Clinical trial: comparison of alendronate and alfacalcidol in glucocorticoid-associated osteoporosis in patients with ulcerative colitis.
BACKGROUND
Bone loss is often observed in patients with ulcerative colitis, particularly if they require glucocorticoids.


OBJECTIVE
To determine whether the bisphosphonate, alendronate, is safe and effective in preserving bone mass compared to the active vitamin D3, alfacalcidol, in ulcerative colitis patients receiving glucocorticoids.


METHODS
Thirty-nine patients with ulcerative colitis and treated with glucocorticoids were randomized to receive alendronate (5 mg/day) or alfacalcidol (1 microg/day) daily for 12 months. Loss of bone mass was evaluated by bone mineral density, bone resorption by urinary N-telopeptide for type I collagen, and bone formation by serum bone alkaline phosphatase.


RESULTS
Alendronate, but not alfacalcidol, significantly increased bone mineral density in the lumbar spine. Alendronate decreased serum bone alkaline phosphatase levels, but alfacalcidol did not. Urinary N-telopeptide for type I collagen levels decreased in both groups, but were significantly lower in the alendronate group. There were no significant differences in the adverse events in the two groups.


CONCLUSIONS
Our study indicates that alendronate is a safe, well-tolerated and more effective therapy than alfacalcidol for preventing glucocorticoid-associated bone loss in patients with ulcerative colitis.
Kitazaki
S
S
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
Mitsuyama
K
K
Masuda
J
J
Harada
K
K
Yamasaki
H
H
Kuwaki
K
K
Takedatsu
H
H
Sugiyama
G
G
Tsuruta
O
O
Sata
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D019386:Alendronate / Q000008:administration & dosage / Q000009:adverse effects*; D015415:Biomarkers / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D006887:Hydroxycholecalciferols / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000188:drug therapy*; D010865:Pilot Projects
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D005938:Glucocorticoids; D006887:Hydroxycholecalciferols; C008088:alfacalcidol; D019386:Alendronate