Ob/Gyn Medical News about Zoledronic acid, Reclast, Osteoporosis, Postmenopausal

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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

Results

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