title: Effects of neridronate treatment in elderly women with osteoporosis.
abstract: 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.
authors.affiliation: Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples, Italy.
authors.forename: T
authors.initials: T
authors.lastname: Cascella
authors.forename: T
authors.initials: T
authors.lastname: Musella
authors.forename: F
authors.initials: F
authors.lastname: Orio
authors.forename: S
authors.initials: S
authors.lastname: Palomba
authors.forename: G
authors.initials: G
authors.lastname: Bifulco
authors.forename: C
authors.initials: C
authors.lastname: Nappi
authors.forename: G
authors.initials: G
authors.lastname: Lombardi
authors.forename: A
authors.initials: A
authors.lastname: Colao
authors.forename: L
authors.initials: L
authors.lastname: Tauchmanova
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D004164:Diphosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy* / Q000523:psychology; D010865:Pilot Projects; D011788:Quality of Life
chemical_list: D004164:Diphosphonates; C053389:6-amino-1-hydroxyhexane-1,1-diphosphonate