial effects on bone over a 10 year period, since many people with osteoporosis are recommended to take medication for at least that long.

Please feel free to contact the researchers if you have any questions about this study.

Bone & Joint Research Group 
University of Auckland 
Auckland Hospital 
Private Bag 92 024 
Auckland 

Bobby Mihov
Phone: +64 9 923 4100
Email: b.mihov@auckland.ac.nz

Dr Sarah Bristow & Distinguished Professor Ian Reid - Co-investigators

Calcium supplements are widely used by people around the world to improve bone health; however, recent evidence suggests that long-term use of these calcium supplements may increase the risk of heart attacks. Hydroxyapatite may provide a safe form of calcium supplementation. Before hydroxyapatite can be widely recommended, we must first test whether it is as effective as standard calcium supplements in reducing bone loss and examine its effects on blood coagulation and indices of heart disease. This study will compare three different hydroxyapatite preparations and calcium citrate with respect to these changes.

This study involves use of one of three hydroxyapatite preparations, calcium citrate or a placebo for 3 months, and involves a total of two visits to our research clinic. On the first visit you will be asked to remain at the clinic for 8 hours for blood sampling and blood pressure measurement.

Recruitment is complete for this study.

Please feel free to contact the researchers if you have any questions about this study.

Bone & Joint Research Group 
University of Auckland 
Auckland Hospital 
Private Bag 92024 
Auckland 

Sarah Bristow 
Phone: +64 9 923 8607
Email: s.bristow@auckland.ac.nz

Distinguished Professor Ian Reid, Dr Anne Horne & Dr Emma Billington - Co-investigators

Zoledronic acid is a medication commonly used in the treatment of osteoporosis and other bone diseases. Some people develop an inflammatory reaction following treatment with zoledronic acid, called an acute phase response. Glucocorticoid medications such as dexamethasone have anti-inflammatory effects, and these medications are currently used to treat several inflammatory conditions. It is hypothesised that a dose of dexamethasone, given at the time of zoledronic acid infusion, will reduce the likelihood of developing an acute phase response.

In this study, forty adults who require treatment with zoledronic acid will be randomized to receive oral dexamethasone (4mg) or placebo at the time of treatment. Oral temperature and inflammatory symptoms will be assessed at baseline, and reassessed at regular intervals for three days following the treatment. Inflammatory symptoms will be assessed once again 15 days following the treatment. Change in temperature and change in inflammatory symptoms will be compared in persons who receive dexamethasone and persons who receive placebo.

Recruitment is complete for this study.

Please feel free to contact the researchers if you have any questions about this study.

Bone & Joint Research Group 
University of Auckland 
Auckland Hospital 
Private Bag 92 024 
Auckland 

Dr Anne Horne
Phone: +64 9 923 9787
Email: a.horne@auckland.ac.nz

Dr Dorit Naot - Principal Investigator         

This is a collaborative study between the clinical group and the bone laboratory looking at age-related changes in gene expression in human bone cells, and relating these changes to bone microarchitecture. Elucidation of age-related molecular changes in human bone cells could potentially contribute to the discovery of novel drug targets for the prevention and treatment of age-related osteoporosis and fracture.

Participant recruitment and sample collection
Patients scheduled to undergo hip joint replacement for osteoarthritis will be recruited by our collaborating surgeons, led by Mr Jacob Munro and Associate Professor Rocco Pitto. Those with metabolic bone disease or using bone-active drugs will be excluded. We will recruit two groups of 30 patients: those <60 years of age, and those >70 years. Participants will attend a single study visit prior to their surgery.

Recruitment is complete for this study.

Please feel free to contact the researchers if you have any questions about this study.

Bone & Joint Research Group 
University of Auckland 
Auckland Hospital 
Private Bag 92 024 
Auckland 

Dr Anne Horne
Phone: +64 9 923 9787
Email: a.horne@auckland.ac.nz