Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial.
OBJECTIVE
Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy.


METHODS
We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months.


RESULTS
At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p </= 0.001), trochanter (treatment difference 1.66%; p = 0.007), and total hip (treatment difference 1.19; p = 0.008) BMD. Biochemical markers of bone remodeling also showed significant mean percentage decreases from baseline.


CONCLUSIONS
Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip.
Stoch
S Aubrey
SA
Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ 07065. aubrey_stoch@merck.com.
Saag
Kenneth G
KG
Greenwald
Maria
M
Sebba
Anthony I
AI
Cohen
Stanley
S
Verbruggen
Nadia
N
Giezek
Hilde
H
West
Joseph
J
Schnitzer
Thomas J
TJ
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D019386:Alendronate / Q000008:administration & dosage*; D015415:Biomarkers / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D002118:Calcium / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects*; D006621:Hip Joint / Q000187:drug effects; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced* / Q000188:drug therapy* / Q000517:prevention & control; D010919:Placebos; D012216:Rheumatic Diseases / Q000188:drug therapy*; D014807:Vitamin D / Q000008:administration & dosage
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D005938:Glucocorticoids; D010919:Placebos; D014807:Vitamin D; D002118:Calcium; D019386:Alendronate