Prevention in Postmenopausal Women
Ibandronate sodium is used for the prevention of osteoporosis in postmenopausal women. Risk factors include a family history of osteoporosis, early menopause, previous fracture, high bone turnover, reduced bone mineral density (at least 1 standard deviation below premenopausal mean), thin body frame, Caucasian or Asian race, excessive alcohol intake, treatment with certain drugs (e.g., corticosteroids), low dietary calcium or vitamin D intake, a sedentary lifestyle, and cigarette smoking. For additional information on osteoporosis, .
Efficacy of oral ibandronate in the prevention of osteoporosis was established in a 2-year, randomized, double-blind, placebo-controlled, dose-ranging study in postmenopausal women (41-82 years of age). In this study, ibandronate given at a dosage of 2.5 mg daily was more effective than placebo in increasing bone mineral density (BMD) of the lumbar spine and total hip.
Efficacy of oral ibandronate given once monthly for the prevention of osteoporosis has been demonstrated in a 1-year, randomized, double-blind, placebo-controlled study in 160 postmenopausal women (46-60 years of age) with low baseline bone mass. Women in the study were 5.4 years postmenopause on average, and all women received supplementation with 400 units of vitamin D and 500 mg of calcium daily. Therapy with ibandronate 150 mg once monthly was associated with a mean increase in lumbar spine BMD of 4.12% from baseline relative to placebo; BMD at other skeletal sites also increased relative to baseline values.
Treatment in Postmenopausal Women
Ibandronate sodium also is used in the treatment of osteoporosis in postmenopausal women. Efficacy of ibandronate given as a daily or once-monthly oral regimen has been established in several randomized, double-blind, multinational, dose-comparison studies in postmenopausal women with osteoporosis.
In a placebo-controlled study in postmenopausal women with osteoporosis, the rate of new vertebral fractures after 3 years of treatment (the primary end point) was substantially reduced in women receiving oral ibandronate daily (2.5 mg once daily) or intermittently (20 mg every other day for 12 doses every 3 months) compared with that in patients receiving placebo. The diagnosis of a vertebral fracture was based on qualitative diagnosis by a radiologist and on quantitative morphometric criteria (an absolute decrease in height of at least 4 mm and a relative height ratio or relative height reduction in a vertebral body of at least 20%). Over the course of the 3-year study, new vertebral fractures were found in 4.7, 4.9, or 9.6% of women receiving ibandronate 2.5 mg daily, 20 mg every other day, or placebo, respectively (relative risk reduction of 52% with daily or 50% with intermittent ibandronate, respectively, compared with placebo). The incidence of nonvertebral fractures at 3 years (a secondary end point) was similar with the active treatments; 9.1 or 8.9% with daily or intermittent ibandronate, respectively, compared with 8.2% with placebo. BMD at 3 years relative to baseline BMD (a secondary end point) increased appreciably at the lumbar spine, total hip, femoral neck, and trochanter with either daily or intermittent ibandronate therapy compared with placebo.
In a 2-year noninferiority trial comparing oral ibandronate administered monthly (100 or 150 mg once monthly) or daily (2.5 mg once daily), an ibandronate dosage of 150 mg once monthly was at least as effective as 2.5 mg once daily in increasing BMD of the lumbar spine (primary end point at 1 year) in postmenopausal women with osteoporosis. Analysis of other skeletal sites (secondary end points) indicated consistently higher BMDs of the total hip, femoral neck, and trochanter with a dosage of 150 mg once monthly compared with 2.5 mg once daily.
In a trial comparing IV ibandronate administered quarterly (3 mg once every 3 months) or bimonthly (2 mg every 2 months) with daily oral ibandronate (2.5 mg once daily), both IV regimens were more effective than the daily oral regimen in increasing BMD of the lumbar spine at 1 year compared with baseline (the primary end point) in postmenopausal women with osteoporosis.
Bone histology studies in a limited number of postmenopausal women with osteoporosis treated with oral ibandronate (2.5 mg daily for 34 months), quarterly IV ibandronate (3 mg every 3 months for 22 months), or bimonthly IV ibandronate (2 mg every 2 months for 23 months) indicated bone formation of normal quality without evidence of mineralization defects or osteomalacia during treatment with the drug.
(See Musculoskeletal Pain under Warnings/Precautions: General Precautions, in Cautions.)