Zoledronate and fracture prevention in early postmenopausal wome

Phase 4

Completed

• Conditions: Osteoporosis; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12612000270819
• Lead Sponsor: Dr Mark Bolland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-06
• Study Completion: 2023-10-25
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1054

Inclusion Criteria

Postmenopausal women aged 50-60 years.
Bone mineral density T score at the lumbar spine, femoral neck or total hip < 0

Exclusion Criteria

Bone mineral density T score <-2.5 at the total hip, femoral neck or lumbar spine.
Renal impairment (estimated glomerular filtration rate > 45 ml/min).
Untreated hypothyroidism or hyperthyroidism.
Chronic liver disease.
Concurrent major systemic illness, including malignancy.
Active major gastrointestinal disease.
Metabolic bone diseases.
Previous fragility fracture of the hip or spine.
Current or past use of bisphosphonate therapy within 12 months, or past zoledronic acid use.
Use of oral glucocorticoid drugs equivalent to an average dose of at least prednisone 2.5mg/day during the preceding 6 months.
Use of hormone replacement therapy within 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ew morphometric vertebral fractures since baseline assessed using thoracic and lumbar spine plain x-rays[ Thoracic and spinal x-rays will be taken at baseline, 5 years, and 10 years in all participants.]