Assessing adherence to teriparatide therapy,causes of nonadherence and effect of adherence on bone mineral density measurements in osteoporotic patients at high risk for fracture

Abstract

Objectives: To determine (a) adherence rates at 6, 9 and 18 months amongst patients receiving teriparatide treatment for severe osteoporosis and (b) causes of therapy discontinuation and the effect of teriparatide on bone mineral density (BMD) in adherent and nonadherent patients at different time intervals.

Methods: A retrospective chart review of 111 patients receiving teriparatide from September 2004 to June 2007 was performed. Patients’ self-reports were used to record adherence and causes of nonadherence at 6, 9 and 18 months. BMDs for all patients were measured using the same DXA scanner at baseline and follow up.

Results: Of 111 participants, 17 were male (mean age 60 years) and 94 were female (mean age 69 years). Of these, 12 did not initiate therapy and 4 were lost to follow up. Reported adherence was 89.6% at 6 months, 87.6% at 9 months and 74.7% at 18 months. Causes of nonadherence included cost (n = 4), no benefit (n = 1) and adverse events (n = 8). Common adverse events were leg cramps (n = 9), headache (n = 5) and myalgia (n = 4). Mean spine and femur BMD changes were 3.30% and 0.67% at 4—9 months respectively, and 5.39% and 0.77% at 10—18 months respectively.

Conclusion: Adherence to teriparatide was almost 90% at 9 months and decreased to 75% at 18 months. Adverse events led to nonadherence in 20% of patients. Those who were nonadherent had lower baseline BMD values than those who were adherent. Changes in BMD at the lumbar spine were greater than changes observed at the femoral neck.

Keywords

teriparatide compliance adverse events osteoporosis adherence

References

Adachi, J.D. , Hanley, D.A. , Lorraine, J.K. and Yu, M. ( 2007) Assessing compliance, acceptance, and tolerability of teriparatide in patients with osteoporosis who fractured while on antiresorptive treatment or were intolerant to previous antiresorptive treatment: an 18-month, multicenter, open-label, prospective study . Clin Ther 29: 2055-2067.

Body, J.J. ( 2002) Management of primary osteoporosis . Acta Clin Belg 57: 277-283.

Caro, J.J. , Ishak, K.J. , Huybrechts, K.F. , Raggio, G. and Naujoks, C. ( 2004) The impact of compliance with osteoporosis therapy on fracture rates in actual practice . Osteoporos Int 15: 1003-1008.

Cortet, B. and Benichou, O. ( 2006) Adherence, persistence, concordance: do we provide optimal management to our patients with osteoporosis? Joint Bone Spine 73: e1-e7.

Curtis, J.R. , Xi, J. , Westfall, A.O. , Cheng, H. , Lyles, K. , Saag, K.G. et al. (2009) Improving the prediction of medication compliance: the example of bisphosphonates for osteoporosis . Med Care 47: 334-341.

Dempster, D.W. , Cosman, F. , Kurland, E.S. , Zhou, H. , Nieves, J. , Woelfert, L. et al. (2001) Effects of daily treatment with parathyroid hormone on bone microarchitecture and turnover in patients with osteoporosis: a paired biopsy study . J Bone Miner Res 16: 1846-1853.

Dempster, D.W. , Cosman, F. , Parisien, M. , Shen, V. and Lindsay, R. ( 1993) Anabolic actions of parathyroid hormone on bone . Endocr Rev 14: 690-709.

Downey, T.W. , Foltz, S.H. , Boccuzzi, S.J. , Omar, M.A. and Kahler, K.H. ( 2006) Adherence and persistence associated with the pharmacologic treatment of osteoporosis in a managed care setting . South Med J 99: 570-575.

Gaudio, A. and Morabito, N. ( 2005) Pharmacological management of severe postmenopausal osteoporosis . Drugs Aging 22: 405-417.

10.

Gold, D.T. , Alexander, I.M. and Ettinger, M.P. ( 2006) How can osteoporosis patients benefit more from their therapy? Adherence issues with bisphosphonate therapy . Ann Pharmacother 40: 1143-1150.

11.

Harper, K.D. , Krege, J.H. , Marcus, R. and Mitlak, B.H. ( 2007) Osteosarcoma and teriparatide? J Bone Miner Res 22: 334 .

12.

Hodsman, A.B. , Bauer, D.C. , Dempster, D.W. , Dian, L. , Hanley, D.A. , Harris, S.T. et al. (2005) Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use . Endocr Rev 26: 688-703.

13.

Itkin, Z.S. , Hawkes, W. , Chandler, J. , Custis, B.V. , Hebel, J.R. , Sloanes., P.D. et al. (1999) Correlates of bone mineral density in nursing home residents . J Nutr Health Aging 3: 140-145.

14.

McClung, M.R. , San Martin, J. , Miller, P.D. , Civitelli, R. , Bandeira, F. , Omizo, M. et al. (2005) Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass . Arch Intern Med 165: 1762-1768.

15.

Miller, P.D. , Delmas, P.D. , Lindsay, R. , Watts, N.B. , Luckey, M. , Adachi, J. et al. (2008) Early responsiveness of women with osteoporosis to teriparatide after therapy with alendronate or risedronate . J Clin Endocrinol Metab 93: 3785-3793.

16.

Neer, R.M. , Arnaud, C.D. , Zanchetta, J.R. , Prince, R. , Gaich, G.A. , Reginster, J.Y. et al. (2001) Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis . N Engl J Med 344: 1434-1441.

17.

Reginster, J. , Minne, H.W. , Sorensen, O.H. , Hooper, M. , Roux, C. , Brandi, M.L. et al. (2000) Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group . Osteoporos Int 11: 83-91.

18.

Rosen, C.J. and Bilezikian, J.P. ( 2001) Clinical review 123: Anabolic therapy for osteoporosis . J Clin Endocrinol Metab 86: 957-964.

19.

Rossini, M. , Bianchi, G. , Di Munno, O. , Giannini, S. , Minisola, S. , Sinigaglia, L. et al. (2006) Determinants of adherence to osteoporosis treatment in clinical practice . Osteoporos Int 17: 914-921.

20.

Siris, E.S. , Harris, S.T. , Rosen, C.J. , Barr, C.E. , Arvesen, J.N. , Abbott, T.A. et al. (2006) Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases . Mayo Clin Proc 81: 1013-1022.

21.

Stroup, J. , Kane, M.P. and Abu-Baker, A.M. ( 2008) Teriparatide in the treatment of osteoporosis . Am J Health Syst Pharm 65: 532-539.

22.

Turbi, C. , Herrero-Beaumont, G. , Acebes, J.C. , Torrijos, A. , Grana, J. , Miguelez, R. et al. (2004) Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: An open-label, prospective, nonrandomized, observational study . Clin Ther 26: 245-256.

23.

Vahle, J.L. , Long, G.G. , Sandusky, G. , Westmore, M. , Ma, Y.L. and Sato, M. ( 2004) Bone neoplasms in F344 rats given teriparatide [rhPTH(1-34)] are dependent on duration of treatment and dose . Toxicol Pathol 32: 426-438.

24.

Weycker, D. , Macarios, D. , Edelsberg, J. and Oster, G. ( 2006) Compliance with drug therapy for postmenopausal osteoporosis . Osteoporos Int 17: 1645-1652.

25.

Yood, R.A. , Emani, S. , Reed, J.I. , Lewis, B.E. , Charpentier, M. and Lydick, E. ( 2003) Compliance with pharmacologic therapy for osteoporosis . Osteoporos Int 14: 965-968.