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Zoledronic acid (Reclast): Bisphosphonate approved for the prevention of osteoporosis in postmenopausal women
Formulary , 07/08/09
Formulary Journal Staff – For the prevention of osteoporosis in postmenopausal women, a 5-mg infusion of zoledronic acid should be administered iv over ≥15 minutes every 2 years. Patients should be adequately supplemented with calcium and vitamin D if dietary intake is not sufficient. Caution: patients with hypocalcemia or with hypersensitivity to zoledronic acid should not be treated with this agent.
Methods- 2 yr trial to report the efficacy of zoledronic acid for the prevention of postmenopausal osteoporosis
- Pts (n=581) were stratified by the number of yrs since menopause:
- Stratum I: <5 years since menopause
- Stratum II, ≥5 yrs since menopause
- Pts were randomized to treatment with:
- Zoledronic acid (5-mg infusion) at randomization and at month 12
- Zoledronic acid (5-mg infusion) at randomization and placebo at month 12, or
- Placebo at randomization and at month 12
- All women also received supplemental calcium and vit D
- Primary end point: % change from baseline in BMD at 24 mo
- Zoledronic acid administered at randomization (with placebo at month 12) was associated with:
- 6.3% increase in lumbar spine BMD in Stratum 1
- 5.4% increase in lumbar spine BMD in Stratum II vs placebo, and
- 4.7% increase in total hip BMD in Stratum I
- 3.2% increase in total hip BMD in Stratum II
- relative to placebo at 24 mo
- Hypocalcemia and mineral metabolism disturbances must be treated before initiation of zoledronic acid therapy
- This agent should not be used in pts with severe renal impairment
- An oral examination should be performed before initiation of bisphosphonate therapy
- Pts with concomitant risk factors should avoid invasive dental procedures during bisphosphonate therapy if possible
- Zoledronic acid should not be used during pregnancy
- Zoledronic acid should be used with caution in aspirin-sensitive pts
- Most common AEs associated with zoledronic acid when used for the prevention of postmenopausal osteoporosis: arthralgia, pyrexia, myalgia, pain, chills, headache, and back pain
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