The Duration of Action of Zoledronate study
- Conditions
- Post menopausal OsteopeniaReproductive Health and Childbirth - Menstruation and menopauseMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12605000278639
- Lead Sponsor
- Professor I Reid
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Postmenopausal 5 yrs or more, bone density T score between -1.0 and -2.0 at lumbar spine or total hip.
Renal impairment (serum creatinine >0.15 mmol/L), chronic liver disease, untreated hypothyroidism or hyperthyroidism, concurrent major systemic illness, malignancy, active major gastrointestinal disease, metabolic bone diseases, or serum ALP > 2x normal limit, primary hyperparathyroidism, previous fragility fracture of the hip or spine. Use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months, current or past use of bisphosphonate therapy, use of hormone replacement therapy within the last 12 months, use of other medication known to cause osteoporosis or interfere with bone metabolism.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The time to normalisation of bone turnover markers in the zoledronate treated group where normalisation is defined as when the mean of a bone turnover marker in the zoledronate treated group lies within 20% of the mean value of that marker in the placebo treated group.[]
- Secondary Outcome Measures
Name Time Method The difference between the change in bone turnover markers.[Over 3 years in the zoledronate-treated group compared to the change in the control group.];The difference between the change in spine and hip bone density.[Over 3 years in the zoledronate-treated group compared to the change in the control group.]