Teriparatide in postmenopausal women with osteoporosis and mild or moderate renal impairment

• Published in: Osteoporosis international 2007, Vol.18 (1), p.59-68
• Main Authors: MILLER, P. D, SCHWARTZ, E. N, CHEN, P, MISURSKI, D. A, KREGE, J. H
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Aging; Biological and medical sciences; Bone Density - drug effects; Bone Density Conservation Agents - adverse effects; Bone Density Conservation Agents - therapeutic use; Diseases of the osteoarticular system; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Female; Fractures, Bone - etiology; Fractures, Bone - prevention & control; Glomerular Filtration Rate; Humans; Hypercalcemia - chemically induced; Hyperuricemia - chemically induced; Investigative techniques, diagnostic techniques (general aspects); Kidney - physiopathology; Kidney diseases; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Nephropathies. Renovascular diseases. Renal failure; Osteoarticular system. Muscles; Osteoporosis; Osteoporosis, Postmenopausal - blood; Osteoporosis, Postmenopausal - complications; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis. Osteomalacia. Paget disease; Peptide Fragments - blood; Procollagen - blood; Radiodiagnosis. Nmr imagery. Nmr spectrometry; Renal failure; Renal Insufficiency - blood; Renal Insufficiency - complications; Renal Insufficiency - physiopathology; Risk factors; Teriparatide - adverse effects; Teriparatide - therapeutic use; Womens health
• ISSN: 0937-941X; 1433-2965
• DOI: 10.1007/s00198-006-0189-8

The prevalence of both osteoporosis and renal impairment increases with age. Using data from the Fracture Prevention Trial, the safety and efficacy of teriparatide [rhPTH(1-34)] in postmenopausal women with osteoporosis and renal impairment were explored. Patients were required to have serum creatinine concentrations < or =2.0 mg/dl and normal serum parathyroid hormone (PTH) concentrations and were randomized to receive daily subcutaneous injections of placebo or teriparatide 20 or 40 mcg/day. Glomerular filtration rate (GFR) was estimated using the Cockcroft-Gault equation. Patients were defined from baseline assessments to have normal (GFR > or =80 ml/min), mildly impaired (GFR 50-79 ml/min), or moderately impaired (GFR 30-49 ml/min) renal function for bone mineral density (BMD) and amino-terminal extension peptide of procollagen type 1 (PINP) analyses, and normal (GFR > or =80 ml/min) or impaired (GFR 0.05). Similarly, teriparatide-mediated vertebral and nonvertebral fracture risk reductions were similar and did not differ significantly between patients with normal or impaired renal function (treatment-by-subgroup interactions p>0.05). The incidences of treatment-emergent and renal-related adverse events were consistent across treatment assignment in the normal, mildly impaired, and moderately impaired renal function subgroups. Teriparatide induced changes in mean GFR were unaffected by baseline renal function (treatment-by-renal function interaction p>0.05 for normal, mildly impaired, or moderately impaired subgroups). Patients in all renal function categories treated with teriparatide 20 or 40 mcg had an increased incidence of 4-6-h postdose serum calcium >10.6 mg/dl (the upper limit of normal) versus placebo; however, teriparatide 20 mcg/day was not associated with significantly increased incidence of 4-6-h postdose serum calcium >11 mg/dl in any renal function category. Teriparatide therapy was associated with increased incidence of elev