Effects of denosumab on bone mineral density and bone turnover in patients with
rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates.
Author(s): Dore RK, Cohen SB, Lane NE, Palmer W, Shergy W, Zhou L, Wang H, Tsuji W, Newmark
R; Denosumab RA Study Group.
Collaborators: Atkins C, Beaulieu A, Bell M, Bookbinder S, Brodsky A, Deodhar A,
Divittorio G, Fishman A, Grant E, Grimmett B, Haraoui B, Huffstutter J, Hurd E,
Kaell A, Kavanaugh A, Kay J, Keystone E, Khraishi M, Kohen M, Iannini M, Mandel
D, McKendry R, Mease P, Moreland L, Newell S, Peterfy C, Poiley J, Ratiner B,
Ritchlin C, Schechtman J, Schiff M, Sharp J, Silverman A, Sultany G, Tannenbaum
H, Trapp R, Valen P, Zummer M.
Affiliation(s): Robin K Dore Inc, Tustin, CA, USA. rkdmail@sbcglobal.net
Publication date & source: 2010, Ann Rheum Dis. , 69(5):872-5
OBJECTIVES: To report results of subgroup analyses of bone mineral density (BMD)
and bone turnover markers from a randomised, double-blind, placebo-controlled,
phase II study of denosumab, an investigational RANKL inhibitor, in patients with
rheumatoid arthritis (RA) concurrently receiving treatment with bisphosphonates
or glucocorticoids.
METHODS: Patients received subcutaneous placebo (n=75), denosumab 60 mg (n=71) or
denosumab 180 mg (n=72) at baseline and 6 months. Assessments included dual x-ray
absorptiometry scans of the lumbar spine and hip, and determination of levels of
serum type I C-telopeptide (sCTx-I) and serum procollagen 1N-terminal peptide
(P1NP).
RESULTS: Denosumab treatment increased mean lumbar spine and hip BMD and reduced
sCTx-I and P1NP compared with placebo through 12 months, regardless of baseline
BMD or marker levels or concomitant bisphosphonate or glucocorticoid use.
CONCLUSIONS: This study extends evidence that denosumab increases BMD and reduces
bone turnover in patients with RA and may provide a new therapeutic option for
reducing systemic bone loss in patients with RA.
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