PMID- 27026335 OWN - NLM STAT- MEDLINE DCOM- 20180322 LR - 20220129 IS - 1433-2965 (Electronic) IS - 0937-941X (Linking) VI - 27 IP - 8 DP - 2016 Aug TI - Response of bone turnover markers to raloxifene treatment in postmenopausal women with osteopenia. PG - 2585-92 LID - 10.1007/s00198-016-3573-z [doi] AB - We used two methods of identifying women who reached the target for raloxifene treatment with bone turnover markers. Both approaches identified women that responded to treatment but did not fully agree and may be complementary. INTRODUCTION: The change in bone turnover markers (BTMs) in response to osteoporosis therapy can be assessed by a decrease beyond the least significant change (LSC) or below the mean of the reference interval (RI). We compared the performance of these two approaches in women treated with raloxifene. METHODS: Fifty postmenopausal osteopenic women (age 51-72 years) were randomised to raloxifene or no treatment for 2 years. Blood samples were collected for the measurement of BTM. The LSC for each marker was calculated from the untreated women and the RI obtained from healthy premenopausal women (age 35-40 years). Bone mineral density (BMD) was measured at the spine and hip. RESULTS: There was a decrease in BTM in response to raloxifene treatment, percentage change at 12 weeks: C terminal telopeptide of type I collagen (CTX) -39 % (95 % CI -48 to -28) and N terminal propeptide of type I procollagen (PINP) -32 % (95 % CI -40 to -23) P < 0.001. The proportion of women classified as responding to treatment using LSC at 12 weeks was as follows: CTX 38 % and PINP 52 % and at 48 weeks CTX 60 % and PINP 65 %. For the RI approach, the proportion of women classified as responding to treatment at 12 weeks was CTX and PINP 38 % and at 48 weeks CTX 40 % and PINP 45 %. There was a significant difference in the change in spine BMD in the raloxifene-treated group compared to the no-treatment group at week 48: difference 0.031 g/cm(2) (95 % CI 0.016 to 0.046, P < 0.001). CONCLUSIONS: The two approaches identified women that reached the target for treatment using BTM. Both LSC and RI criteria appear useful in identifying treatment response, but the two approaches do not fully overlap and may be complementary. FAU - Naylor, K E AU - Naylor KE AD - Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK. k.e.naylor@sheffield.ac.uk. FAU - Jacques, R M AU - Jacques RM AD - School of Health and Related Research, University of Sheffield, Sheffield, UK. FAU - Peel, N F A AU - Peel NF AD - Metabolic Bone Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital Sheffield, Sheffield, UK. FAU - Gossiel, F AU - Gossiel F AD - Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK. FAU - Eastell, R AU - Eastell R AD - Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK. LA - eng GR - MR/K006312/1/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Randomized Controlled Trial DEP - 20160330 PL - England TA - Osteoporos Int JT - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JID - 9100105 RN - 0 (Biomarkers) RN - 0 (Collagen Type I) RN - 0 (Procollagen) RN - 4F86W47BR6 (Raloxifene Hydrochloride) SB - IM MH - Adult MH - Aged MH - Biomarkers/blood MH - *Bone Density MH - Bone Diseases, Metabolic/*drug therapy MH - *Bone Remodeling MH - Collagen Type I/blood MH - Female MH - Humans MH - Middle Aged MH - Osteoporosis, Postmenopausal/*drug therapy MH - Postmenopause MH - Procollagen/blood MH - Raloxifene Hydrochloride/*therapeutic use OTO - NOTNLM OT - Bone markers OT - Bone resorption OT - Osteopenia OT - Raloxifene EDAT- 2016/03/31 06:00 MHDA- 2018/03/23 06:00 CRDT- 2016/03/31 06:00 PHST- 2015/11/25 00:00 [received] PHST- 2016/03/14 00:00 [accepted] PHST- 2016/03/31 06:00 [entrez] PHST- 2016/03/31 06:00 [pubmed] PHST- 2018/03/23 06:00 [medline] AID - 10.1007/s00198-016-3573-z [pii] AID - 10.1007/s00198-016-3573-z [doi] PST - ppublish SO - Osteoporos Int. 2016 Aug;27(8):2585-92. doi: 10.1007/s00198-016-3573-z. Epub 2016 Mar 30.