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The Effect of Alendronate on Bone Mineral Density in the Distal Part of the Femur and Proximal Part of the Tibia After Total Knee Arthroplasty
Ching-Jen Wang, MD1; Jun-Wen Wang, MD1; Lin-Hsiu Weng, MD1; Chia-Chen Hsu, MD1; Chung-Cheng Huang, MD1; Han-Shiang Chen, MD1
1 Department of Orthopedic Surgery (C.-J.W., J.-W.W., L.-H.W., C.-C. Hsu), Diagnostic Radiology (C.-C. Huang), and Surgery (H.-S.C.), Chang Gung Memorial Hospital, Kaohsiung Medical Center, 123 Ta-Pei Road, Niao-Sung Hsiang, Kaohsiung, Taiwan 833. E-mail address for C.-J. Wang: w281211@adm.cgmh.org.tw
View Disclosures and Other Information
In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from Chang Gung Research Fund (CMRP 1026). None of the authors 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, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated. The local pharmaceutical distributor supplied the alendronate to the patients in this study free of charge.
Investigation performed at the Departments of Orthopedic Surgery, Diagnostic Radiology, and Surgery, Chang Gung Memorial Hospital, Kaohsiung Medical Center, Kaohsiung, Taiwan

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2003 Nov 01;85(11):2121-2126
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Abstract

Background: Bone mineral density around the knee is related to the mechanical properties of bone. Alendronate has been shown to be effective for the treatment of osteoporosis and for reducing the rate of osteoporotic fractures. The purpose of the present study was to investigate the effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty in women.

Methods: Ninety-six women with an average age of seventy years who were undergoing total knee arthroplasty were randomly divided into two groups. Patients in the study group received oral alendronate at a dose of 10 mg/day for six months, whereas patients in the control group did not. The bone mineral density in the distal part of the femur and proximal part of the tibia was determined preoperatively and at six and twelve months postoperatively.

Results: In the control group, the bone mineral density showed significant decreases of 13.8% (p < 0.001) and 7.8% (p = 0.003) in the distal part of the femur and of 6.5% (p = 0.002) and 3.6% (p = 0.141) in the proximal part of the tibia at six and twelve months, respectively. In the study group, however, the bone mineral density showed significant increases of 10.0% (p = 0.010) and 1.9% (p = 0.049) in the distal part of the femur and of 9.4% (p < 0.001) and 5.4% (p = 0.032) in the proximal part of the tibia at six and twelve months, respectively. The overall differences in bone mineral density between the study and control groups were significant (p = 0.011 for the proximal part of the tibia, and p = 0.033 for the distal part of the femur).

Conclusions: We found significant postoperative decreases in bone mineral density in the distal part of the femur and proximal part of the tibia in women who had undergone total knee arthroplasty. Oral administration of alendronate for six months postoperatively significantly improved the bone mineral density. While the clinical benefits of alendronate after total knee arthroplasty remain unproven and the duration of follow-up in the present study was quite short, the improvement in bone mineral density may have a clinically important effect on prosthetic fixation and the rate of periprosthetic fractures after total knee arthroplasty.

Level of Evidence: Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). See Instructions to Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Chin-Jen Wang, M.D.
    Posted on April 26, 2004
    Dr Wang responds to Dr Alexandropoulos
    Chang Gung Memorial Hospital, Dept., Orthopedic Surgery, Kaohsiung, Taiwan 833

    We like to respond to the questions raised by Christos Alexandropoulos in reference to our recent article entitled "The effect of alendronate on bone mineral density ... after total knee arthroplasty" (2003;85:2121-6 Am). We did measure the BMD on the contralateral knee in this study. The BMD of the distal femur showed an increase of 11.6% +/- 22.2% in the alendronate group versus a decrease5.2% +/- 16.6% in the control group at 6 months. The BMD of the proximal tibia showed an increase of 6.3% +/- 26.5% in the alendronate group versus a decrease of 2.3% +/- 10/1% in the control group at 6 months. The data at one year postoperative were much lower.

    We also analysed the BMD data on the contralateral knees into two groups; one group with prior TKA and the other had no surgery. The BMD changes with or without prior TKA were very similar. Therefore, the BMD changes on the contralteral knees were similar to those noted on the operated knees in our study. We did not include the data on the contralateral knees because they were irrevelant to the goal of our study. We hope that we have adequately answered the questions and addressed the concerns.

