Abstract | BACKGROUND: 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.
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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.)
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Chemical References |
- Collagen Type I
- Delayed-Action Preparations
- Peptides
- collagen type I trimeric cross-linked peptide
- Cholecalciferol
- Sodium Fluoride
- Collagen
- Calcium Citrate
- Calcium
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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)
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