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Monitoring of alendronate treatment and prediction of effect on bone mass by biochemical markers in the early postmenopausal intervention cohort study.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 1999 Jul; Vol. 84 (7), pp. 2363-8. - Publication Year :
- 1999
-
Abstract
- To establish whether biochemical markers could be used to monitor alendronate (ALN) treatment and predict long-term response in bone mass, we used results from an ongoing, randomized trial of ALN treatment for prevention of postmenopausal osteoporosis (n = 1202). In women treated with ALN (5 mg), change from baseline at month 6 in urine N-telopeptide cross-links of type I collagen (NTX) and osteocalcin (OC) correlated with change from baseline at month 24 in spine, hip, and total body bone mineral density (BMD) [r = -0.28 to -0.31 (NTX) and r = -0.16 to -0.25 (OC), P<0.001]. This corresponded to a 4- to 5-fold greater increase at month 24 in BMD in the tertiles, with the greatest decrease at month 6 in NTX or OC. In women treated with ALN (5 mg) who had a change at month 24 in spine BMD of at least 0%, 86% (NTX) and 79% (OC) had a decrease at month 6 of at least 40% (NTX) or 20% (OC) (sensitivity). The corresponding specificities were 48% (NTX) and 53% (OC). In conclusion, change at month 6 in NTX and OC, in groups of women treated with ALN, indicated the numeric long-term response in BMD within these groups. In individual women, a decrease at month 6, in NTX or OC below the cut-point, validly identified women who responded, on ALN treatment, with a stabilization or an increase in bone mass. However, lack of decrease below the cut-point in NTX or OC could not be used to identify women with a bone loss during ALN treatment.
- Subjects :
- Alendronate administration & dosage
Cohort Studies
Collagen urine
Collagen Type I
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Middle Aged
Osteocalcin blood
Peptides urine
Placebos
Sensitivity and Specificity
Alendronate therapeutic use
Biomarkers analysis
Bone Density
Osteoporosis, Postmenopausal prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 0021-972X
- Volume :
- 84
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 10404804
- Full Text :
- https://doi.org/10.1210/jcem.84.7.5847