ABSTRACT: Adherence and persistence with osteoporosis medications are poor. We conducted a systematic literature review of interventions to improve adherence and persistence with osteoporosis medications. Seven studies met eligibility requirements and were included in the review. Few interventions were efficacious, and no clear trends regarding successful intervention techniques were identified. However, periodic follow-up interaction between patients and health professionals appeared to be beneficial.
Adherence and persistence with pharmacologic therapy for osteoporosis are suboptimal. Our goal was to examine the design and efficacy of published interventions to improve adherence and persistence.
We searched medical literature databases for English-language papers published between January 1990 and July 2008. We selected papers that described interventions and provided results for control and intervention subjects. We assessed the design and methods of each study, including randomization, blinding, and reporting of drop-outs. We summarized the results and calculated effect sizes for each trial.
Seven studies met eligibility requirements and were included in the review. Five of the seven studies provided adherence data. Of those five studies, three showed a statistically significant (p < or = 0.05) improvement in adherence by the intervention group, with effect sizes from 0.17 to 0.58. Five of the seven studies provided persistence data. Of those five, one reported statistically significant improvement in persistence by the intervention group, with an effect size of 0.36.
Few interventions were efficacious, and no clear trends regarding successful intervention techniques were identified in this small sample of studies. However, periodic follow-up interaction between patients and health professionals appeared to be beneficial.
Osteoporosis International 06/2009; 20(12):2127-34. · 4.58 Impact Factor
ABSTRACT: We have designed an innovative randomized controlled trial for improving adherence with osteoporosis medications. Recruitment and randomization have been successful. Also, the counseling intervention has been well accepted by subjects randomized to this treatment arm.
While many effective treatments exist for osteoporosis, most people do not adhere to such treatments long term. No proven interventions exist to improve osteoporosis medication adherence. We report here on the design and initial enrollment in an innovative randomized controlled trial aimed at improving adherence to osteoporosis treatments.
The trial represents a collaboration between academic researchers and a state-run pharmacy benefits program for low-income older adults. Beneficiaries beginning treatment with a medication for osteoporosis are targeted for recruitment. We randomize consenting individuals to receive 12 months of mailed education (control arm) or an intervention consisting of one-on-one telephone-based counseling and the mailed education. Motivational interviewing forms the basis for the counseling program which is delivered by seven trained and supervised health counselors over ten telephone calls. The counseling sessions include scripted dialog and open-ended questions about medication adherence and its barriers, as well as structured questions. The primary end point of the trial is medication adherence measured over the 12-month intervention period. Secondary end points include fractures, nursing home admissions, health care resource utilization, and mortality.
During the first 7 months of recruitment, we have screened 3,638 potentially eligible subjects. After an initial mailing, 1,115 (30.6%) opted out of telephone recruitment and 1,019 (28.0%) could not be successfully contacted. Of the remaining, 879 (24.2%) consented to participate and were randomized. Women comprise over 90% of all groups; mean ages range from 77 to 80 years old, and the majority in all groups was white. The distribution of osteoporosis medications was comparable across groups and the median number of different prescription drugs used in the prior year was eight to ten.
We have developed a novel intervention for improving osteoporosis medication adherence. The intervention is currently being tested in a large-scale randomized controlled trial. If successful, the intervention may represent a useful model for improving adherence to other chronic treatments.
Osteoporosis International 06/2009; 21(1):137-44. · 4.58 Impact Factor
ABSTRACT: Weekly bisphosphonates are the primary agents used to treat osteoporosis. Although these agents are generally well tolerated, serious gastrointestinal adverse events, including hospitalization for gastrointestinal bleed, may arise. We compared the gastrointestinal safety between weekly alendronate and weekly risedronate and found no important difference between new users of these agents.
Weekly bisphosphonates are the primary agents prescribed for osteoporosis. We examined the comparative gastrointestinal safety between weekly bisphosphonates.
We studied new users of weekly alendronate and weekly risedronate from June 2002 to August 2005 among enrollees in a state-wide pharmaceutical benefit program for seniors. Our primary outcome was hospitalization for upper gastrointestinal bleed. Secondary outcomes included outpatient diagnoses for upper gastrointestinal disease, symptoms, endoscopic procedures, use of gastroprotective agents, and switching between therapies. We used Cox proportional hazard models to compare outcomes between agents within 120 days of treatment initiation, adjusting for propensity score quintiles. We also examined composite safety outcomes and stratified results by age and prior gastrointestinal history.
A total of 10,420 new users were studied, mean age = 79 years (SD, 6.9), and 95% women. We observed 31 hospitalizations for upper gastrointestinal bleed (0.91 per 100 person-years) within 120 days of treatment initiation. Adjusting for covariates, there was no difference in hospitalization for upper gastrointestinal bleed among those treated with risedronate compared with alendronate (HR, 1.12; 95%CI, 0.55 to 2.28). Risedronate switching rates were lower; otherwise, no differences were observed for secondary or composite outcomes.
We found no important difference in gastrointestinal safety between weekly oral bisphosphonates.
Osteoporosis International 04/2009; 20(10):1735-47. · 4.58 Impact Factor
ABSTRACT: While nitrogen-containing bisphosphonates have been shown to reduce fracture risk in postmenopausal women and men, their safety in the period after a fracture is unclear. In fully adjusted multivariable regression models, bisphosphonate use in the post-fracture period was associated with an increased probability of non-union [odds ratio (OR) 2.37, 95% confidence interval (CI) 1.13-4.96]. Clinicians might consider waiting for several months before introduction of a bisphosphonate after a fracture.
While nitrogen-containing bisphosphonates have been shown to reduce fracture risk in postmenopausal women and men, their safety in the period after a fracture is unclear. We examined the risk of non-union associated with post-fracture bisphosphonate use among a group of older adults who had experienced a humerus fracture.
We conducted a nested case-control study among subjects who had experienced a humerus fracture. From this cohort, cases of non-union were defined as those with an orthopedic procedure related to non-union 91-365 days after the initial humerus fracture. Bisphosphonate exposure was assessed during the 365 days prior to the non-union among cases or the matched date for controls. Multivariable logistic regression models were examined to calculate the OR and 95% CI for the association of post-fracture bisphosphonate use with non-union.
From the cohort of 19,731 patients with humerus fractures, 81 (0.4%) experienced a non-union. Among the 81 cases, 13 (16.0%) were exposed to bisphosphonates post-fracture, while 69 of the 810 controls (8.5%) were exposed in the post-fracture interval. In fully adjusted multivariable regression models, bisphosphonate use in the post-fracture period was associated with an increased odds of non-union (OR 2.37, 95% CI 1.13-4.96). Albeit limited by small sample sizes, the increased risk associated with bisphosphonate use persisted in the subgroup of patients without a history of osteoporosis or prior fractures (OR 1.91, 95% CI 0.75-4.83).
In this study of older adults, non-union after a humerus fracture was rare. Bisphosphonate use after the fracture was associated with an approximate doubling of the risk of non-union.
Osteoporosis International 11/2008; 20(6):895-901. · 4.58 Impact Factor