Health related quality of life in male patients with osteoporosis: results of a cross sectional study

Abstract

Introduction: Osteoporosis is one of the most common diseases affecting elderly persons. Male patients with osteoporosis have rarely been the focus of earlier studies. This study explores health related quality of life (HRQoL) indicators in a sample of German male patients with osteoporosis to determine potential avenues for clinical practice changes. Methods: This cross-sectional study describes two HRQoL indicators (EQ5D and QUALEFFO-41) in a sample of male patients being treated for osteoporosis. Questionnaires were sent to all male patients being treated at the Dresden University Hospital outpatient endocrine clinic. Of the 344 patients invited to participate in the study 155 (57.2%) were included. Results: Overall HRQoL EQ-5D-scores for male patients with osteoporosis were greater than those of comparable groups of the German population. Patients with ≥2 fractures had the highest level of impairment in HRQoL. Of all the dimensions of EQ-5D-scores, pain/discomfort was the most affected. Better HRQoL (median values <10.0/QUALEFFO-41 scores) were detected in the whole sample for jobs around the house, activities of daily living and mobility compared to other dimensions. The highest levels of impairment were observed in the QUALEFFO-41 domains of general health perception, mental function and pain. Conclusion: This analysis confirms the association between number of fractures and worse estimation of HRQoL in male patients. Because men are 3 times less likely to suffer from osteoporosis than women, the specific HRQoL characteristics of male patients with this disease can often be overlooked. Clinicians should consider mental health referral especially for osteoporotic male patients having experienced ≥2 fractures.

Keywords::

• EQ5D
• male patients
• osteoporosis
• quality of life
• QUALEFFO-41

Introduction

Osteoporosis is one of the most common endocrine-associated diseases affecting aging persons in Western Europe. The proportion of elderly people with this disease is increasing due to an overall increase in life expectancy. Advanced age (≥ 60 years) is an important risk factor for osteoporosis in addition to low BMI (< 20 kg/m²), weight loss, presence of other or previous osteoporotic fractures and individual health behaviour (physical activity, smoking, malnutrition [1,2]). Prevalence estimates for osteoporosis vary depending on the source and the method of data collection. In the German population, self-reported lifetime prevalence for osteoporosis is 11.9%. Women are 3 times more likely to suffer from osteoporosis than men (17.6% vs. 5.2% [3]).

Osteoporosis is characterised by low bone mineral density. This structural deterioration can lead to fractures, pain and functional disabilities. These conditions affect patients health related quality of life (HRQoL). HRQoL has become an important field of medical research in the last two decades. The goal of HRQoL research is to collect patient-reported outcomes data providing information on individual life situations and quality of life as affected by illness. The assessment of HRQoL is usually done by generic and disease-targeted instruments [4]. For patients with osteoporosis, six standardised questionnaires of varying methodology exist to collect disease specific HRQoL [5,6].

Most of the studies concerning HRQoL in patients with osteoporosis use either exclusively female samples [7–10] or mixed samples [11–13]. Most studies confirmed the association between osteoporosis and lower HRQoL measures in general, such that most of the patients with osteoporosis reported lower HRQoL [7,10] and this was most significantly seen in patients with osteoporotic fractures [9,11–14]. Studies describing the association of fracture location with HRQoL in females demonstrated that patients with lumbar region fractures had significantly lower HRQoL scores than those with thoracic fracture [9].

Male patients with osteoporosis have rarely been the focus of previous studies [15]. Most studies involving males with osteoporosis have addressed prevalence, life time risk and risk factors for osteoporosis-related fractures [16,17], or results of therapeutic interventions [18,19]. Little is known about gender specific health behaviour and social medical parameters in males suffering from osteoporosis [20]. Gender specific differences have been shown to be important for conditions such as heart disease. Evidence of gender specific differences in pain perception as well as HRQoL measures in general has also been demonstrated in previous studies [21]. Because HRQoL is an important adjunct to effective medical treatment, we explore whether any significant differences exist in HRQoL measures for male patient with osteoporosis compared to previously published studies of HRQoL measures for female cohorts with comparable levels of disease.

