Sustained-release sodium fluoride in the treatment of the elderly with established osteoporosis.

Abstract

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.

CONCLUSION:

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.

• Authors: C D Rubin, C Y Pak, B Adams-Huet, H K Genant, J Li, D S Rao
• Journal: Archives of internal medicine (Arch Intern Med) Vol. 161 Issue 19 Pg. 2325-33 (Oct 22 2001) ISSN: 0003-9926 [Print] United States
• PMID: 11606148 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Collagen Type I
• Delayed-Action Preparations
• Peptides
• collagen type I trimeric cross-linked peptide
• Cholecalciferol
• Sodium Fluoride
• Collagen
• Calcium Citrate
• Calcium

Topics

• Aged
• Ambulatory Care
• Blood Cell Count
• Bone Density (drug effects)
• Calcium (urine)
• Calcium Citrate (administration & dosage, therapeutic use)
• Cholecalciferol (administration & dosage, therapeutic use)
• Collagen (urine)
• Collagen Type I
• Delayed-Action Preparations (administration & dosage, therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Occult Blood
• Osteoporosis, Postmenopausal (blood, diagnostic imaging, drug therapy)
• Peptides (urine)
• Radiography
• Reticulocyte Count
• Sodium Fluoride (administration & dosage, blood, therapeutic use)
• Spinal Fractures (blood, diagnostic imaging, prevention & control)