None listed
Conditions
Brief summary
This 2-year study aims to determine whether low doses of zoledronate produce similar effects on bone health to those that occur in response to the current, standard dose. 180 postmenopausal women with thin bones (osteopenia) will be 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 will have measurement 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 2 years
Interventions
At the end of the original double blind 2 year protocol, all participants were invited to participate in a 2 year open-label extension, during which no further study drug was administered to any participants.
4 years after administration of the baseline dose, all participants still in follow-up were invited to enter a second open-label extension. In the first year of this extension, no further study drug was administered. At 5 years, those who received 1mg or 2.5mg zoledornic acid were adminis
At the end of the original double blind 2 year protocol, all participants were invited to participate in a 2 year open-label extension, during which no further study drug was administered to any participants. 4 years after administration of the baseline dose, all participants still in follow-up were invited to enter a second open-label extension. In the first year of this extension, no further study drug was administered. At 5 years, those who received 1mg or 2.5mg zoledornic acid were administered a second single identical dose. Participants who received placebo or 5mg zoledronic acid at baseline did not receive further study drug. Follow-up is planned until 10 years after the baseline dose of study drug.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
Inclusion criteria
Postmenopausal women Bone density T Score < -1 and > -2.5 at lumbar spine or total hip
Exclusion criteria
kidney, liver, thyroid or parathyroid dysfunction current cancer osteoporosis vitamin D deficiency medications known to influence bone metabolism
Outcome results
None listed