None listed
Conditions
Brief summary
Low bone density is a strong risk factor for fracture, but 80% of fractures occur in women without low bone density. We plan to investigate whether zoledronate, an effective osteoporosis treatment, can be given very infrequently by injection to prevent bone loss and spinal fractures in women with normal or only mildly low bone density. The proposed study is a prospective, randomised, double-blind, placebo-controlled, trial to be carried out over a period of ten years. 1050 post-menopausal women, aged 50-60 years, will be randomly assigned to receive either infusions of zoledronate or an inactive agent (placebo) at baseline and at five years. There will be three treatment groups- women who receive zoledronate at baseline and five years, women who receive zoledronate at baseline and placebo at five years, and women who receive placebo at baseline and five years. The main outcomes are occurrence of new spinal fractures and changes in bone density. Participants will have study visits every 5 years, and phone or email visits every six months, and at baseline, five years, and 10 years, participants will have a measurement of bone density and xrays of the spine.
Interventions
Arm 1: Intravenous infusion of 5mg zoledronic acid at baseline and an intravenous infusion of placebo (saline solution) at 5 years. (Total of two infusions during study)
Arm 2: Intravenous infusion of 5mg zoledronic acid at baseline and 5 years. (Total of two infusions during study)
Sponsors
Dr Mark Bolland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 60 Years
Healthy volunteers
Yes
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
Outcome results
None listed