Alendronate in the Prevention of Collapse of the Femoral Head in Nontraumatic Osteonecrosis



Fig. 36.1
Comparison of alendronate and placebo




Table 36.1
Radiographic evaluation (University of Pennsylvania System)






































































Fosamax

Stage

0

I

IIC

IIIC

IV

V and VI

THA

Baseline



20

12




Follow-up

0

0

11

11

9

1

4

Placebo

Stage

0

I

IIC

IIIC

IV

V and VI

THA

Baseline



25

8




Follow-up

1

0

14

9

9

0

5



Table 36.2
MRI evaluation and Harris Hip Score

















































% of the area of osteonecrosis in femoral head

Alendronate (N)

Placebo (N)

p-valuea

Baseline

47.0 ± 19.4 (32)

45.8 ± 19.4 (30)

0.6262

End of study/THA/withdrew

37.9 ± 19.9 (26)

38.8 ± 16.6 (22)

0.8920

Difference

−6.6 ± 11.9 (26)

−6.6 ± 13.9 (19)

0.5170

95 % C.I.

−11.4 to −1.8

−13.3–0.1
 

Harris Hip Score (subject no.)

26

26
 

Baseline

78.1 ± 12.5

76.6 ± 15.2

0.6804

Follow-up

79.3 ± 14.2

83.8 ± 12.8

0.2435


aThere is no statistical significance in any item between two groups



Table 36.3
Short Form-36










































































































































































Dimension

Alendronate

Placebo

p-valuea

N

31
 
28
   

Baseline

Mean ± SD

Medium

Mean ± SD

Medium
 

Physical functioning

60.3 ± 24.8

60.0

58.0 ± 28.1

55.0

0.7388

Role limitation due to physical problem

46.0 ± 40.4

50.0

50.9 ± 44.9

62.5

0.6588

Bodily pain

58.5 ± 20.5

57.5

56.6 ± 24.2

62.5

0.7401

General health

56.0 ± 17.8

55.0

53.4 ± 20.5

55.0

0.6074

Vitality

60.5 ± 20.3

55.0

52.3 ± 23.7

52.5

0.1598

Social functioning

70.2 ± 24.7

75.0

65.6 ± 26.3

68.8

0.4972

Role limitation due to emotional problem

58.1 ± 44.7

66.7

60.7 ± 43.6

83.3

0.8188

Mental health

65.5 ± 17.0

68.0

61.6 ± 21.5

64.0

0.4310

Total score

59.2 ± 18.6

55.9

57.0 ± 21.9

60.1

0.6788

N

30
 
28
   

The end of study/THA/withdrew

Mean ± SD

Medium

Mean ± SD

Medium
 

Physical functioning

55.0 ± 26.2

52.0

56.1 ± 27.2

55.0

0.8742

Role limitation due to physical problem

37.5 ± 43.4

0.0

38.4 ± 42.7

12.5

0.9374

Bodily pain

58.1 ± 20.4

57.5

63.3 ± 18.6

67.5

0.3140

General health

51.0 ± 20.4

45.0

50.8 ± 23.8

50.0

0.9731

Vitality

53.5 ± 18.1

50.0

54.8 ± 20.1

52.5

0.7931

Social functioning

64.2 ± 20.2

68.8

63.8 ± 24.4

50.0

0.9556

Role limitation due to emotional problem

50.0 ± 47.7

50.0

53.6 ± 46.6

62.5

0.7743

Mental health

60.7 ± 15.9

60.0

61.1 ± 19.5

60.0

0.9189

Total score

53.3 ± 20.2

53.7

54.7 ± 21.9

61.3

0.8011





































































Difference of dimension

Alendronate

Placebo

p-valuea

N

30

28
 
 
Mean ± SD

Mean ± SD
 

Physical functioning

−5.8 ± 26.3

−1.9 ± 30.8

0.6024

Role limitation due to physical problem

−10.0 ± 43.8

−12.5 ± 45.4

0.8318

Bodily pain

−1.3 ± 21.2

6.7 ± 22.4

0.1656

General health

−5.8 ± 19.8

−2.6 ± 22.6

0.5621

Vitality

8.5 ± 18.9*

2.5 ± 18.2

0.0288

Social functioning

−7.9 ± 21.4

−1.7 ± 20.6

0.2718

Role limitation due to emotional problem

−10.0 ± 51.9

−7.1 ± 39.9

0.8160

Mental health

−5.8 ± 17.4

−0.42 ± 14.4

0.2027

Total score

6.9 ± 19.3*

−2.2 ± 15.4

0.3137


*p < 0.05, tested by Signed Rank test

aTested by Wilcoxon Rank sums test


Our primary goal was to evaluate whether Aln can decrease the need for THA. Both surgical and nonsurgical approaches have been developed to preserve the joint and are used in an attempt to arrest the progression of disease, as well as to offer pain relief [39, 40]. Maintenance of the femoral head shape and articular surface, and halting the progression of the disease, appears to be one of the preferred methods of avoiding arthrosis of the hip joint. Surgical treatments with osteotomies and/or bone grafts that restore and revive the femoral head provide excellent long-term results [1, 39, 4143]. Medication that prevents the early collapse of the osteonecrotic femoral head is an attractive treatment. Using Aln in an attempt to slow down the bone remodeling process had been reported by Lai et al. [11]. In a randomized, control, prospective study, they showed the effectiveness of Aln in delaying or even avoiding THA in pre-collapse femoral heads. In the study by Agarwala et al., THA was circumvented with early use of Aln in pre-collapse femoral heads [10, 13]. In terms of our primary goal, the result was different from the above studies [11, 13]. We did not find any obvious effect of Aln in decreasing the possibility of receiving THA. Hip arthroplasty for ON is dependent on the patient’s pain severity and functional needs; therefore, the disease status and the functional demand of the patient are very important factors in terms of treatment options. It is important that any decision to perform arthroplasty should be supported by robust clinical information. A double-blind design is very important because the disease course sometimes involves subjective judgment by the investigator and the expectations of individual patients when making decisions concerning undergoing surgical treatment. No standard criteria for the timing of surgical treatment have been defined. A meta-analysis of the outcomes of protected weight bearing in 819 patients demonstrated a failure rate of >80 % at a mean of 34 months [44]. Even though all patients had a large lesion (>30 %) in our study, we found a very low incidence of THA (13.06 % in the Aln group and 15.60 % in the placebo group) due to the collapse of the femoral head, as compared with the previous literature [1, 40, 4448]. In our study, all patients received daily oral calcium (500 mg) and vitamin D (400 IU). There is no report about the therapeutic effects of calcium and vitamin D. We are not certain of the reasons for the low incidence of THA and progression of disease in the placebo group. Because there is no data about the natural course of ON in the Taiwanese population, we are not certain as to whether there might be a racial difference in the natural course of ON. As such, there was a numerical reduction in the rate of THA in the Aln group compared with placebo that did not achieve statistical significance; this was likely because the study was originally designed to detect a between-group difference based on event rates of 35.7 % (10/28) and 3.4 % (1/29) in the placebo and Aln groups, respectively.

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Mar 18, 2017 | Posted by in GENERAL RADIOLOGY | Comments Off on Alendronate in the Prevention of Collapse of the Femoral Head in Nontraumatic Osteonecrosis

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