The effect of zoledronate on cardiovascular protection in osteoporotic elderly patients who have suffered a hip fracture.

A randomised, double-blind, placebo-controlled trial to determine the effect of zoledronate on endothelial dysfunction in osteoporotic elderly patients who have suffered a hip fracture

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000278235

Acronym

ZED

Enrollment

Registered

2009-05-15

Start date

2009-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a one year study to identify the effect of Zoledronate on endothelial dysfunction, a marker or cardiovascular risk.

Interventions

Zoledronic acid 5 mg in 100 mL, intravenous, infused over 30 minutes, single dose.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

65 Years to 100 Years

Healthy volunteers

Inclusion criteria

1- Diagnosis of osteoporosis based on bone mineral density (BMD) 2- Previous history of hip fracture a year prior to the administration of the dose

Exclusion criteria

1) creatinine clearance < 35 ml/min 2) pre-existing hypocalcemia must be treated by adequate intake of calcium and vitamin D before therapy with zoledronic acid 3) active history of uveitis, iritis, or episcleritis 4) metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing 5) History of diabetes mellitus 6) Active primary hyperparathyroidism 7) Hypothyroidism, not appropriately controlled with long-term thyroxine therapy 8) Serum 25-hydroxyvitamin D concentrations <15 ng/L

Outcome results