Efficacy of Zoledronate in fracture prevention in osteopenic postmenopausal women.

Phase 4

Active, not recruiting

• Conditions: Fractures in women with Postmenopausal osteopenia; Musculoskeletal - Osteoporosis; Injuries and Accidents - Fractures

• Registration Number: ACTRN12609000593235
• Lead Sponsor: Professor Ian Reid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first osteoporotic fracture in osteopenic postmenopausal women. Fracture assessed by verified xray reports or film.[at six years from randomisation]