Update on the role of bone turnover markers in the diagnosis and management of osteoporosis: a consensus paper from The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), International

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Abstract

[Indexed for MEDLINE] Conflict of interest statement: Declarations. Conflict of interest: H.P.B.: No conflict of interest; S.V.: No conflict of interest; I.T.: No conflict of interest; G.K.: No conflict of interest; G.L.: Received speaker fee from SNIBE; N.R.J.: Received bone turnover marker assays free of charge for research from ROCHE, IDS and DiaSorin for research purposes; R.P.: No conflict of interest; M.M.: No conflict of interest; R.C.: Holds patents of 2 biomarkers of musculoskeletal diseases; M.Hiligsmann: Received research grants (paid to institution) from RADIUS HEALTH, and ANGELINI PHARMA, lecture fees from IBSA (paid to institution) and MYLAN PHARMACEUTICALS, and was grant advisor for PFIZER (paid to institution); M.Haarhaus: No conflict of interest; P.E.: Received research grants (paid to institution) from VIFOR CSL; H.S.J.: Received travel support from ABIOGEN PHARMA; M.Hermann: No conflict of interest; J-M.K.: No conflict of interest; P.C.: No conflict of interest; S.T.: No conflict of interest; N.A-D.: No conflict of interest; S.S.: No conflict of interest; M.S.A.: No conflict of interest; S.O.: No conflict of interest; M.C.P.Y.: No conflict of interest; R.M.: No conflict of interest; A.L.: No conflict of interest; M.M.C.d.S.R: No conflict of interest; L.Z.: No conflict of interest; N.B: No conflict of interest; E.M.: No conflict of interest; N.C.H: Received consultancy, lecture fees, honoraria, grant funding from ALLIANCE FOR BETTER BONE HEALTH, AMGEN, MSD, ELI LILLY, RADIUS HEALTH, SERVIER, SHIRE, UCB, CONSILIENT HEALTHCARE, KYOWA KIRIN, THERAMEX and INTERNIS PHARMA; R.P.R: No conflict of interest; M.F.: Received consultancy fees from ABIOGEN, AMGEN, VIFOR, OMEGA PHARMA; C.T.: No conflict of interest, the views expressed in this article are the personal views of the author and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies by which the author is employed or affiliated; J.A.K.: No conflict of interest; R.R.: No conflict of interest; JY.R.: Stakeholder of SarQoL® whereas he never received any financial or non-financial compensation for this activity, received consultancy fees from IBSA, PROMEDIUS, VIATRIS, REJUVENATE BIOMED, CELLTRION, AGNOVOS, THERAMEX and VERSANIS BIO, CHUGAI, member of the Speakers Bureau for IBSA, RADIUS HEALTH, VIATRIS, AGNOVOS and TRB CHEMEDICA, received research grants (through Institutions) from IBSA, RADIUS HEALTH, ECHOLIGHT, VIATRIS, THERAMEX and TRB CHEMEDICA; K.M.: Received free of charge reagents from ROCHE, SNIBE and IDS for research purposes; E.C.: Consultant for IDS, DIASORIN, FUJIREBIO, NITTOBO and MENARINI. 7. Lancet. 2015 Sep 19;386(9999):1147-55. doi: 10.1016/S0140-6736(15)61120-5. Epub 2015 Jul 2. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial. Leder BZ(1), Tsai JN(2), Uihlein AV(2), Wallace PM(2), Lee H(3), Neer RM(2), Burnett-Bowie SA(2). Author information: (1)Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: bzleder@partners.org. (2)Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA. (3)Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA. Comment in Lancet. 2015 Sep 19;386(9999):1116-8. doi: 10.1016/S0140-6736(15)61175-8. Nat Rev Endocrinol. 2015 Oct;11(10):570-2. doi: 10.1038/nrendo.2015.134. BACKGROUND: Unlike most chronic diseases, osteoporosis treatments are generally limited to a single drug at a fixed dose and frequency. Nonetheless, no approved therapy is able to restore skeletal integrity in most osteoporotic patients and the long-term use of osteoporosis drugs is controversial. Thus, many patients are treated with the sequential use of two or more therapies. The DATA study showed that combined teriparatide and denosumab increased bone mineral density more than either drug alone. Discontinuing teriparatide and denosumab, however, results in rapidly declining bone mineral density. In this DATA-Switch study, we aimed to assess the changes in bone mineral density in postmenopausal osteoporotic women who transitioned between treatments. METHODS: This randomised controlled trial (DATA-Switch) is a preplanned extension of the denosumab and teriparatide administration study (DATA), in which 94 postmenopausal osteoporotic women were randomly assigned to receive 24 months of teriparatide (20 mg daily), denosumab (60 mg every 6 months), or both drugs. In DATA-Switch, women originally assigned to teriparatide received denosumab (teriparatide to denosumab group), those originally assigned to denosumab received teriparatide (denosumab to teriparatide group), and those originally assigned to both received an additional 24 months of denosumab alone (combination to denosumab group). Bone mineral density at the spine, hip, and wrist were measured 6 months, 12 months, 18 months, and 24 months after the drug transitions as were biochemical markers of bone turnover. The primary endpoint was the percent change in posterior-anterior spine bone mineral density over 4 years. Between-group changes were assessed by one-way analysis of variance in our modified intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00926380. FINDINGS: Between Sept 27, 2011, and Jan 28, 2013, eligible women from the DATA study were enrolled into DATA-Switch. Of 83 potential enrollees from the DATA study, 77 completed at least one post-baseline visit. After 48 months, the primary outcome of mean spine bone mineral density increased by 18·3% (95% CI 14·9-21·8) in 27 women in the teriparatide to denosumab group, 14·0% (10·9-17·2) in 27 women the denosumab to teriparatide group, and 16·0% (14·0-18·0) in 23 women in the combination to denosumab group, although this increase did not differ significantly between groups (for between-group comparisons, p=0·13 for the teriparatide to denosumab group vs the denosumab to teriparatide group, p=0·30 for the teriparatide to denosumab group vs the combination to denosumab group, and p=0·41 for the denosumab to teriparatide group vs the combination to denosumab group). For the bone mineral density secondary outcomes, total hip bone mineral density increased more in the teriparatide to denosumab group (6·6% [95% CI 5·3-7·9]) than in the denosumab to teriparatide group (2·8% [1·3-4·2], p=0·0002), but had the greatest increase in the combination to denosumab group (8·6% [7·1-10·0]; p=0·0446 vs the teriparatide to denosumab group, p