Orthopaedic Management Improves the Rate of Early Osteoporosis Treatment After Hip Fracture: A Randomized Clinical Trial

Miki, Roberto A. MD; Oetgen, Matthew E. MD; Kirk, Jessica MD; Insogna, Karl L. MD; Lindskog, Dieter M. MD

Journal of Bone & Joint Surgery - American Volume:
doi: 10.2106/JBJS.G.01246
Scientific Articles
Abstract

Background: Although osteoporosis is strongly associated with hip fractures, the initiation of osteoporosis treatment following hip fractures occurs at surprisingly low rates of between 5% and 30%. Currently, most patients receiving treatment have been referred back to their primary care physician for osteoporosis management. The purpose of this study was to compare the effect of osteoporosis management initiated by the orthopaedic team and osteoporosis management initiated by the primary care physician on the rates of treatment at six months.

Methods: A prospective randomized trial was conducted to assess the difference in the rate of osteoporosis treatment when an in-house assessment of osteoporosis was initiated by the orthopaedic surgeon and follow-up was conducted in a specialized orthopaedic osteoporosis clinic compared with osteoporosis education and “usual” care.

Results: Sixty-two patients were enrolled in the study. Thirty-one patients each were in the control and intervention groups. The percentage of patients who were on pharmacologic treatment for osteoporosis at six months after the fracture was significantly greater when the evaluation was initiated by the orthopaedic surgeon and was managed in a specialized orthopaedic osteoporosis clinic (58%) than when treatment was managed by a primary care physician (29%) (p = 0.04).

Conclusions: An active role by orthopaedic surgeons in the management of osteoporosis improves the rate of treatment at six months following a hip fracture.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

Author Information

1Department of Orthopaedics, Miller School of Medicine, University of Miami, 900 N.W. 17th Street, Miami, FL 33136. E-mail address: rmiki2@med.miami.edu

2Department of Orthopaedic Surgery, Yale University School of Medicine, 800 Howard Avenue, New Haven, CT 06510

3Department of Internal Medicine, Section of Endocrinology, Yale University School of Medicine, P.O. Box 208020, New Haven, CT 06520-8020

Article Outline

Hip fractures occur most often from falls on structurally compromised bone secondary to osteoporosis1. Hip, wrist, and vertebral fractures in the elderly from low-energy mechanisms are often termed fragility fractures. The initiation of antiresorptive pharmacologic therapy for osteoporosis after a fragility fracture has been shown to significantly (p < 0.05) decrease the risk of subsequent fractures2-4. In one recent study, mortality after a hip fracture was decreased with the intravenous administration of a bisphosphonate4. Although the importance of the initiation of osteoporosis treatment following a fragility fracture is indisputable, a surprisingly low percentage of patients begin osteoporosis treatment following such a fracture5-8. Studies that investigated the treatment of osteoporosis following hip fractures found that osteoporosis treatment rates ranged from 5% to 30%8-17. These disappointing treatment rates have led researchers to attempt to identify possible barriers to osteoporosis treatment following hip fractures and to address them with use of letters, specialized clinics, liaisons, and consultations, which have had varied success8,10,18,19.

The purpose of the current study was to assess the efficacy of an inpatient osteoporosis evaluation initiated by orthopaedic surgeons combined with follow-up in a specialized orthopaedic osteoporosis clinic. We conducted a randomized controlled trial to investigate our hypothesis that the rate of treatment for osteoporosis would be higher among patients whose evaluation was initiated by the treating surgeon and whose treatment was managed by an orthopaedic osteoporosis clinic compared with those for whom the responsibility of their evaluation and treatment was placed solely on the primary care physician.

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Materials and Methods

This protocol was approved by the institutional review board for our institution.

Prior to the study, permission was obtained from orthopaedic surgeons in the New Haven, Connecticut, area to approach all of their hip fracture patients at Yale-New Haven Hospital about enrollment in the study. All English-speaking patients admitted with a low-energy hip fracture, including intertrochanteric, subtrochanteric, and femoral neck fractures, were identified for possible enrollment by means of the daily census of admitted patients to the orthopaedic service. Patients who were currently taking a prescription medication for osteoporosis other than calcium and vitamin D (e.g., bisphosphonate, estrogen treatment specifically for osteoporosis, calcitonin, teriparatide, or selective estrogen receptor modulators) were excluded from the study. Patients with a high-energy fracture mechanism or pathologic fracture were also excluded. In most cases, eligible patients were approached prior to surgery, and informed consent was obtained from the patient, next of kin, or an individual with power of attorney (see Figure 1 for a diagram of the protocol algorithm). Following consent, a detailed questionnaire was completed by the patient or family with the help of one of the investigators. Prior to randomization, all patients and families received fifteen minutes of education on hip fractures, fracture prevention, and osteoporosis from one of the investigators.

The patients were randomly assigned to either the intervention group or the control group. The patients assigned to the intervention group received an osteoporosis evaluation in the hospital. The workup entailed assessment of bone density of the lumbar spine and unaffected hip by a dual x-ray absorptiometry scan and evaluation of serum measures of parathyroid hormone, 25-hydroxyvitamin D, white blood-cell count, hemoglobin, hematocrit, platelet count, sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine, calcium, magnesium, and phosphate. Luteinizing hormone levels were also screened in male subjects. The dual x-ray absorptiometry scan and blood studies were typically obtained on the first or second postoperative day. Prior to discharge, patients in the intervention group began taking 1500 mg of calcium and 800 IU of vitamin D3 daily and were given a follow-up appointment between two weeks and one month postoperatively in a specialized orthopaedic osteoporosis clinic. The clinic was run by the senior author (D.M.L.), a practicing orthopaedic surgeon. At the follow-up appointment, the investigative team reviewed the results of the laboratory studies and dual x-ray absorptiometry, reinforced education, and started treatment with 35 mg of risedronate. The patients were followed at two months and six months postoperatively with clinic visits or telephone calls to determine adherence with the medication and to monitor for complications. The responsibility for medication adherence and management of the patient after six months was transferred to the primary care physician.

The patients assigned to the control group also began taking 1500 mg of calcium and 800 IU of vitamin D3 daily. Prior to discharge, the control patients and their families were instructed to approach their primary care physicians for an osteoporosis evaluation. A nonblinded follow-up telephone call was made at six months to assess the workup and treatment of osteoporosis for each control patient. If a workup or therapy had not been initiated, patients were once again advised to seek care from their primary care physician and were also invited to visit the orthopaedic osteoporosis clinic.

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Statistics and Power Analysis

The Fisher exact test and the Student t test were used to assess the significance of the differences between the two groups. A p value of <0.05 was selected as significant. Prior to the study, a power analysis was performed to calculate the number of patients required. The treatment rate at six months was selected as the primary outcome measure. A sample size of 120 patients was calculated on the basis of an alpha of 0.05 and a beta of 0.8 in order to detect a predicted difference of 25% for the primary outcome, which was based on previous studies.

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Results

Enrollment in the study was conducted from May 2005 to September 2006. During this period, 238 patients sustained a hip fracture and were identified as possible candidates for the study. Seventy-four patients were excluded for the following reasons: twenty-three had a high-energy mechanism of injury, five were non-English speakers, six had a pathologic fracture, and forty patients were currently on treatment. Sixty patients were not approached during their hospital stay and thus were unable to enroll in the study. Forty-two patients declined to participate in the study despite meeting all inclusion criteria. Of those who did not participate, twenty-three patients refused because of transportation and time concerns. In the end, sixty-two patients enrolled in the study and were randomized via sealed envelope to either the intervention group or the control group (Fig. 1). Thirty-one individuals were randomized to each group. The average age of the combined group was 79.2 years. Seventy-one percent of the individuals were female. All but three patients were white. Baseline data were collected by means of a detailed questionnaire (see Appendix).

