Relationship between 3-month changes in biochemical markers of bone remodelling and changes in bone mineral density and fracture incidence in patients treated with strontium ranelate for 3 years.
CONCLUSIONS
From two randomised controlled trials, it is shown that 3-month changes in biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) were associated with 3-year bone mineral density (BMD) changes, but not fracture incidence in patients treated with strontium ranelate.


BACKGROUND
The purpose of this study was to assess if short-term change in biochemical markers of bone remodelling is associated with long-term BMD change and fracture incidence observed during treatment with strontium ranelate.


METHODS
From the SOTI and TROPOS trials, bone-specific alkaline phosphatase (BALP), C-terminal propeptide of type I procollagen (PICP), serum C-terminal telopeptides (S-CTX) and urine N-terminal telopeptides of type I collagen (U-NTX) were assessed at baseline and after 3 months.


RESULTS
Two thousand three hundred seventy-three women were included in this study. Multiple regression analysis showed that 3-month changes in PICP and BALP but not s-CTX I nor s-NTX I were significantly (p < 0.001) associated with 3-year BMD changes at the lumbar spine and the femoral neck. Changes in s-CTX I, PICP and BALP were significantly associated with change in total proximal femur BMD. Changes in biochemical markers explain less than 8% of the BMD changes. The 3-month changes in BALP, PICP s-CTX I and s-NTX I were not significantly associated with fracture incidence.


CONCLUSIONS
Short-term changes in biochemical markers of bone formation are associated with future BMD changes in patients treated with strontium ranelate, suggesting a bone-forming activity of this treatment, but are not appropriate to monitor the efficacy of strontium ranelate at the individual level.
Bruyère
O
O
Department of Public Health, Epidemiology and Health Economics, CHU Sart-Tilman, University of Liège, Bât B23, 4000 Liège, Belgium. olivier.bruyere@ulg.ac.be
Collette
J
J
Rizzoli
R
R
Decock
C
C
Ortolani
S
S
Cormier
C
C
Detilleux
J
J
Reginster
J-Y
JY
D000368:Aged; D000369:Aged, 80 and over; D000469:Alkaline Phosphatase / Q000097:blood; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects* / Q000502:physiology; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D016723:Bone Remodeling / Q000187:drug effects* / Q000502:physiology; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D005500:Follow-Up Studies; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D009942:Organometallic Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D010446:Peptide Fragments / Q000097:blood; D011347:Procollagen / Q000097:blood; D016032:Randomized Controlled Trials as Topic; D016103:Spinal Fractures / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D013876:Thiophenes / Q000494:pharmacology / Q000627:therapeutic use*
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D009942:Organometallic Compounds; D010446:Peptide Fragments; D011347:Procollagen; D013876:Thiophenes; C042813:procollagen type I carboxy terminal peptide; C081587:strontium ranelate; D000469:Alkaline Phosphatase