Sustained-release sodium fluoride in the treatment of the elderly with established osteoporosis.
BACKGROUND
We ascertained the safety and efficacy of fluoride in augmenting spinal bone mass and reducing spinal fractures in older women with established osteoporosis. We compared a combination of sustained-release sodium fluoride, calcium citrate, and cholecalciferol (SR-NaF group) with calcium and cholecalciferol alone (control group).


METHODS
Eighty-five ambulatory women aged 65 years or older with 1 or more nontraumatic vertebral compression fractures were enrolled in a 42-month randomized, double-blind, placebo-controlled trial. Primary outcome measures were vertebral fracture rate, bone mass, and safety.


RESULTS
The vertebral fracture rate determined by means of computer assistance in the SR-NaF group was significantly lower than that in the control group (relative risk [RR], 0.32; 95% confidence interval [CI], 0.14-0.73; P =.007). Results of visual adjudicated inspection also confirmed a significant reduction in fracture rate (RR, 0.40; 95% CI, 0.17-0.95; P =.04). Bone mineral density in L2 through L4 increased significantly from baseline in the SR-NaF group by 5.4% (95% CI, 2.7%-8.2%; P<.001), and by 3.2% in the control group (95% CI, 0.8%-5.6%; P =.01). The between-group differences in bone mineral density were not significant. The femoral neck and total hip bone mineral density remained stable in the SR-NaF group and was not significantly different from that of the control group. There were no significant differences in adverse effects between groups.


CONCLUSIONS
The SR-NaF group significantly decreased the risk for vertebral fractures and increased spinal bone mass without reducing bone mass at the femoral neck and total hip.
Rubin
C D
CD
Geriatrics Section, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-8889, USA. Craig.Rubin@UTSouthwestern.edu
Pak
C Y
CY
Adams-Huet
B
B
Genant
H K
HK
Li
J
J
Rao
D S
DS
D000368:Aged; D000553:Ambulatory Care; D001772:Blood Cell Count; D015519:Bone Density / Q000187:drug effects; D002118:Calcium / Q000652:urine; D019355:Calcium Citrate / Q000008:administration & dosage / Q000627:therapeutic use; D002762:Cholecalciferol / Q000008:administration & dosage / Q000627:therapeutic use; D003094:Collagen / Q000652:urine; D024042:Collagen Type I; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D009780:Occult Blood; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy*; D010455:Peptides / Q000652:urine; D011859:Radiography; D017701:Reticulocyte Count; D012969:Sodium Fluoride / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use*; D016103:Spinal Fractures / Q000097:blood / Q000000981:diagnostic imaging / Q000517:prevention & control*
D024042:Collagen Type I; D003692:Delayed-Action Preparations; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D002762:Cholecalciferol; D012969:Sodium Fluoride; D003094:Collagen; D019355:Calcium Citrate; D002118:Calcium