The effect of zoledronate on marrow fat in osteoporotic elderly patients who have suffered a minimal trauma fracture.

A double blind randomised controlled trial assessing the effect of zoledronate on marrow fat in older osteoporotic persons after suffering a minimal trauma fracture

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000082909

Acronym

FAT

Enrollment

Registered

2011-01-21

Start date

2013-02-02

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 marrow fat in patients who have suffered a minimal trauma fracture. Changes in marrow fat in femur and vertebrae will be quantified using CT and MRI images analised using an image analysis software (Tomovision).

Interventions

Intravenous zoledronic acid (5mg) infused over 30 minutes on one occasion only.

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- History of minimal trauma fracture within 90 days before starting the trial 2- Age: Older than 65 3- Female

Exclusion criteria

1) Patients taking statins for cholesterol lowering 2) Previous history of diabetes mellitus 3) creatinine clearance < 35 ml/min 4) pre-existing hypocalcemia must be treated by adequate intake of calcium and vitamin D before therapy with zoledronic acid 5) active history of uveitis, iritis, or episcleritis 6) metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing 7) Active primary hyperparathyroidism 8) Hypothyroidism, not appropriately controlled with long-term thyroxine therapy 9) Serum 25-hydroxyvitamin D concentrations <15 ng/L

Outcome results