Use of recombinant human parathyroid hormone(1-84) in patients with postmenopausal osteoporosis: A prospective, open-label, single-arm, multicentre, observational cohort study of the effects of treatment on quality of life and pain -the propose study

Clinical Drug Investigation

Volumn 31, Issue 2, 2011, Pages 87-99

  Möricke, Rüdiger ^a   Rettig, Klaus ^b   Bethke, Thomas D ^c  

^a Institut Fr Prventive Medizin and Klinische Forschung GbR   (Germany)

^b Bureau of Evaluation and Quality Assurance in Medicine   (Germany)

^c Nycomed GmbH   (Germany)

Author keywords

Osteoporosis, treatment; Pain; Parathyroid hormone, therapeutic use; Quality of life

Indexed keywords

ALENDRONIC ACID; CALCIUM CARBONATE; COLECALCIFEROL; OPIATE; RALOXIFENE; RECOMBINANT PARATHYROID HORMONE; RISEDRONIC ACID; STRONTIUM RANELATE;

ADULT; AGED; ANALGESIA; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEALTH SURVEY; HEART BEAT; HEART INFARCTION; HUMAN; HYPERCALCEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NAUSEA AND VOMITING; PAIN; PAIN ASSESSMENT; PATIENT COMPLIANCE; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; QUALITY OF LIFE; SIDE EFFECT; TASK PERFORMANCE; UNSPECIFIED SIDE EFFECT; VISUAL ANALOG SCALE; VOMITING;

AGED; AGED, 80 AND OVER; BONE DENSITY CONSERVATION AGENTS; FEMALE; HUMANS; HYPERCALCEMIA; INJECTIONS, SUBCUTANEOUS; MIDDLE AGED; NAUSEA; OSTEOPOROSIS, POSTMENOPAUSAL; PAIN; PARATHYROID HORMONE; PROSPECTIVE STUDIES; QUALITY OF LIFE; RECOMBINANT PROTEINS; VOMITING;

EID: 78650264647     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11538880-000000000-00000     Document Type: Article

References (21)

1. ONeill TW, Roy DK. How many people develop fractures with what outcome? Best Pract Res Clin Rheumatol 2005; 19 (6): 879-95
2. Raisz LG. Pathogenesis of osteoporosis: concepts, conflicts, and prospects. J Clin Invest 2005; 115 (12): 3318-25
3. Sambrook P, Cooper C. Osteoporosis. Lancet 2006; 367 (9527): 2010-8 (Pubitemid 43867702)
4. Port L, Center J, Briffa NK, et al. Osteoporotic fracture: missed opportunity for intervention. Osteoporos Int 2003; 14 (9): 780-4 (Pubitemid 37295842)
5. Khan MN, Khan AA. Cancer treatment-related bone loss: a review and synthesis of the literature. Curr Oncol 2008; 15 Suppl. 1: S30-40
6. Cranney A, Papaioannou A, Zytaruk N, et al. Parathyroid hormone for the treatment of osteoporosis: a systematic review. CMAJ 2006; 175 (1): 52-9 (Pubitemid 44065193)
7. Nycomed Danmark ApS. Summary of product characteristics Preotact-. Roskilde, 2006
8. Salaffi F, Cimmino MA, Malavolta N, et al. The burden of prevalent fractures on health-related quality of life in postmenopausal women with osteoporosis: the IMOF study. J Rheumatol 2007; 34 (7): 1551-60 (Pubitemid 47067994)
9. Suzuki N, Ogikubo O, Hansson T. The course of the acute vertebral body fragility fracture: its effect on pain, disability and quality of life during 12 months. Eur Spine J 2008; 17 (10): 1380-90
10. Lips P, Cooper C, Agnusdei D, et al. Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis. Osteoporos Int 1999; 10 (2): 150-60
11. Bianchi ML, Orsini MR, Saraifoger S, et al. Quality of life in post-menopausal osteoporosis. Health Qual Life Outcomes 2005; 3: 78 (Pubitemid 41800136)
12. WHO (World Health Organization). International statistical classification of diseases, 10th revision (ICD-10) [online]. Available from URL: http://www.who.int/classifica tions/apps/icd/ icd10online/2008 [Accessed 2010 Jul 1]
13. Runge M, Rittweger J, Russo CR, et al. Is muscle power output a key factor in the age-related decline in physical performance? A comparison of muscle cross section, chairrising test and jumping power. Clin Physiol Funct Imaging 2004; 24 (6): 335-40 (Pubitemid 39529870)
14. Lau AN, Ali SH, Sawka AM, et al. Improvement in healthrelated quality of life in osteoporosis patients treated with teriparatide. BMC Musculoskelet Disord 2008; 9: 151
15. Nevitt MC, Chen P, Dore RK, et al. Reduced risk of back pain following teriparatide treatment: a meta-analysis. Osteoporos Int 2006; 17 (2): 273-80 (Pubitemid 43053592)
16. Adami S. Full length parathyroid hormone, PTH(1-84), for the treatment of severe osteoporosis in postmenopausal women. Curr Med Res Opin 2008; 24: 3259-74
17. Greenspan SL, BoneHG, EttingerMP, et al. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med 2007; 146 (5): 326-39
18. Hodsman AB, Hanley DA, Ettinger MP, et al. Efficacy and safety of human parathyroid hormone-(1-84) in increasing bone mineral density in postmenopausal osteoporosis. J Clin Endocrinol Metab 2003; 88 (11): 5212-20
19. Black DM, Bilezikian JP, Ensrud KE, et al. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med 2005; 353 (6): 555-65
20. Lindsay R, Miller P, Pohl G, et al. Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis. Osteoporos Int 2009; 20 (6): 943-8
21. Marquis P, Roux C, de la Loge C, et al. Strontium ranelate prevents quality of life impairment in post-menopausal women with established vertebral osteoporosis. Osteoporos Int 2008; 19 (4): 503-10