    Ching-Jen Wang, M.D.
    Posted on April 21, 2004
    Dr. Wang responds:
    Chang Gung Memorial Hospital, Department of Orthopedic Surgery, Kaohsiung, Taiwan 833

    To the Editor:

    We like to respond to the questions raised by Dr.Alexandropoulos in reference to our recent article entitled "The effect of alendronate on bone mineral density ... after total knee arthroplasty" (2003;85:2121-6 Am). We did measure the BMD on the contralateral knee in this study. The BMD of the distal femur showed an increase of 11.6% +/- 22.2% in the alendronate group versus a decrease5.2% +/- 16.6% in the control group at 6 months. The BMD of the proximal tibia showed an increase of 6.3% +/- 26.5% in the alendronate group versus a decrease of 2.3% +/- 10/1% in the control group at 6 months. The data at one year postoperative were much lower.

    We also analysed the BMD data on the contralateral knees into two groups; one group with prior TKA and the other had no surgery. The BMD changes with or without prior TKA were very similar. Therefore, the BMD changes on the contralteral knees were similar to those noted on the operated knees in our study. We did not include the data on the contralateral knees because they were irrevelant to the goal of our study. We hope that we have adequately answered his questions and concerns.

    Christos Alexandropoulos
    Posted on April 06, 2004
    The Effect of Alendronate on Bone Mineral Density
    Trikala General Hospital

    To the Editor:

    Regarding the article “ The Effect of Aledronate on Bone Mineral Density in the Distal Part of the Femur and Proximal Part of the Tibia After Total Knee Replacement” (2003;85:2121-6) by CJ Wang et al, I would like to make some observations.

    In this study aledronate was administered in non osteoporotic patients and the increased Bone Mineral Content (BMC) of the operated tibia and femur that measured, considered that possibly improves the prosthetic fixation of the Total Knee Arthroplasty. This would be good news.

    But, surprisingly in this paper there are no data about the BMC increase of the non operated knee. Since aledronate has a systematic effect, one can expect an increased BMC in both knees and eventually on both hips. It is not clear how this iatrogenic alteration of BMC affects healthy major joints. For example, one can suppose that BMC increase may lead to subchondral sclerosis and rapid osteoarthritic degeneration of these joints.

    MM Petersen et al(1), investigating the effect of nasal salmon calcitonin on post-traumatic osteopenia following ankle fracture measured the BMC in both operated and healthy tibiae and and found a statistically significant increase on BMC in the healthy leg tibia.

    I believe that not only the improvement of the prosthetic components fixation but the effects of aledronate on the non osteoporotic patients’ major joints must be investigated in order the clinical importance of this study be evaluated. If the authors have obtained relative data the clinical follow up will be of great value.

    Yours sincerely

    Christos Alexandropoulos, MD Orthopaedic Department of Trikala General Hospital

    Reference: 1. Petersen MM, Lauritzen JM, Schwarz P, Lund B. Effect of nasal salmon calcitonin on post traumatic osteopenia following ankle fracture. A randomized double-blind placebo-controlled study in 24 patients. Acta Orthop Scand. 1998 Aug; 69(4): 347-50

    Corresponding address: Christos Alexandropoulos, MD 20, Triantafilou str., 42100 Trikala, Greece e-mail: alexand8@otenet.gr

    Ching-Jen Wang
    Posted on February 09, 2004
    Dr Wang responds:
    Chang Gung Memorial Hospital

    Dear Editor, This is to acknowledge the receipt of the letter to Editor from Tarja A. Soininvaara regarding our article. We would like to congratulate them on their study showing favorable effect of alendronate on periprosthetic bone, findings that are similar to our study. In their study, patients treated with alendronate plus calcium maintained distal femur BMD values close to the baseline, while patients who received only calcium showed significant bone loss during the one-year post TKA.

    The groups differed significantly in BMD in the metaphyseal and diaphyseal regions of interest. In their study, patients were allowed full weight bearing immediately after the operation, and the BMD was performed within one week, and at 3, 6, and 12 months postoperatively. In our study, the BMD was performed within one week preoperatively and at 6 and 12 months postoperatively. The geometries of the distal femur and the proximal tibia for BMD measurements were determined preoperatively. The same geometries were used for subsequent BMD measurements postoperatively. Thus, similar measurement areas can be secured and the values of measurement are reproducible.

    We have noted a wide range of BMD values among the patients. Therefore, we analyzed the results based on the mean ¡Ó SD values. In our study, patients were allowed to bear partial weight on the operated leg for 4 to 6 weeks before full weight bearing. In fact, the majority of patients were unable to bear full weight for approximately 4 weeks due to postoperative pain even though they were allowed to do so. Weight bearing may theoretically affect the BMD; however, short-term partial weight bearing (4 to 6 weeks) does not seem to cause any detrimental effect on BMD around the knee.

