Clodronate is effective in preventing corticosteroid-induced bone loss among asthmatic patients.
Clodronate is a novel drug used for inhibiting osteoclastic activity. The aim of the present double-blind study was to evaluate the efficacy and tolerability of clodronate (Leiras, Finland) in corticosteroid-induced bone loss among asthmatic patients. Seventy-four adult patients (41 women and 33 men, mean age 57.3 years) having a long history (mean 8.1 years) of oral and inhaled corticosteroid therapy were randomized to four parallel treatment groups: clodronate 800, 1600, or 2400 mg/day, or an identical placebo. The bone mineral density (BMD) of the lumbar spine (L2-4), femoral neck, and trochanter were assessed using dual-energy X-ray absortiometry at entry, 6 months, and 12 months. The baseline BMDs did not differ significantly between the study groups. In the lumbar spine, the mean BMD increased significantly between the baseline and 12-month visit in the clodronate groups of 1600 and 2400 mg/day, 2.6% (0.02 g/cm2, p < 0.02) and 3.0% (0.03 g/cm2, p < 0.01), respectively, but not in the placebo and clodronate 800 mg/day groups. The test for a linear trend (BMD percent change for L2-4) at 12 months was significant (p < 0.02), indicating a dose response to clodronate. The mean BMD values of the femoral neck increased significantly in the 2400 mg/day group, 4.3% (0.03 g/cm2, p < 0.0001), as well as in the trochanter region 2.8% (0.02 g/cm2, p < 0.02). Gastric irritation was the most common adverse effect noted on a clodronate dose of 2400 mg/day. We conclude that oral clodronate is effective in preventing bone loss or increasing bone mass in asthmatic patients having a long history of continuous peroral and inhaled corticosteroid administration.
Herrala
J
J
University of Tampere, Medical School, Department of Respiratory Medicine, Finland.
Puolijoki
H
H
Liippo
K
K
Raitio
M
M
Impivaara
O
O
Tala
E
E
Nieminen
M M
MM
D015502:Absorptiometry, Photon; D000280:Administration, Inhalation; D000284:Administration, Oral; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects; D015519:Bone Density / Q000187:drug effects*; D004002:Clodronic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005269:Femur / Q000187:drug effects; D005272:Femur Neck / Q000187:drug effects; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects; D008297:Male; D010024:Osteoporosis / Q000139:chemically induced / Q000517:prevention & control*; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects
D018712:Analgesics, Non-Narcotic; D018927:Anti-Asthmatic Agents; D005938:Glucocorticoids; D004002:Clodronic Acid; D011239:Prednisolone; D001507:Beclomethasone