Conditions: Osteoporosis Bone Loss Fragility Fractures
Keywords: Osteoporosis Bone loss Frail Geriatric Women Nursing Home Patients Fragility Fractures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 181
Healthy volunteers: no

Brief summary:
This trial will examine the safety, efficacy and feasibility of a single dose of intravenous zoledronic acid in the maintenance of skeletal integrity for frail, institutionalized women, who are most at risk for the deleterious outcomes of osteoporosis. The investigators will test the hypothesis that in institutionalized elderly women a single dose of intravenous zoledronic acid therapy will: (1) be efficacious as demonstrated by stability or improvement in bone mass measurements and reductions in bone turnover; (2) be safe and feasible; and (3) provide estimates for vertebral and nonvertebral fracture reduction in this cohort for use in planning a future study.

Detailed description:
This is a 2-year, randomized, double-blind, calcium/vitamin D-controlled clinical trial of a single dose of therapy with at least 12 months follow-up. All participants will receive calcium and vitamin D throughout the trial. At baseline, 190 women will be randomized in a 1:1 allocation to zoledronic acid (group 1) or zoledronic acid placebo (group 2). At the end of 24 months, women will be followed to gather data on longer term fragility fracture rates and survival until all participants have completed 24 months of follow-up.

Arms:
arm 1: One-time dose: Intravenous Zoledronic Acid 5.0 mg; Vitamin D (800 IU/daily); Calcium 1200 mg/daily (supplement plus diet) arm 2: One-time dose: intravenous saline; Vitamin D (800 IU/daily); 1200 mg calcium (supplement plus diet)

Interventions: intervention 1: Intravenous zoledronic acid intervention 2: Vitamin D 800 IU/daily intervention 3: Calcium 1200 mg/daily
Intervention descriptions: intervention 1: Intravenous zoledronic acid 5.0 mg once intervention 2: Daily divided dose intervention 3: supplement plus diet

Protocol document: