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RCT
ACE Report #8396

Protein-Rich nutritional supplementation shows limited efficacy in elderly hip fractures


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Effects of protein-rich nutritional supplementation and bisphosphonates on body composition, handgrip strength and health-related quality of life after hip fracture: a 12-month randomized controlled study

BMC Geriatr. 2015 Nov 17;15(1):149

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Synopsis

79 elderly patients with femoral neck or trochanteric hip fractures were randomized to a group receiving protein-rich supplementation and weekly bisphosphonates, weekly bisphosphonates alone, or a control group; all three groups received calcium and vitamin D supplementation. The purpose of this randomized controlled trial was to compare these treatments in terms of their effect on body composition, hand-grip strength, and quality of life. The results displayed no significant differences between groups in body composition changes, hand-grip strength, or quality of life during the 1 year follow-up period. The quality of life decreased in all groups, most notably in the control and bisphosphonate groups.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Karolinska Institutet, EXPO funds from Stockholm County Council
Conflicts:
None disclosed

Risk of Bias

4.5/10

Reporting Criteria

17/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

3/4

Outcome Measurements

3/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

After a fracture of the hip, a significant proportion of patients are unable to return to their previous functional status. Muscle wasting and loss of strength (sarcopenia) often leads to a reduction in ambulatory capacity for the elderly, and may be due to protein malnutrition. The events surrounding fracture management are correlated with an increased loss of muscle mass from residual aging levels. Limited evidence was available indicating the benefits of protein and energy-rich nutritional supplements on body composition following hip fracture in the elderly, thus, the present study was conducted.

What was the principal research question?

How does the combination of protein-rich nutritional supplementation and bisphosphonates affect body composition, hand-grip strength, and quality of life following hip fracture in the elderly, assessed up to 1-year post-operatively?

Study Characteristics -
Population:
79 patients with a diagnosis of femoral neck or trochanteric fracture were included if they were 60 years of age or older without severe cognitive impairment, had a BMI less than 28 kg/m2, were living independently and were ambulatory prior to inclusion. Exclusion criteria were bisphosphonate treatment within a year, pathologic fracture, or bone metabolic disorder. All patients received calcium (1 g) and vitamin D (800 IU) divided into 2 daily doses for 12 months (69 completed).
Intervention:
Nutritional supplementation group: patients received a 200 ml package (Fresubin, Fresenius Kabi, Germany) twice daily for the first 6 months following fracture, each supplement package contained 20 g of protein and 300 kcal (i.e. 40 g and 600 kcal daily). In addition patients received 35 mg risedronate (Optinate Septimum, Sanofi, Germany) once weekly for 12 months (n=26, 18 completed; Mean age: 81 +/- 8; 7M/19F).
Comparison:
Bisphosphonate group: patients received only 35 mg risedronate weekly for 12 months (n=28, 25 completed; Mean age: 80 +/- 9; 10F/18M) Control group: patients received only calcium and vitamin D, as described above, for 12 months (n=25, 24 completed; Mean age: 78 +/- 11; 6M/19F)
Outcomes:
The primary outcome was body composition, measured by whole body dual-energy X-ray absorptiometry (DXA), and included lean mass (LM, muscle, visceral organs and water), fat mass (FM), and bone mineral content (BMC). The sum of LM and BMC represents the fat-free mass (FFM). Hand-grip strength (kg) was measured in the dominant hand by hand dynamometer (JAMAR 5030 J1, Sammons Preston, Roylan, USA). The occurrence of sarcopenia was defined as a combination of a low appendicular lean mass index and reduced hand-grip strength. Health-related quality of life was defined using the EQ-5D and biochemical markers were measured as well.
Methods:
RCT; multi-centered.
Time:
Assessments were made at baseline and 6 and 12 months postoperatively.

What were the important findings?

  • In the treatment group, 11 of 18 patients at final follow-up reported consuming only half of the prescribed intervention during the 6 months. No significant differences were noted between these patients and those who followed prescribed doses in total body mass, appendicular lean mass index, fat-free mass index, fat mass index, or hand grip strength at 6 and 12 months
  • An overall loss of body mass, fat-free mass, and fat mass occurred in all groups from baseline to both 6 and 12 months. Between-group differences in these losses were not significant (all p>0.05)
  • No significant differences were noted between groups in terms of fat-free mass index (FFMI), fat mass index (FMI), or appendicular lean mass index (alMl) at both 6 and 12 months (p>0.05), however a trend for an increased FMI and a greater drop in both FFMI and alMI was noted in the intervention group
  • Intention-to-treat analysis confirmed this trend, with no drop in the FMI of the intervention group at 6 months (p=0.01) and a significantly greater drop of FFMI in this group compared to the other two groups at both 6 and 12 months (p<0.001 and p=0.0006, respectively)
  • No significant differences were noted between groups in terms of hand grip strength (p>0.05), however, within the treatment group a significant increase in hand grip strength was noted during the first 6 months (p=0.04), but this result did not maintain significance at 12 months
  • Health-related quality of life decreased from 0.85 +/- 0.21 at baseline to 0.77 +/- 0.23 at 6 months and 0.74 +/- 0.23 at 12 months in all groups; no significant differences were noted between groups at any time point (p>0.05)
  • Significant decreases from baseline to 12 months were noted in the EQ-5D for the control and bisphosphonate groups (p=0.03 and p=0.01, respectively) but not for the intervention group (p=0.22)
  • No significant differences were noted between all groups at baseline or at 6 or 12-month follow-ups in terms of biochemical markers (p>0.05)

What should I remember most?

No significant differences were noted between hip fracture patients receiving protein-energy supplementation with bisphosphonates, bisphosphonates alone, or the control group in terms of the change in fat-free mass index, fat mass index, appendicular lean mass index, hand grip strength, or quality of life during the 1 year follow-up period. The quality of life decreased in all treatment groups, most notably in the control and bisphosphonate groups at 12 months.

How will this affect the care of my patients?

The results of this study displayed that protein-rich nutritional supplementation with bisphosphonates was unable to preserve lean mass more effectively than bisphosphonates or vitamin D and calcium alone in elderly patients with hip fracture. As well, no significant improvements in hand-grip strength or notable effects on quality of life were noted with supplementation. Further studies utilizing larger sample sizes are warranted to further determine if the within-group improvement in hand grip strength and quality of life with nutritional supplementation is noteworthy in clinical practice.

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