This cross-sectional study describes two specific HRQoL measures in a sample of male patients with osteoporosis under treatment at a University hospital endocrinology outpatient unit.

Methods

Study population

The endocrine specialty outpatient unit of the University Hospital of Dresden is one of the major centres in Saxony specialised in ambulatory treatment of endocrine diseases. In 2005, an invitation to participate in a HRQoL study was mailed to all male patients having been treated for osteoporosis between January 2000 and December 2005 (n = 344).

Inclusion/exclusion criteria

Osteoporosis was defined according to the World Health Organization (WHO)-criteria as a low bone mineral density (BMD T score <= −2.5 at lumbar/hip spine by DXA-measurement). Although all patients had both lumbar and hip DXA-measurements results documented in their charts, only lumbar spine measurements were used for analysis due to a significant proportion of patients with hip implants. Based on this 155 patients had diagnosis osteoporosis and were included in the analysis (See Figure 1).

Figure 1.  Flowchart describing the study sample of male patients with osteoporosis.

Data instruments

A three-part questionnaire was assembled for the purposes of our study. The first section included items related to sociodemographic data such as age, status of employment, body weight and height as well as characteristics of osteoporotic disease such as number and location of fragility fractures.

Two questionnaires were then included to investigate HRQoL: the generic EuroQoL-5D™ (EQ-5D) and the osteoporosis specific Quality of Life Questionnaire of the International Osteoporosis Foundation (QUALEFFO-41). EQ-5D is a standardised instrument for use as a measure of health outcome.

The QUALEFFO-41 includes 41 questions concerning the life situation of osteoporosis patients. Questions address pain, physical and mental function and general health and social function. All answers were scaled from 0 (best HRQoL) to 100 (worst HRQoL [12]).

The EQ-5D includes questions (dimensions) concerning mobility, self-care, usual activities, pain/discomfort and anxiety/depression (5 questions each topic), and an evaluation of general health state. Each dimension has 3 levels, scaled by 1 (no problem), 2 (some problems) and 3 (extreme problems). The additional EQ5D-scale INDEX is scaled from 0 (worst imaginable health state) to 100 (best imaginable health state). Both questionnaires have been standardized and are valid, reliable and the most frequently used tools for assessing HRQoL in patients with osteoporosis [9–11,22].

Data collection

The questionnaire was mailed by post to all male patients being treated for osteoporosis. Participation was voluntary and without incentives. All items were reported by patients themselves. Of the 344 patients who received the questionnaire, 271 (78.5%) agreed to participate and anonymously completed and returned the questionnaire.

Data analysis

For the analysis, we included osteoporosis patients both with and without fragility fractures (n = 155). Data was recorded and analysed using SPSS 16.0. In addition to the descriptive analysis, bivariate correlations and group comparisons were conducted. Three subgroups were identified of the total sample for group comparison: (1) patients without fractures, (2) patients with one fracture and (3) patients with two or more fractures.

Distribution of data was tested by Kolmogorov-Smirnov-Test. Based on the non-normal distribution of the study data, non-parametric tests were used. To analyse significant differences between the three subgroups, the Mann-Whitney-U-Test (U-Test) and the Kruskal-Wallis-Test (K-W-Test) were used. To test correlations of ordinally scaled data, the Spearman rank correlation was used.

Results

Study cohort

Socio demographic characteristics and clinical parameters

The median age of the total sample was 60.9 years. 42.9% of the respondents reported employment at the time of the survey; 51.0% were retired. There were no significant differences between the fracture subgroups concerning age, employment and retirement status when compared to the total sample (Table I). 25.8% of the employed patients reported incapacity to work for a minimum of 3 weeks in the past 12 months. Mean Body Mass Index (BMI) of the total sample was at 25.1 kg/m² (+/− 4.3 s.d.). 54.6% of the patients were overweight (BMI ≥ 25 kg/m²) and 8.6% underweight (BMI < 20 kg/m²). Differences in BMI among the fracture subgroups were not significant (Table I).

Table I.  Characteristics of the sample and fracture subgroups in male patients with osteoporosis (n = 155).