Thirty-one patients were randomized to the control group (Fig. 1). Five patients died in the control group prior to the six-month follow-up and were excluded from the analysis. Two patients were lost to follow-up and were also excluded from the analysis. Twenty-four patients in the control group completed the study. All patients had a visit with their primary care physician in the six months following the fracture. Thirty-nine percent of these patients recalled a conversation with their primary care physician about osteoporosis. Ninety-five percent of the patients saw their orthopaedic surgeon in the six months following their fracture. None of the patients in the control group recalled having conversation with their orthopaedic surgeon about osteoporosis. One patient sustained a fragility fracture in the six months following the hip fracture but was not begun on treatment before or after the second fracture. Seven control patients (29%) had a dual x-ray absorptiometry scan. Eight patients (33%) were started on antiresorptive treatment (bisphosphonate) during the six-month interval after the hip fracture. One of these patients stopped bisphosphonate treatment because of intolerance to the medication and was not started on another medication. At the six-month time point after the hip fracture, seven control patients (29%) were taking a bisphosphonate.

Thirty-one patients were randomized to the intervention group (Fig. 1). Two patients died prior to the six-month follow-up examination and were excluded from the analysis. Three patients were lost to follow-up and were also excluded from the analysis. The remaining twenty-six patients completed the study. No patient sustained a fragility fracture in the subsequent six months. Twenty-six patients obtained a dual x-ray absorptiometry scan while in the hospital. Of those who completed the study, twenty patients were started on risedronate during the six months following the fracture. Six patients were never started on medication. All patients who did not begin taking risedronate did not do so because of an inability to obtain transportation to the follow-up appointments in the osteoporosis clinic. Of the twenty who started medication, five patients stopped pharmacologic treatment before their six-month follow-up examination. Of those who discontinued treatment, two patients stopped treatment because of a hospitalization; one stopped medication to simplify his medication regimen; and two patients stopped bisphosphonate treatment because of gastrointestinal side effects. Fifteen patients (58%) were still taking medication at six months. Thirteen were taking risedronate, one was taking alendronate, and one was taking calcitonin nasal spray.

With regard to the primary outcome of the study, i.e., the number of patients on osteoporosis treatment at six months after fracture, the intervention group had significantly higher numbers of patients on treatment than did the control group (fifteen compared with seven; p = 0.04) (Table I). As to be expected, the number of patients started on treatment and the number obtaining a dual x-ray absorptiometry scan within six months of the hip fracture were substantially higher in the intervention group. Twenty patients in the intervention group were started on osteoporosis medication as opposed to eight patients in the control group. Twenty-six patients in the intervention group had a dual x-ray absorptiometry scan compared with seven patients in the control group (Table I).

The metabolic screen revealed a high proportion of abnormalities within the intervention group. Serum levels of 25-hydroxyvitamin D were <32 ng/mL in 97% of the patients in the intervention group, indicating widespread vitamin-D insufficiency. For 52% of the patients in the intervention group, the level was <20 ng/mL. Parathyroid hormone levels were >25 nLeq/mL in 77% of the patients. The mean bone mineral density T-scores (and standard deviation) in the intervention group were −2.3 ± 1 for the femoral neck, −1.7 ± 1.2 for the total hip, and −1.2 ± 1.6 for the spine (Table II). Of the treatment patients, 38% had at least one T score of less than −2.5.

Our trial was stopped prior to reaching our pretrial estimate of 120 patients because an interim analysis demonstrated a significant difference in the rate of treatment between the groups (p = 0.04). Continuation of the study was, therefore, deemed unethical.

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Discussion

The results of this study indicate an improved rate of evaluation and treatment of osteoporosis in hip fracture patients when osteoporosis management is initiated in the hospital by the orthopaedic surgeon and follow-up is completed in a specialized orthopaedic osteoporosis clinic compared with when the responsibility for evaluation and treatment is transferred right away to the primary care physician. An in-house evaluation for osteoporosis by the orthopaedic surgeon coupled with the initiation of treatment in an osteoporosis clinic two weeks to one month following hip surgery resulted in a 58% rate of treatment at six months. In comparison, only 29% of the patients in the control group were receiving treatment at six months postoperatively. The rate of treatment in our control group is consistent with previously reported results8,10-15. The difference in the rate of treatment between our study groups was significant (p = 0.04), but we were unable, because of the small number of patients, to demonstrate a difference in the rate of new fractures.

