Effectiveness of bisphosphonate therapy in a community setting

Adrianne C. Feldstein, Derek Weycker, Gregory A. Nichols, Gerry Oster, Gabriela Rosales, David L. Boardman, Nancy A Perrin

Research output: Contribution to journalArticle

Abstract

Background: Osteoporosis is a major cause of morbidity and mortality. Clinical trials have shown the effectiveness of bisphosphonates, the most commonly prescribed treatments, in reducing fracture risk. The population-based effectiveness of bisphosphonates in clinical practice is uncertain. Methods: This retrospective cohort study used a matched design that compared time to clinical fracture in at-risk community women who initiated a bisphosphonate medication between 7/1/1996 and 6/30/2006 to those who did not. The study was conducted in an HMO in Oregon and Washington. Clinical electronic databases provided data. Eligible members were newly treated women aged ≥ 55 years with either a BMD T-score of ≤ - 2.0 or a prior qualifying clinical fracture. They did not have contraindications for bisphosphonate therapy or a diagnosis associated with secondary osteoporosis (n = 1829). They were matched to a similar comparison group (n = 1829; total N = 3658). The primary outcome was the first new incident fracture validated through chart review (closed clinical fracture of any bone except face, skull, finger, or toe or pathological fracture secondary to malignancy) during follow-up. An intention-to-treat analysis used Cox proportional hazards models to estimate the hazard ratio of fracture for treated relative to comparison patients, adjusting for differences in potential confounders. Results: Treated and comparison patients were similar in mean age (72.0 years) and history of fracture (about 45%). The treated group had more women with T-scores of ≤ - 2.5 (67.3% vs. 54.7%) and a lower mean weight (146.6 lb vs. 151.8 lb). Only about 45% of treated patients had a bisphosphonate medication possession ratio (MPR) of ≥ 0.80. During follow-up, 198 (10.8%) of patients in the treated group had incident fractures, vs. 179 (9.8%) of patients in the comparison group. After adjustments, patients in the treated group were 0.91 (95% CI 0.74-1.13) as likely to have an incident fracture as the comparison patients (p = 0.388). The treatment effect remained non-significant after accounting for MPR. Conclusions: In this analysis of a community cohort of post-menopausal women at risk, the fracture risk of patients who received bisphosphonates did not differ significantly from those who did not. An enhanced understanding of this lack of treatment effect is urgently needed.

Original languageEnglish (US)
Pages (from-to)153-159
Number of pages7
JournalBone
Volume44
Issue number1
DOIs
StatePublished - Jan 2009
Externally publishedYes

Fingerprint

Diphosphonates
Therapeutics
Osteoporosis
Closed Fractures
Spontaneous Fractures
Intention to Treat Analysis
Health Maintenance Organizations
Toes
Proportional Hazards Models
Skull
Fingers
Cohort Studies
Retrospective Studies
Clinical Trials
Databases
Morbidity
Weights and Measures
Bone and Bones
Mortality
Population

Keywords

  • Bisphosphonate
  • Fracture risk
  • Post-menopausal osteoporosis

ASJC Scopus subject areas

  • Physiology
  • Endocrinology, Diabetes and Metabolism
  • Histology

Cite this

Feldstein, A. C., Weycker, D., Nichols, G. A., Oster, G., Rosales, G., Boardman, D. L., & Perrin, N. A. (2009). Effectiveness of bisphosphonate therapy in a community setting. Bone, 44(1), 153-159. https://doi.org/10.1016/j.bone.2008.09.006

Effectiveness of bisphosphonate therapy in a community setting. / Feldstein, Adrianne C.; Weycker, Derek; Nichols, Gregory A.; Oster, Gerry; Rosales, Gabriela; Boardman, David L.; Perrin, Nancy A.

In: Bone, Vol. 44, No. 1, 01.2009, p. 153-159.

