N/A
N=181
Zoledronic Acid for Osteoporosis in the Elderly
Osteoporosis · Bone Loss · Fragility Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00558012 ↗Enrolled (actual)
181
Serious AEs
63.5%
Results posted
Jul 2015
Primary outcome: Primary: Bone Mineral Density (BMD) of the Total Hip and Spine — 4.5; 0.7; 3.0; 1.1 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intravenous zoledronic acid (Drug); Vitamin D 800 IU/daily (Dietary_supplement); Calcium 1200 mg/daily (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density (BMD) of the Total Hip and Spine |
4.5; 0.7; 3.0; 1.1; 2.6; -1.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- We will include elderly women 65 years and older if they reside in a nursing home or an assisted living facility and have a known history of osteoporosis, as determined by history of an adult fragility fracture or bone mineral density criteria for osteoporosis (T-score -2.5 at the total hip, femoral neck or spine) or low bone mass (T-score 20 ng/ml.
- Patients will be allowed to continue on certain medications known to affect bone and mineral metabolism (e.g. glucocorticoids, anticonvulsants) because their use is common in this population. (In our facilities, 2.9% of patients use glucocorticoids and 7.2% use anti-epileptic drugs.) In addition, women who have been treated in the past or present with osteoporosis agents, such as estrogen/progesterone, raloxifene, and calcitonin, will be allowed to participate and continue on these therapies if prescribed by their physician. However, if patients are currently on or have been on bisphosphonates for greater than 1 year in the previous 2 years prior to enrollment, they will be excluded as some bisphosphonates are long acting.
- Patients will be allowed to wear hip pads if prescribed by their physician. If they are on parathyroid hormone, they may participate, but will be told that monotherapy with parathyroid hormone is more beneficial than combination therapy with parathyroid hormone and alendronate, as we have previously demonstrated.
Data sourced from ClinicalTrials.gov (NCT00558012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.