Although osteoporosis is strongly associated with hip fractures20, studies examining osteoporosis treatment following a hip fracture have found rates of between 5% and 30%8-17. This low treatment rate is reflected in our control group. Despite the fact that 100% of our control patients saw their primary care physician, only 39% recalled having a discussion about osteoporosis with their primary care physician. This low percentage may reflect either an actual failure of dialogue or a patient recall issue. Nevertheless, only 31% of the control patients had a dual x-ray absorptiometry scan, only 33% of control patients were started on medication, and only 29% of control patients were on treatment at six months. Historically, orthopaedic surgeons have relied on primary care physicians to take responsibility for the management of osteoporosis. The care provided to our control group reflected such attitudes, as no patient in the control group recalled the orthopaedic surgeon discussing osteoporosis during the follow-up office visits. Two factors again may contribute to this low level of recall of an osteoporosis discussion: an actual low level of surgeon discussion and/or patient recall. In this study, orthopaedic surgeons were not given instructions on how to conduct their follow-up visits. Therefore, the level of discussion engaged in likely represents the level of typical care in our area. Patient recall, especially in this elderly group, may also underrepresent the true frequency of osteoporosis discussion. Nevertheless, the low rate of osteoporosis treatment seen in our control group represents a failure to address osteoporosis at our institution.

Interventions to increase treatment rates have been studied previously. Gardner et al.11 reported the results of a simple intervention in a randomized controlled trial. The intervention group received a pamphlet with a series of questions directed to the primary care physician. The intervention improved evaluation rates of osteoporosis to 48%. However, when the number of subjects actually on treatment was considered, the “success” rate was 27%, which is comparable with our control group. Hawker et al.18 also found that a letter had a limited effect on the final osteoporosis treatment rate; however, consistent with the study by Gardner et al., a letter did improve the workup and diagnosis rate.

In a step further than the above studies, Kaufman et al. described two protocols that increased inpatient osteoporosis evaluation and increased osteoporosis treatment at discharge to 63% at Northwestern University21. Similarly, a study by Streeten et al. found that an inpatient metabolic evaluation and endocrinology consultation increased the rate of osteoporosis treatment to 65% in the patients who received the intervention10. However, orthopaedic surgeons failed to consult the endocrinology service for 63% of the potentially eligible subjects. The 58% rate of treatment in our study was comparable with the results obtained by both of these studies. Each study demonstrated the benefit of an in-house evaluation over an outpatient evaluation.

The role of osteoporosis program coordinators has also been studied. In Toronto, the use of a program led to “appropriate” osteoporosis care for 94.5% of 128 inpatients22. Similarly, McLellan et al., in a study in Glasgow, demonstrated that a liaison service improved the treatment of osteoporosis after a fragility fracture19. Fifty-six percent of the patients received treatment. Neither study noted rates of bisphosphonate use or rates of fracture. Although the principles of each study are likely universally effective, the programs may not be effective in all medical systems. As in our investigation, however, both of these studies demonstrated the need for a strong and active participation by orthopaedic surgeons.

Our study also found a high proportion of patients with vitamin-D deficiency and a substantial proportion with elevated parathyroid hormone levels (Table II). We believe that these laboratory screening tests for secondary causes of osteoporosis should be strongly encouraged, and vitamin-D supplementation should be routine for all patients because of the high prevalence of deficiency in this population.

