Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis.
BACKGROUND
Persistence with osteoporosis treatment is poor but is important for maximum benefit.


OBJECTIVE
The objective of the study was to assess the impact of physician reinforcement using bone turnover markers (BTMs) on persistence with risedronate treatment.


METHODS
This was a 1-yr multinational prospective, open-label, blinded study in 171 osteoporosis centers in 21 countries.


METHODS
A total of 2382 postmenopausal women (65-80 yr old) with spine/hip T-score -2.5 or less or T-score -1.0 or less with a low-trauma fracture.


METHODS
Intervention included calcium 500 mg/d, vitamin D 400 IU/d, and risedronate 5 mg/d for 1 yr. Centers were randomized to reinforcement (RE+) or no reinforcement (RE-). At 13 and 25 wk, reinforcement based on urinary N-telopeptide of type I collagen change from baseline was provided to the RE+ patients using the following response categories: good (>30% decrease), stable (-30% to +30% change), or poor (>30% increase).


METHODS
Persistence assessed with electronic drug monitors was measured.


RESULTS
In the overall efficacy population (n=2302), persistence was unexpectedly high and was similar for both groups (RE-, 77%; RE+, 80%; P=0.160). A significant relationship between the type of message and persistence was observed (P=0.017). Compared with RE-, intervention based on a good BTM response was associated with a significant improvement in persistence [hazard ratio (HR) 0.71; 95% confidence interval (CI) 0.53-0.95]. Persistence was unchanged (HR 1.02; 95% CI 0.74-1.40) or lower (HR 2.22; 95% CI 1.27-3.89) when reinforcement was based on a stable or poor BTM response, respectively. Reinforcement was associated with a lower incidence of new radiologically determined vertebral fractures (odds ratio 0.4; 95% CI, 0.2-1.0).


CONCLUSIONS
Reinforcement using BTMs influences persistence with treatment in postmenopausal women with osteoporosis, depending on the BTM response observed.
Delmas
Pierre D
PD
Institut National de la Santé et de la Recherche Médicale Research Unit 403 and University Claude Bernard, Hôpital Edouard Herriot, Pavillon F, 69437 Lyon Cedex 03, France. delmas@lyon.inserm.fr
Vrijens
Bernard
B
Eastell
Richard
R
Roux
Christian
C
Pols
Huibert A P
HA
Ringe
Johann D
JD
Grauer
Andreas
A
Cahall
David
D
Watts
Nelson B
NB
D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001842:Bone and Bones / Q000378:metabolism*; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010349:Patient Compliance; D011446:Prospective Studies; D000068296:Risedronic Acid; D016312:Treatment Refusal
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid; D012968:Etidronic Acid