Osteoporosis is a common disorder, especially among elderly post-menopausal women. Elderly women are often affected by co-morbidities, impaired gastrointestinal function and reduced mobility; therefore, the treatment strategy for their
osteoporosis can be difficult. In this randomized pilot study, we have investigated the effects of a 12-month treatment with
neridronate on bone mineral density (BMD), bone turnover markers and quality of life (QoL). The study included 40 women (age, 65-80 yr; post-menopausal period, >15yr) from a single
osteoporosis centre. Twenty women received a monthly im injection of 25 mg of
neridronate associated with a daily dose of 500 mg of
calcium and 400 U of
vitamin D. Twenty women received
calcium plus
vitamin D supplements alone. Changes in BMD at the lumbar spine and femoral neck were measured by dual energy X-ray absorptiometry. Serum
type I collagen C-telopeptide (sCTX), urinary free-
deoxypyridinoline (ufDPD), bone
alkaline phosphatase (ALP) and serum
osteocalcin levels were determined. For the QoL assessment, the Italian version of the SF-36 test was administrated. Spine and hip BMD rose by 6.6 +/- 3 and 4.2 +/- 2.3%, respectively (p < 0.05), after 12 months of
neridronate treatment. Markers of skeletal turnover significantly fell already after 3 months of
neridronate treatment and decreased progressively thereafter within 12 months. The mean decrease at 12 months ranged from 38 +/- 11% for sCTX to 25.2 +/- 15% for ufDPD (p < 0.001, all). The mean improvement in QoL in the treated group was 45.7% for bodily
pain, 37.5% for general health perception, 23.1% for vitality, 18% for emotional role functioning and 12% for physical role functioning. The changes observed in BMD, turnover markers and QoL in the untreated group were ns. The intermittent
neridronate administration was easily manageable and well tolerated. In conclusion,
neridronate currently represents a valid option for the treatment of
osteoporosis, since it helps just as much as oral BPs in the improvement of BMD and in particular conditions it can be even more effective.