Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.


Strontium Ranelate in the Treatment of Male Osteoporosis. One Year Results of a Placebo Controlled Study.

Kaufman1,  Jean-Marc, Audran2,  Maurice, Bianchi3,  Gerolamo, Boonen4,  Steven, Josse5,  Robert, Francis6,  Roger M., Goemaere1,  Stefan

Ghent University Hospital, Ghent, Belgium
Charité Campus Benjamin Franklin, Berlin, Germany
CHU Angers, Angers, France
Ospedale La Colletta, Arenzano-GE, Italy
Leuven University Hospital, Leuven, Belgium
St Michael's Hospital, Toronto
Institute for Ageing and Health, Newcastle, United Kingdom
Instituto Palacios, Madrid, Spain
Fundacion Jimenez Diaz, Madrid, Spain
Klinikum Leverkusen, University of Cologne, Cologne, Germany

Background/Purpose:

Male osteoporosis is increasingly recognised as a major public health issue. The efficacy and safety of strontium Ranelate (Sr Ran) have been established for treatment of post menopausal osteoporotic women. The male Osteoporosis study assessed the efficacy and safety of SrRan in men with primary osteoporosis.

Methods:

The study was a 2-year double-blind placebo-controlled randomised trial (SrRan 2g/day/placebo 2:1). Bone mineral density (BMD) at the lumbar and femoral sites was measured every 6 months. Primary endpoint was relative changes from baseline of lumbar BMD L2-L4 (LS BMD) at 1 year. An ITT analysis was applied.

Results:

Baseline characteristics were similar in both groups (mean ±SD): age: 73.1±6.1 vs 72.6±5.7 yrs; LS T-Score: - 2.7±0.9 vs – 2.4±1.2, femoral neck T-score: - 2.3±0.6 vs – 2.3±0.7, prevalent vertebral fractures and prevalent peripheral osteoporosis fracture = 28.2% vs 25.3% and 11.5% vs 10.3% respectively.

Over 1 year, LS BMD increased significantly in the SrRan group compared to placebo from baseline to endpoint, by 5.3%±0.75 (p<0.001); femoral neck BMD increased by 2.9%±0.62, (p<0.001). There was a decrease in bone resorption (estimate of adjusted means difference (SrRan-placebo) for s-CTX: –25.9%(7.86), p=0.0011) and a maintenance of bone formation (estimate of adjusted means difference for bALP:4.5%(3.0),NS). An improvement (i.e. score decrease) in both groups of the Quality of life was observed, more marked in the SrRan group (-0.16±0.6 vs. -0.07±0.5 in the placebo group,NS), particularly regarding 'pain interfering with patient sleep' (16.2% vs 5.1%, p=0.016).

Furthermore, the serum strontium levels and the magnitude of the increases in lumbar (6.38%±0.81) and femoral neck (3.19%±0.70) BMD at M12 in this male population, were similar to those previously observed in PMO women studies as shown in the table below:

Relative changes (M0–M12) versus placebo (%) Maleo N=243PMO studies N=6551Effects in Men versus Women
Lumbar spine BMD %E(SE) 95% CI p-value6.38% (0.81) [4.1,8.0] p<0.0017.04% (0.35) [6.7,7.4] p<0.001p-value1= 0.442
Femoral neck BMD %E(SE) 95% CI p-value3.19% (0.7) [1.8,4.6] p<0.0013.52% (0.14) [3.3,3.8] p<0.001p-value1= 0.655
E(SE): Estimate and Standard Error of the adjusted mean difference (S 12911 2g minus Placebo)
(1) p-value of the Student test
No new safety concern has been detected in this male population.

Conclusion:

In a male population at high risk of fractures, a marked increase in the mean lumbar L2-L4 and femoral neck BMD were observed, similar to that previously observed in women. Considering the present results in men and the previously established relationship between change in BMD and reduction in new vertebral and hip fractures risk with SrRan treatment in women, a similar anti-fracture efficacy is expected in men. Safety results did not reveal any unexpected adverse events in men exposed to SrRan.

To cite this abstract, please use the following information:
Kaufman, Jean-Marc, Audran, Maurice, Bianchi, Gerolamo, Boonen, Steven, Josse, Robert, Francis, Roger M., et al; Strontium Ranelate in the Treatment of Male Osteoporosis. One Year Results of a Placebo Controlled Study. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1104
DOI:

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