Key References

Matter 1A – Indirect data comparison

Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of aledronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348: 1535-41.

Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997; 50: 683-91.

Caldwell DM, Ades AE, Higgins JPT. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ 2005; 331: 897-900.

Delmas PD, Genant HK, Crans GG, Stock JL, Wong M, Siris E. Severity of prevalent vertebral fractures and the risk of subsequent vertebral and nonvertebral fractures: results from the MORE trial. Bone 2003; 33: 522-32.

Ensrud KE, Black DM, Palermo LMS, et al. Treatment with aledronate prevents fractures in women at highest risk: results from the Fracture Intervention Trial. Arch Int Med 1997; 157: 2617-24.

Lunt M, O’Neill TW, Felsenberg D et al. Characteristics of a prevalent vertebral deformity predict subsequent vertebral fracture: results from the European Prospective Osteoporosis Study (EPOS). Bone 2003; 33: 505-13.

Neer RM, Arnaud CD, Zanchetta JR et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001; 344: 1434-41.

Nevitt MC, Chen P, Dore RK et al. Reduced risk of back pain following teriparatide treatment: a meta-analysis. Osteoporosis International; published online: 2 September 2005 (accessed July 10 2006).

Song F, Altman DG, Glenny A-M, Deeks JJ. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ 2003; 326: 472-6.

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Matter 1B – Subgroup analysis

Assman SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000; 355: 1064-69.

Gallagher JC, Genant HK, Crans GG, Vargus SJ, Krege JH. Teriparatide Reduces the Fracture Risk Associated with Increasing Number and Severity of Osteoporotic Fractures. J Clin Endocrinol Metab 2005; 90(3): 1583-7.

Lagakos SW. The challenge of Subgroup Analyses-Reporting without Distorting. N Engl J Med 2006; 354: 1667-9.

Oxman AD, Guyatt GH. A consumer’s guide to subgroup analyses. Ann Intern Med 1992; 116: 78-84.

Parker AB, Naylor CD. Subgroups, treatment effects, and baseline risks: some lessons from major cardiovascular trials. Am Heart J 2000; 139: 952-61.

Pfeffer MA, Jarcho JA. The Charisma of Subgroups and the Subgroups of CHARISMA. N Engl J Med 2006; 354: 1744-6.

Rothwell PM. Treating Individuals 2. Subgroup analysis in randomized controlled trials: importance, indications, and interpretation. Lancet 2005; 365: 176-86.

Scott IA, Greenberg PB. Cautionary tales in the clinical interpretation of therapeutic trial reports. Int Med J 2005; 35: 611-21.

Yusif S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266: 93-8.

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Matter 2 – Biological plausibility

Altman DG, Bland JM. Statistics Notes Interactions revisited: the difference between two estimates. BMJ 2003; 326: 219.

Horwitz M, Stewart A, Greenspan SL. Sequential parathyroid hormone/aledronate therapy for osteoporosis-robbing Peter to pay Paul? J Clin Endocrinol Metab 2000; 85: 2127-8.

Jiang Y, Zhao JJ, Mitlak BH, Wang O, Genant HK, Eriksen EF. Recombinant Human Parathyroid Hormone (1-34) [Teriparatide] Improves both Cortical and Cancellous Bone Structure. J Bone Miner Res 2003; 18: 1932-41.

Klotzbeucher CM, Ross PD, Landsman PB, Abbott 3rd TA, Berger M. Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Min Res 2000; 15: 721-39.

Parkinson IH, Fazzalari NL. Interrelationships Between Structural Parameters of Cancellous Bone Reveal Accelerated Structural Change at Low Bone Volume. J Bone Min Res 2003; 18: 2200-05.

Zanchetta JR, Bogado CE, Ferretti JL, Wang O, Wilson MG, Sato M, Gaich GA, Dalsky GP, Myers SL. Effects of Teriparatide [Recombinant Human Parathyroid Hormone (1-34)] on Cortical Bone in Postmenopausal Women with Osteoporosis. J Bone Min Res 2003; 18: 539-43.

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Matter 3 – Validity of continued use of Utilities

Armstrong K, Chen TM, Albert D, Randall TC, Schwartz JS. Cost-effectiveness of ralozafine and hormone replacement therapy in postmenopausal women: impact on breast cancer risk. Obstetrics and Gynaecology. 2001;98,6:996-1003.

Commonwealth Department of Health and Ageing. Draft for Consultation July 2006. Guidelines for the Pharmaceutical Industry on preparation of submissions to the pharmaceutical Benefits Advisory Committee. Including major submissions involving economic analyses.
URL:http://www1.health.gov.au/internet/main/publishing.nsf/Content/pbac_guidelines (accessed 11th August 2006)

Commonwealth Department of Health and Ageing. Guidelines for the Pharmaceutical Industry on preparation of submissions to the pharmaceutical Benefits Advisory Committee. Including major submissions involving economic analyses. September 2002. (Section 3.5 of submission)

Commonwealth Department of Health and Ageing. Guidelines for the Pharmaceutical Industry on preparation of submissions to the pharmaceutical Benefits Advisory Committee. Including major submissions involving economic analyses. September 2002. (Appendix H of submission)

Coyle D, Cranney A, Lee KM, Welch V, Tugwell P. Cost-effectiveness of nasal calcitonin in postmenopausal women: use of Cochrane Collaboration methods for meta-analysis with economic evaluation. Pharmacoeconomics. 2001;195:565-575

Drummond MF, O’Brien B, Stoddart GL and Torrance GW. 1997 (2nd Ed) Methods for the Economic Evaluation of Health Care Programs (2nd Ed). Oxford Medical Publications, Oxford. Pg 170

Furlong W, Feeney D, Torrance GW, Barr R, and Horsman J. (1990). Guide to the design and development of health-state utility instrumentation. McMaster University: CHEPA Working Paper $90-9.

Hawthorne G, Richardson J, Day N. A comparison of the Assessment of Quality of Life (AQoL) with four other generic utility instruments. Annals of Medicine 2001,33;5: 358-370

Salkeld G. Cameron ID, Cumming RG, Easter S, Seymour J, Kurrle SE, Quine S. Fear of falling and hip fracture related quality of life - measuring the preferences of older women: a time trade-off study. BMJ 2000;320:341-346.

Willis, Odegaard K, Persson U, Hedbrnat J, Mellstorm D, Hammar A. A cost-effectiveness model of tibolone as treatment for the prevention of osteoporotic fractures in postmenopausal women in Sweden. Clinicial drug Investigation. 2001;21,2:115-127.