The effect of zoledronate on marrow fat in osteoporotic elderly patients who have suffered a minimal trauma fracture.
Phase 4
Withdrawn
- Conditions
- OsteoporosisMusculoskeletal - OsteoporosisInjuries and Accidents - Fractures
- Registration Number
- ACTRN12611000082909
- Lead Sponsor
- SWAHS - Clinical Governance Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Female
- Target Recruitment
- 60
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/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in marrow fat in femur and vertebrae will be quantified using CT and MRI images analysed using an image analysis software (Tomovision).[6 months and 18 months post-infusion]
- Secondary Outcome Measures
Name Time Method The incidence of fractures will be assessed by requesting the patients to report any minimal trauma fracture. Once the patient has contacted our Research Officer, documentation of the fracture by X-ray (films or report) will be required.[6 months and 18 months post-infusion];Changes in bone mineral density measure by dual energy X-ray absorptiometry (DXA) scan[18 months post- infusion]