One of the primary reasons for the low treatment rate of osteoporosis following a hip fracture is the lack of consensus as to who is responsible for initiating treatment1,21. Many surgeons consider this responsibility to lie with the patient's primary care physician. One study by Simonelli et al.23, surveying both primary care physicians and orthopaedic surgeons about the responsibility for treating osteoporosis, revealed that both groups agreed that treatment for this condition fell under the domain of primary care physicians. Another study by Skedros et al.24, however, revealed that even when orthopaedic surgeons did acknowledge the appropriateness of assuming responsibility for initiating treatment of osteoporosis, they were hesitant to do so because of concerns over drug side effects and a reluctance to assume the responsibility of long-term management. Although, in the past, the onus of treatment of osteoporosis has been placed on primary care physicians, studies have indicated that a large number of primary care physicians do not feel adequately informed about the treatment of osteoporosis23,25,26. The present study attempted to address the physician assumption-of-responsibility barrier. Although our results suggest a significant improvement in osteoporosis treatment when orthopaedic surgeons take a more active role, our treatment rate was less than we had hoped. Similar to other investigations on the rates of osteoporosis treatment following fractures, a number of barriers to treatment account for the less than perfect treatment rate in our study. Barriers to treatment that have been proposed in the literature are a lack of patient and physician education, transportation concerns, the addition of a “new” physician to the patient's treatment team, a lack of financial incentives, and the cost of treatment21,23,27,28.

Transportation remains a major barrier to medical care access. The 38% rate of refusal to consent by eligible patients in this study reflects this problem because the most common reason for refusal to enroll was transportation. In addition, we had six patients in our intervention group who failed to return for follow-up in the clinic secondary to transportation issues. Currently, in the United States, Medicare does not cover the cost of transportation for routine medical care nor does it cover the cost of an ambulance to a physician's office29.

Another barrier to treatment appears to be patient nonacceptance of a “new” physician on their medical team. Previous studies that have looked at the effect of a separate osteoporosis clinic have had limited success. Kaiser Permanente in California attempted to establish a program for osteoporosis care after fractures27. Their program, although successful at improving treatment rates for the patients who enrolled, was limited because of poor patient acceptance of the program. Only 23% of the eligible patients completed their program. For those who had indications for treatment, 65% of the patients accepted pharmacologic treatment. The authors theorized that patients were reluctant to add a “new” physician to their care team.

Clinical follow-up in our intervention group was not perfect; only 77% (twenty) of the twenty-six patients in the intervention group actually returned for a follow-up visit. Conceivably, this may be the result of a “new” physician or a transportation barrier. All of those who attended the follow-up appointment were started on treatment. Nevertheless, 95% of the patients in both the intervention and control groups visited both their orthopaedic surgeon and their primary care physician in the first six months after the fracture. This is consistent with a previous study that demonstrated that patients see their primary care physician an average of three times within one year of a hip fracture14. In addition, there was a trend toward increased treatment with increased visits. As highlighted above, the downsides to a separate clinic are an additional strain on the limited transportation resources and the addition of a “new” physician. The optimal solution with the least strain on patients and the health-care system would be for the surgeon to initiate the evaluation in the hospital and to provide the treatment during the subsequent postoperative follow-up visits.

A number of future directions for research into the improvement of osteoporosis treatment following hip fractures are suggested by the present study. One is the assessment of the impact of initiating osteoporosis treatment during the hospitalization of a patient rather than relying on a follow-up appointment at a clinic. While there can be problems with starting medication in the hospital because of the need for the patient to stay upright for thirty minutes after the intake of an oral bisphosphonate, intravenous bisphosphonates can be utilized30. In a recent prospective, double-blind, placebo-controlled, randomized trial of zoledronic acid in the treatment of hip fracture patients, the results at a median follow-up of 1.9 years showed that an annual infusion of zoledronic acid reduced fracture rates and mortality compared with a placebo4. This approach would likely have improved our treatment rate substantially as six of our intervention patients failed to start bisphosphonate treatment solely because of follow-up transportation issues. Support for an inpatient strategy comes from other studies demonstrating improvements in compliance and treatment rates in other disease processes, such as myocardial infarction, when medications were started in the hospital31,32.

