Oral weekly ibandronate prevents bone loss in postmenopausal women

Abstract

Objectives. To investigate the efficacy, safety, and dose-response of once-weekly oral ibandronate in the prevention of postmenopausal bone loss. Design. This was a multi-centre, placebo-controlled, double-blind, randomized, 24-month phase II/III dose-finding study. Setting. Primary care units in 14 osteoporosis centres. Subjects. A total of 630 women were stratified into four strata according to time since menopause (TSM, 1-3 vs. >3 years) and baseline bone mineral density (BMD; normal: T-score ‡1 vs. osteopenic: )2.5 £ Tscore £ 1) of the lumbar spine. Interventions. Within each stratum women were further randomized to receive once-weekly ibandronate (5, 10, or 20 mg week )1 ) or placebo for 24 months.Main outcome measures. Efficacy parameters were the relative changes from baseline in spine (L1-4) and hip BMD, and biochemical markers of bone turnover (serum and urinary C-telopeptide of collagen type I (CTx), osteocalcin, and alkaline phosphatase) measured by dual energy X-ray absorptiometry and enzyme immunoassays, respectively.Results. Once-weekly therapy with ibandronate induced dose-dependent increases in spine and hip BMD. At month 24, differences between the relative changes in spine and hip BMD induced by 20 mg ibandronate and placebo was 4.0 and 2.7%, respectively. Similar or more pronounced differences were seen in osteopenic women of TSM 1-3 years (5.3 and 3.5%) and of TSM >3 years (3.5 and 2.9%), respectively. A dose-dependent suppression of all biochemical markers of bone turnover was observed with significant decreases in the 20 mg dose groups of all strata at month 24. The overall safety results indicated that once-weekly oral ibandronate was well-tolerated at all three doses. Conclusion. Once-weekly oral therapy with 20 mg ibandronate provides an effective and safe therapy for the prevention of postmenopausal bone loss.

Preventing osteoporosis in symptomatic postmenopausal women

“…Less frequent dosing with ibandronate has also been investigated in the prevention of osteoporosis. 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.…”

Composite ceramic containing a bioresorbable phase

“…One reason that materials containing CPP have been excluded from studies could be the fact that CPP is present in the joints of people suffering from arthritis and arthroses. Nonetheless, the pyrophosphate ion is the main structural unit of biphosphonates [4], which are the base of many pharmaceuticals for treating osteoporosis and diabetes mellitus [5].…”

An update on bisphosphonates

“…A recent report of a clinical trial evaluating 520 women with postmenopausal osteoporosis using 2 mg intravenously every 3 months demonstrated comparable BMD changes, and suppression of bone turnover markers reported with other nitrogen-containing BPs, but fracture data were not reported [37]. A preliminary report from a bone loss prevention trial in postmenopausal women evaluated once-weekly 5-, 10-, and 20-mg ibandronate and placebo over 24 months and confirmed improvement in lumbar spine BMD (3.5% to 5.3%) and total hip (2.9% to 3.5%) similar to that seen with other nitrogencontaining BPs [38].…”