Intravenous ibandronate injections given every three months: a new treatment option to prevent bone loss in postmenopausal women

Abstract

Objective: To investigate the efficacy, safety, and dose response of three doses of ibandronate, given intermittently by intravenous (IV) injection every three months, in preventing postmenopausal osteoporosis. Patients and methods: 629 postmenopausal women, categorised according to time since menopause and baseline lumbar spine (L1-4) bone mineral density (BMD), were enrolled into a multicentre, double blind, placebo controlled trial. They were randomly allocated to receive IV ibandronate 0.5 mg, 1 mg or 2 mg, or placebo every three months. All women received daily calcium supplementation.Results: One year's treatment with intermittent IV ibandronate injections produced a dose dependent gain in mean (SD) lumbar spine BMD from baseline of 2.5 (2.5)%, 1.8 (2.6)%, and 1.0 (2.8)% in the groups receiving 2 mg, 1 mg, and 0.5 mg ibandronate, respectively, compared with a loss of BMD of 0.4 (2.4)% in the women in the placebo group; p=0.0001 for each ibandronate dose v placebo. Highest BMD gains occurred in women with osteopenia receiving 2 mg ibandronate. Similarly, at the hip, all three doses of ibandronate produced significantly better gains in BMD than placebo (p<0.05), with the greatest gains in the women with osteopenia receiving the 2 mg dose. Ibandronate concomitantly and dose dependently suppressed markers of bone turnover in comparison with placebo, and injections were well tolerated. Conclusion: IV ibandronate injections, given every three months, may be an effective alternative to oral bisphosphonates and hormonal therapy in the prevention of bone loss in postmenopausal women.

Preventing osteoporosis in symptomatic postmenopausal women

“…In a 2-year randomized study 64 involving 630 women, the maximum relative change in BMD with ibandronate 20 mg/week compared with placebo was 4.0% at the spine and 2.7% at the hip (P G 0.05 for both). 65 Intermittent dosing of bisphosphonates is now a common clinical practice in the treatment of women with postmenopausal osteoporosis 66 and may also be a useful strategy for the prevention of bone loss in postmenopausal women who do not have osteoporosis. In a recent study 67 of postmenopausal women (aged 45-60 y) with low BMD, 1 year of treatment with monthly oral ibandronate significantly increased lumbar spine BMD by 3.7% compared with placebo (P G 0.0001).…”

Postmenopausal osteoporosis

“…Many clinicians use intermittent infusions of pamidronate under these circumstances. Preliminary results suggest that three monthly injections of ibandronate [15] or annual injections of zoledronate [16] may be effective at suppressing bone turnover and increasing bone density. Neither of these studies have yet demonstrated efficacy in reducing fracture rates in postmenopausal osteoporosis and therefore cannot be recommended for general use, although studies using fracture end points are in place for both compounds.…”

Bisphosphonates for the Treatment of Postmenopausal Osteoporosis: An Update

“…A number of RCTs have evaluated the effect of different ibandronate doses/regimens on bone mineral density (Table 1) [27,28,[30][31][32][33]. In a 1-year randomized treatment trial of 520 postmenopausal women (BMD T scores \ -2.5), Adami compared 1 and 2 mg doses of ibandronate given intravenously every 3 months to control.…”

“…[32]. McClung et al in a 2-year prevention trial of daily ibandronate randomized 653 postmenopausal women to one of four arms: calcium plus placebo or ibandronate 0.5, 1.0 or 2.5 mg daily.…”