Effect of zoledronic acid compared with raloxifene on bone turnover markers in postmenopausal women with low bone density.

Abstract

OBJECTIVE:

The aim of this study was to assess the effects of zoledronic acid and raloxifene on bone turnover markers.

METHODS:

This multicenter, randomized, double-blind study involved 110 postmenopausal women with low bone mineral density who received either a single intravenous infusion of zoledronic acid 5 mg or 6 months of daily oral raloxifene 60 mg. The primary efficacy variable was change from baseline in the bone resorption marker urine N-telopeptide of type I collagen. The secondary efficacy variable was change from baseline in the bone formation marker serum bone-specific alkaline phosphatase. Analysis time points were at 2, 4, and 6 (primary) months.

RESULTS:

At 6 months, zoledronic acid produced a significantly greater reduction than did raloxifene in urine N-telopeptide of type I collagen (P < 0.001). Zoledronic acid also yielded significantly greater decreases in urine N-telopeptide of type I collagen at 2 and 4 months and in serum bone-specific alkaline phosphatase at all time points (P < 0.001 vs raloxifene for all comparisons). Both treatments were well tolerated. More adverse events occurred in the zoledronic acid group; these were primarily transient postdose symptoms that occurred within the first 3 days after the infusion.

CONCLUSIONS:

Zoledronic acid demonstrated significantly greater decreases in bone turnover markers than did raloxifene in postmenopausal women with low bone mass.

• Authors: Gloria Bachmann, Audrey Kriegman, Joana Gonçalves, Farid Kianifard, Michelle Warren, James A Simon
• Journal: Menopause (New York, N.Y.) (Menopause) Vol. 18 Issue 8 Pg. 851-6 (Aug 2011) ISSN: 1530-0374 [Electronic] United States
• PMID: 21796066 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Biomarkers
• Bone Density Conservation Agents
• Collagen Type I
• Diphosphonates
• Imidazoles
• Peptides
• Selective Estrogen Receptor Modulators
• collagen type I trimeric cross-linked peptide
• Zoledronic Acid

Topics

• Aged
• Biomarkers (urine)
• Bone Density (drug effects)
• Bone Density Conservation Agents (administration & dosage, pharmacology)
• Bone Remodeling (drug effects)
• Collagen Type I (urine)
• Diphosphonates (administration & dosage, pharmacology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Imidazoles (administration & dosage, pharmacology)
• Infusions, Intravenous
• Middle Aged
• Osteoporosis, Postmenopausal (drug therapy, urine)
• Peptides (urine)
• Selective Estrogen Receptor Modulators (administration & dosage, pharmacology)
• United States
• Zoledronic Acid