    The BMD measurement of the proximal part of the tibia was divided into three regions of interest (ROI): the lateral region (ROI-1), the medial region (ROI-2), and the center region (ROI-3). The medial and lateral regions were located at 1.0 cm within the cortex and 1.0 cm distal to the prosthesis-bone interface, and the center region was located at 1.0 cm distal to the prosthetic stem. We only used one type of prosthesis in this study, and the prosthesis-bone interface in the medial and lateral regions can be fair precisely estimated preoperatively. Likewise, the tip of the prosthesis stem can be determined accordingly. Such measurements can minimize or eliminate the effect of cement mantle on BMD values.

    The BMD values in the ROIs in Table IV are the average values of BMD measurement in anteroposterior and lateral projections. These regions were so chosen because they theoretically sustain the most stress shielding and the changes in BMD, if any, will most likely occur in these locations.

    Overall, we agree with the writer's opinions that there is a favorable effect of alendronate on periprosthetic bone after TKA. We like to thank the writer for his valuable opinions and comments.

    Ching-Jen Wang, M.D.

    Tarja A Soininvaara
    Posted on January 16, 2004
    The Effect of Alendronate on Bone Mineral Density in the Distal Part of the Femur and Proximal Part
    Savonlinna Central Hospital

    To The Editor:

    We read with great interest "The Effect of Alendronate on Bone Mineral Density in the Distal Part of the Femur and Proximal Part of the Tibia After Total Knee Arthroplasty" by Wang et al. (2003; 85-A:2121- 2126)(1).

    We have previously shown the efficacy of oral alendronate with calcium for the inhibition of early BMD loss after TKA in a prospective, randomized, one-year follow-up study. Periprosthetic BMD changes were measured in 19 patients with knee osteoarthrosis with dual-energy X-ray absorptiometry within a week post-operatively and at 3, 6 and 12 months follow-up. Patients treated with alendronate+calcium maintained distal femoral BMD values close to the baseline (from 0.48% to –5.5, P > 0.04), while patients receiving only calcium showed significant bone loss during the one-year (from –14.3% to –23.6%, P <0.015). The groups differed significantly in metaphyseal and diaphyseal regions of interests (ROI)(2). These ROIs are reproducible, with an average precision error ranging from 1.3% to 3.1% (3). Full weight-bearing was allowed immediately after the operation(2-4).

    The present study by Wang, et al., raises some questions. The authors used the preoperative BMD measurement as a baseline reference in their patients. We would like to know the reproducibility of their measurements. How did they verify that they measured the areas in the pre- and postoperative scans? What is the effect of the cement mantle and perioperative bone loss on these measurements? What was the duration and the effect of partial weight-bearing on BMD?

    The ranges of BMDs and their percent changes are very wide. Although the BMD increase at 6 months is marked (10 %) in the study group, the 12 months change may not be significant (1.9 %).

    According to both studies, alendronate treatment seems to prevent bone loss after TKA. The long-term effect of bisphosphonates in prevention of aseptic loosening needs to be investigated.

    Tarja A Soininvaara, M.D. and Heikki Kröger, M.D., Ph.D

    Department of Surgery, Savonlinna Central Hospital, Savonlinna, Finland. Department of Surgery, Kuopio University Hospital, Kuopio, Finland. Bone and Cartilage Research Unit (BCRU), University of Kuopio, Kuopio, Finland. Tarja.Soininvaara@uku.fi

    References

    1. Ching-Jen Wang, Jun-Wen Wang, Lin-Hsiu Weng, Chia-Chen Hsu, Chung- Cheng Huang, Chen. H-S 2003 The Effect of Alendronate on Bone Mineral Density in the Distal Part of the Femur and Proximal Part of the Tibia After Total Knee Arthroplasty. J Bone Joint Surg Am 85:2121-2126. 2. Soininvaara TA, Jurvelin JS, Miettinen HJ, Suomalainen OT, Alhava EM, Kroger HPJ. 2002 Effect of alendronate on periprosthetic bone loss after total knee arthroplasty: a one-year, randomized, controlled trial of 19 patients. Calcif Tissue Int. Dec;71(6):472-7. 3. Soininvaara T, Kroger H, Jurvelin JS, Miettinen H, Suomalainen O, Alhava E 2000 Measurement of bone density around total knee arthroplasty using fan-beam dual energy X-ray absorptiometry. Calcif Tissue Int Sep 67(3):267-72. 4. Soininvaara TA, Miettinen HJA, Jurvelin JS, Suomalainen OT, Alhava EM, Kroger HPJ. Periprosthetic femoral bone loss after total knee arthroplasty: one-year follow-up study of 69 patients. The Knee (In press).

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