Statins have additive effects to vertebral bone mineral density in combination with risedronate in hypercholesterolemic postmenopausal women Hamit Alper Tanriverdi a, * , Aykut Barut a , Selda Sarikaya b a Menopause Clinic, Department of Obstetrics and Gynecology, Karaelmas University Medical School, 67600 Kozlu, Zonguldak, Turkey b Department of Physical Medicine and Rehabilitation, Karaelmas University Medical School, 67600 Kozlu, Zonguldak, Turkey Received 20 February 2004; received in revised form 26 July 2004; accepted 19 August 2004 Abstract Background: Recent data suggest that statins used in the treatment of hypercholesterolaemia decrease fracture risk. In this study, we aimed to investigate prospectively whether statins have an additive effect to bisphosphonates (risedronate) according to the primary hypothesis that the addition of atorvastatin to risedronate would produce an increase, from baseline, in lumbar vertebrae and total hip BMD that was greater than that observed with risedronate alone. Methods: A total of 120 hypercholesterolaemic postmenopausal women with osteoporosis or osteopenia were randomized to receive risedronate (5 mg/day) or risedronate (5 mg/day) plus atorvastatin (20 mg/day). Changes in bone mineral density in the lumbar spine and hip, and serum lipid and glucose metabolism changes were assessed. Results: Compared with risedronate alone, at 6 months, risedronate plus atorvastatin produced significantly greater increases in the bone mineral density of the lumbar spine (1.58% versus 0.75%, p < 0.05). We found no difference after therapy in BMD of the total hip (1.2% versus 1.1%). Risedronate plus atorvastatin therapy had favorable effects on the serum lipid profile: LDL and total cholesterol. Serum fasting glucose and HbA1c levels were not affected during the treatments. Conclusion: Statins have modest additive effects to bisphosphonates in improving lumbar spine bone mineral density in hypercholester- olaemic postmenopausal women with established osteoporosis–osteopenia. A long-term study with adequate sample size is necessary to assess the effects of statins – in combination or alone – on the bones and prevention of fractures. # 2004 Elsevier Ireland Ltd. All rights reserved. Keywords: Atorvastatin; Bone mineral density; Hypercholesterolaemia; Risedronate; Postmenopause; Osteoporosis 1. Introduction Osteoporosis is a common and significant health problem affecting mostly postmenopausal women [1]. It is char- acterized by a deterioration of the skeleton leading to a higher incidence of bone fractures. However, the availability of effective diagnostic procedures, such as bone mineral densitometry determinations, and the existence of an armamentarium of relatively effective drugs have made it possible to establish interventions that prevent the most severe complications of advanced osteoporosis. Estrogens, bisphosphonates, calcitonin and raloxifene are widely used therapeutic alternatives for prevention and treatment of osteoporosis. In controlled, prospective clinical trials, subjects receiving these one-agent therapies had an increase in bone mineral density (BMD) of approximately 2–8% at the lumbar spine and 2–3% at the femoral neck after 12 months of therapy [2]. Bisphosphonates primarily reduce bone turnover [3], mainly by reducing the activation of new remodeling units within the skeleton [4], inhibition of bone resorption by osteoclasts [2]. Recent data suggest that also statins used in the treatment of hypercholesterolaemia decrease fracture risk [5–7]. Statins, which inhibit 3-hydroxy-3-methylglutarylcoenzyme A (HMG-CoA) reductase, are shown to increase bone www.elsevier.com/locate/ejogrb European Journal of Obstetrics & Gynecology and Reproductive Biology 120 (2005) 63–68 * Corresponding author. Tel.: +90 372 2610135; fax: +90 372 2610155. E-mail address: tanriverdi@artemisonline.net (H.A. Tanriverdi). 0301-2115/$ – see front matter # 2004 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ejogrb.2004.08.007