Between-Meal Risedronate Does Not Alter Bone Turnover in Nursing Home Residents

• Published in: Journal of the American Geriatrics Society (JAGS) Vol. 54; no. 5; pp. 790 - 795
• Main Authors: Agrawal, Sabina, Krueger, Diane C., Engelke, Jean A., Nest, Lori J., Krause, Peggy F., Drinka, Paul J., Binkley, Neil C.
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01-05-2006; Blackwell; Wiley Subscription Services, Inc
• Subjects: Aged; aging; Alkaline Phosphatase - blood; Biological and medical sciences; bisphosphonates; Bone Density Conservation Agents - administration & dosage; Bone Remodeling - drug effects; Bones; Calcium; Calcium - administration & dosage; Collagen Type I - blood; Dietary supplements; Diseases of the osteoarticular system; Double-Blind Method; Drug Administration Schedule; Drug therapy; Drug Therapy, Combination; Etidronic Acid - administration & dosage; Etidronic Acid - analogs & derivatives; Female; General aspects; Geriatrics; Humans; Male; Medical sciences; nursing home; Nursing Homes; Older people; osteoporosis; Osteoporosis. Osteomalacia. Paget disease; Peptides - blood; Risedronate Sodium; Vitamin D; Vitamin D - administration & dosage; Vitamin D - analogs & derivatives; Vitamin D - blood; Human; Long stay; Senescence; Nursing home for the aged; Ageing; Diseases of the osteoarticular system; Meal; Diphosphonic acid derivatives; Bisphosphonates; Care; Osteoarticular system; Osteoporosis; Gerontology; Vitamin D; Risedronic acid; Turnover; Resident; Bone; aging; Homes for the aged; Nursing home; Elderly; Geriatrics
• ISSN: 0002-8614; 1532-5415
• DOI: 10.1111/j.1532-5415.2006.00696.x

OBJECTIVES: To assess the effect of between‐meal weekly risedronate and daily calcium 630 mg and vitamin D 400 IU on bone turnover markers.
DESIGN: Randomized,double‐blind,placebo‐controlled trial.
SETTING: Skilled nursing home (NH).
PARTICIPANTS: Sixty skilled‐NH residents (46 men, 14 women), mean age±standard deviation of 76±6, were randomized to receive risedronate 30 mg (n=31) or matching placebo (n=29) once weekly for 12 weeks. All received 315 mg calcium with 200 IU vitamin D twice daily.
MEASUREMENTS: Bone‐specific alkaline phosphatase (BSAP), N‐telopeptide of type 1 collagen (NTx), 25‐hydroxyvitamin D (25OHD), and parathyroid hormone were measured at baseline and 6 and 12 weeks.
RESULTS: Risedronate reduced BSAP significantly more than placebo (P<.05) at 6 weeks but not at 12 weeks; no treatment effect on serum NTx was observed. Defining hypovitaminosis D as a serum 25OHD concentration below 32 ng/mL, 50 of 53 (94%) study participants were low at baseline (mean 25OHD 19 ng/mL). Vitamin D levels remained insufficient in 74% of participants after 12 weeks.
CONCLUSION: In this NH population, weekly risedronate administered using a between‐meal dosing schedule reduced serum BSAP at 6 weeks of treatment; this effect was not observed at 12 weeks. The overall lack of change in bone turnover markers suggests that this risedronate dose and schedule would not be expected to increase bone density or reduce fracture risk in this population. Hypovitaminosis D was common and not reliably corrected by 400 IU of vitamin D daily. Despite an extremely high osteoporotic fracture risk in NH residents, additional study is required to determine under which conditions pharmacological treatment is efficacious in this population and define approaches that assure vitamin D repletion.