The importance of treatment is further supported by evidence of the increased risk of another hip fracture in these patients. Rates of another hip fracture have been reported to range from 5% in the first year to 29% over twenty years33-36. In addition, there is evidence of loss of bone mineral density in the contralateral hip during recovery from the first hip fracture, likely because of a decrease in activity levels37,38. Some might argue that the opportunity to intervene had passed for these patients, but this argument is flawed in that this group is at an extremely high risk for fracture and subsequently will benefit the most from treatment. Treatment has been shown to decrease the risk of future fracture by 50% by the first year for alendronate2 and possibly by six months for risedronate39. The decreased fracture risk appears to be attributable to factors independent of gains in bone mineral density39,40. Thus, the importance of osteoporosis treatment cannot be understated.

A possible concern, however, if bisphosphonate treatment is initiated while the patient is hospitalized is the assumption of responsibility for the management of this medication once the patient has been discharged. Issues of responsibility and the transferring of medical management to the primary care physician continue to arise even if treatment is initiated at the hospital. The communication of the need for the primary care physician to then assume responsibility poses an area of possible confusion and miscommunication—thus, a potential barrier to treatment—and may raise liability issues. This is reflected in the concerns expressed by orthopaedic surgeons regarding the long-term management of osteoporosis medications and was a reason why many were reluctant to initiate treatment themselves24. We addressed this concern at the end of our study through a letter to the primary care physician detailing our treatment and requesting transfer of responsibility of care. There were no issues with the transfer of responsibility.

Several shortcomings of our study are evident. One limitation is that we relied on self-reporting by our patients with regard to their outcomes and medications. No independent confirmation of their self-reported data was performed. This potential source of error may have been avoided with additional confirmatory telephone calls to pharmacies or primary care physicians. This reliance on self-reporting is a bias in our study because patient recall can be unreliable, especially in elderly individuals. In an attempt to limit this bias, we conducted interviews with family members or caretakers for patients who were demented or unable to communicate. Nevertheless, this form of reporting may have underestimated the overall rate of osteoporosis discussion and the rate of treatment. We also had a small number of patients at a single tertiary-care center that may not be representative of the larger group of hip fracture patients across the country and this may limit the applicability of this protocol to other centers. An additional concern is the design of our control group. The control group represented only a slight improvement over the level of care at our institution at the time of the design of the study, and previous studies have demonstrated the poor outcomes from education alone. This weak control group may have biased our study toward success and does not allow comparison with other interventions. Lastly, sixty patients were never approached to enroll in the study. This represents 29% of the potential candidates for the study. We did not collect information on this group, and we are unable to comment on how this group might have biased our results except that this may demonstrate an impracticality of implementing this study in the real world as it can be a labor-intensive process. The failure to enroll these patients was due to limitations in the availability of study personnel as we had no funding for our study and relied on the volunteer time of our personnel.

This study clearly demonstrates improved rates of early osteoporosis treatment when the osteoporosis evaluation is initiated by the treating orthopaedic surgeon while the patient is in the hospital and treatment is initiated by an orthopaedic osteoporosis clinic. Although the rate of treatment in the intervention group at six months was significantly improved over that in the control group, this improvement was substantially lower than we had hoped. Despite the many barriers to treatment that were encountered, the present study demonstrated improved rates of treatment by addressing a major barrier: the confusion over who is responsible for osteoporosis care after a fragility fracture. Future studies should build on our finding that there is a need for orthopaedic surgeons to assume a more active role in the treatment of osteoporosis and should begin to investigate and to establish a protocol for the optimization of the treatment of osteoporosis after a hip fracture.

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Appendix Cited Here...

A table showing detailed baseline characteristics on all sixty-two study patients is available with the electronic versions of this article, on our web site at jbjs.org (go to the article citation and click on “Supplementary Material”) and on our quarterly CD/DVD (call our subscription department, at 781-449-9780, to order the CD or DVD).

NOTE: The authors thank the 7-7 staff for their patient care and support of the study, the current and former Yale orthopaedic residents who helped to identify potential candidates for the study, and Christine Simpson, Gina Bejnerowicz, and Joanne Petrosino who performed the metabolic evaluations and dual x-ray absorptiometry scans.

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Investigation performed at the Department of Orthopaedic Surgery, Yale University School of Medicine, New Haven, Connecticut

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