Research output: Contribution to journalArticle

Feldstein, AC, Weycker, D, Nichols, GA, Oster, G, Rosales, G, Boardman, DL & Perrin, NA 2009, 'Effectiveness of bisphosphonate therapy in a community setting', Bone, vol. 44, no. 1, pp. 153-159. https://doi.org/10.1016/j.bone.2008.09.006
Feldstein AC, Weycker D, Nichols GA, Oster G, Rosales G, Boardman DL et al. Effectiveness of bisphosphonate therapy in a community setting. Bone. 2009 Jan;44(1):153-159. https://doi.org/10.1016/j.bone.2008.09.006
Feldstein, Adrianne C. ; Weycker, Derek ; Nichols, Gregory A. ; Oster, Gerry ; Rosales, Gabriela ; Boardman, David L. ; Perrin, Nancy A. / Effectiveness of bisphosphonate therapy in a community setting. In: Bone. 2009 ; Vol. 44, No. 1. pp. 153-159.
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abstract = "Background: Osteoporosis is a major cause of morbidity and mortality. Clinical trials have shown the effectiveness of bisphosphonates, the most commonly prescribed treatments, in reducing fracture risk. The population-based effectiveness of bisphosphonates in clinical practice is uncertain. Methods: This retrospective cohort study used a matched design that compared time to clinical fracture in at-risk community women who initiated a bisphosphonate medication between 7/1/1996 and 6/30/2006 to those who did not. The study was conducted in an HMO in Oregon and Washington. Clinical electronic databases provided data. Eligible members were newly treated women aged ≥ 55 years with either a BMD T-score of ≤ - 2.0 or a prior qualifying clinical fracture. They did not have contraindications for bisphosphonate therapy or a diagnosis associated with secondary osteoporosis (n = 1829). They were matched to a similar comparison group (n = 1829; total N = 3658). The primary outcome was the first new incident fracture validated through chart review (closed clinical fracture of any bone except face, skull, finger, or toe or pathological fracture secondary to malignancy) during follow-up. An intention-to-treat analysis used Cox proportional hazards models to estimate the hazard ratio of fracture for treated relative to comparison patients, adjusting for differences in potential confounders. Results: Treated and comparison patients were similar in mean age (72.0 years) and history of fracture (about 45{\%}). The treated group had more women with T-scores of ≤ - 2.5 (67.3{\%} vs. 54.7{\%}) and a lower mean weight (146.6 lb vs. 151.8 lb). Only about 45{\%} of treated patients had a bisphosphonate medication possession ratio (MPR) of ≥ 0.80. During follow-up, 198 (10.8{\%}) of patients in the treated group had incident fractures, vs. 179 (9.8{\%}) of patients in the comparison group. After adjustments, patients in the treated group were 0.91 (95{\%} CI 0.74-1.13) as likely to have an incident fracture as the comparison patients (p = 0.388). The treatment effect remained non-significant after accounting for MPR. Conclusions: In this analysis of a community cohort of post-menopausal women at risk, the fracture risk of patients who received bisphosphonates did not differ significantly from those who did not. An enhanced understanding of this lack of treatment effect is urgently needed.",
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AU - Perrin, Nancy A

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N2 - Background: Osteoporosis is a major cause of morbidity and mortality. Clinical trials have shown the effectiveness of bisphosphonates, the most commonly prescribed treatments, in reducing fracture risk. The population-based effectiveness of bisphosphonates in clinical practice is uncertain. Methods: This retrospective cohort study used a matched design that compared time to clinical fracture in at-risk community women who initiated a bisphosphonate medication between 7/1/1996 and 6/30/2006 to those who did not. The study was conducted in an HMO in Oregon and Washington. Clinical electronic databases provided data. Eligible members were newly treated women aged ≥ 55 years with either a BMD T-score of ≤ - 2.0 or a prior qualifying clinical fracture. They did not have contraindications for bisphosphonate therapy or a diagnosis associated with secondary osteoporosis (n = 1829). They were matched to a similar comparison group (n = 1829; total N = 3658). The primary outcome was the first new incident fracture validated through chart review (closed clinical fracture of any bone except face, skull, finger, or toe or pathological fracture secondary to malignancy) during follow-up. An intention-to-treat analysis used Cox proportional hazards models to estimate the hazard ratio of fracture for treated relative to comparison patients, adjusting for differences in potential confounders. Results: Treated and comparison patients were similar in mean age (72.0 years) and history of fracture (about 45%). The treated group had more women with T-scores of ≤ - 2.5 (67.3% vs. 54.7%) and a lower mean weight (146.6 lb vs. 151.8 lb). Only about 45% of treated patients had a bisphosphonate medication possession ratio (MPR) of ≥ 0.80. During follow-up, 198 (10.8%) of patients in the treated group had incident fractures, vs. 179 (9.8%) of patients in the comparison group. After adjustments, patients in the treated group were 0.91 (95% CI 0.74-1.13) as likely to have an incident fracture as the comparison patients (p = 0.388). The treatment effect remained non-significant after accounting for MPR. Conclusions: In this analysis of a community cohort of post-menopausal women at risk, the fracture risk of patients who received bisphosphonates did not differ significantly from those who did not. An enhanced understanding of this lack of treatment effect is urgently needed.

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