title: Teriparatide is safe and effectively increases bone biomarkers in institutionalized individuals with osteoporosis.
abstract: Institutionalized adults with severe developmental disabilities have a high rate of minimal trauma and appendicular fracture. There is little information about osteoporosis treatment in this population. In this efficacy and safety study, men and women with severe developmental disabilities and osteoporosis received 20 mcg teriparatide subcutaneously daily for 18-24 months. Markers of bone formation [procollagen type 1 intact N-terminal propeptide (P1NP)] and resorption [C-telopeptide (CTx)] were measured at three-month intervals. Serum calcium was measured at two-week intervals for 12 weeks and thereafter at three-month intervals. Twenty-seven individuals received at least one injection. The incidence of hypercalcemia was 11.1% but was persistent and led to medication discontinuation in only one participant. Biomarkers of bone formation increased rapidly, doubling by three months. At 12 months, P1NP and CTx remained elevated from baseline; P1NP had risen from 66.95 +/- 83.71 microg/l (mean +/- SD) to 142.42 +/- 113.85 microg/l (P = 0.05), and CTx had increased from 0.377 +/- 0.253 to 1.016 +/- 1.048 ng/ml (P = 0.01). The majority of participants had an increase in P1NP of over 10 microg/l. In conclusion, teriparatide is safe and effective in developmentally disabled institutionalized adults. Serial calcium measurements are warranted, particularly during the first three months of therapy.
authors.affiliation: Department of Medicine, The University of Tennessee Health Science Center, Memphis, TN, USA. kryder@utmem.edu
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Ryder
authors.forename: S Bobo
authors.initials: SB
authors.lastname: Tanner
authors.forename: Laura
authors.initials: L
authors.lastname: Carbone
authors.forename: John E
authors.initials: JE
authors.lastname: Williams
authors.forename: Henry M
authors.initials: HM
authors.lastname: Taylor
authors.forename: Andrew
authors.initials: A
authors.lastname: Bush
authors.forename: Victorina
authors.initials: V
authors.lastname: Pintea
authors.forename: Mitchell A
authors.initials: MA
authors.lastname: Watsky
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001862:Bone Resorption; D001842:Bone and Bones / Q000187:drug effects*; D002118:Calcium / Q000097:blood; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D006934:Hypercalcemia / Q000139:chemically induced / Q000517:prevention & control; D018476:Hypokinesia / Q000150:complications; D007279:Injections, Subcutaneous; D007326:Institutionalization; D008297:Male; D008875:Middle Aged; D010012:Osteogenesis / Q000187:drug effects; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy*; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D019989:Persons with Intellectual Disabilities; D019379:Teriparatide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D019379:Teriparatide; D002118:Calcium