Efficacy of Zoledronate in fracture prevention in osteopenic postmenopausal women.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000593235

Enrollment

2000

Registered

2009-07-17

Start date

2009-09-28

Completion date

2011-10-17

Last updated

2026-09-07

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 study is to determine whether the administration of the bone strengthening drug Zoledronate will reduce the numbers of fractures occurring in women who have low bone density but whose densities are not low enough to be classified as having osteoporosis.

Interventions

Intravenous Zoledronate 5mg/100ml infused over 15 minutes every 18 months for 6 years (4 injections at Baseline, 18,36and 54 months)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

65 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Female subjects only will be studied They must be >5years postmenopausal and aged >65 years Life expectancy >5years Total hip T-score <-1.0 and >-2.5 at either hip

Exclusion criteria

Renal impairment (estimated Glomerular Filtration Rate <30 ml/minute) Untreated hypo or hyperthyroidism Active liver disease Concurrent major systemic disease Active malignancey (other than skin cancers) within the last 2 years or still requiring treatment (eg anti-estrogens) Metabolic bone disease Regular use of Hormone Replacement Therapy within the previous 1 year Treatment with bisphosphonates in the previous 1 year Current treatment with glucocorticoid drugs Regular use of other bone-active drugs in the previous year Bone Mineral Density of Lumbar spine (L1-4) <-3.0

Outcome results