Demographic parameters	Statistics	Total sample (n = 155)	No fractures (n = 95)	1 fracture (n = 36)	≥ 2 fractures (n = 24)	Stat. tests/group differences
Age in years	Median	60.9	60.9	61.1	58.2	p > 0.05^b
Employed	n (%)	42.9	46.3	34.3	41.7	p > 0.05^c
Retired	n (%)	51.0	47.4	63.8	45.8	p > 0.05^c
BMI (kg/m^2)	mean ± s.d.	25.1 ± 4.3	24.6 ± 3.4	25.0 ± 3.9	27.0 ± 7.0	p > 0.05^b
Fracture type^a
Lumbar/vertebrae	n (%)	32.3	0	83.3	83.3	p > 0.05^c
Hip	n (%)	7.1	0	5.6	37.5	p ≤ 0.01^c
Forearm	n (%)	9.0	0	11.1	41.7	p ≤ 0.01^c

^aSubjects may have experienced more than one main fragility fracture, n (%) = number of patients with fractures, test of group differences only between 1 fracture vs. ≥ 2 fractures

^bKruskall-Wallis-test.

^cChi²-test.

Presence of fracture

38.7% of the total sample reported one or more fragility fractures (Table I). Of the 85 participants reporting fragility fractures, 70.6% were located at the lumbar vertebrae, 16.5% at forearm and 12.9% near the hip. The majority of the single fractures (83.3%) were reported at lumbar vertebrae field (n = 36). Patients with two or more fractures were significantly more likely to have fractures located at forearm or hip compared to patients with only one fracture (Table I). Fracture location and number of fragility fractures were not correlated with participant age (Chi²-Test/p > 0.05).

Health related quality of life

Regarding results of the EQ-5D, more than two-thirds of the total sample reported no limitations in HRQoL except for the dimension of pain/discomfort. A minor proportion of the total sample had extreme ailments (Table II).

Table II.  Percentage of frequency (n) of the dimensions of EQ-5D in male patients with osteoporosis (n = 155).

	Ailments	No fractures (n = 95)	1 fracture (n = 36)	≥ 2 fractures (n = 24)	rspearman (p)
Mobility (n = 155)	No	80.0% (76)	77.8% (28)	58.3% (14)	0.144 (p > 0.05)
	Moderate	20.0% (19)	22.2% (8)	41.7% (10)
	Extreme	–	–	–
Self-care (n = 154)	No	95.8% (90)	97.2% (35)	87.5% (21)	0.083 (p > 0.05)
	Moderate	4.3% (4)	2.8% (1)	12.5% (3)
	Extreme	–	–	–
Usual activities (n = 155)	No	82.1% (78)	77.8% (28)	62.5% (15)	0.142 (p > 0.05)
	Moderate	16.8% (16)	22.2%(8)	37.5% (9)
	Extreme	1.1% (1)	–	–
Pain/discomfort (n = 155)	No	32.6% (31)	19.4% (7)	12.5% (3)	0.225 (p ≤ 0.01)
	Moderate	62.1% (59)	77.8% (28)	62.5% (15)
	Extreme	5.3% (5)	2.8% (1)	25.0% (6)
Anxiety/depres-sion (n = 155)	No	67.4% (64)	75.0% (27)	50.0% (12)	0.057 (p > 0.05)
	Moderate	29.5% (28)	25.0% (9)	45.8% (11)
	Extreme	3.2% (3)	–	4.2% (1)

Analysis of the QUALEFFO-41 brought more differentiated outcomes concerning the individual domain-scores depending on subgroup. Lower median values (<10.0) in the QUALEFFO-41 scores (scaling from 0 = best HRQoL up to 100 = worst HRQoL) were detected in the majority of the sample for jobs around the house, activities of daily living and mobility. Comparing the different dimensions of QUALEFFO-41, the highest limitations of HRQoL (median values ≥30.0) were observed in the domains of general health perception, mental function and pain (Figure 2). Limitations of HRQoL have varied depending on subgroup.

Figure 2.  Description of the QUALEFFO-41-domain-scores in male patients with osteoporosis (n = 150)*.

Scaling: 0 = no to 100 = high limitation.

*5 patients with missing values

Male patients without fracture

For the EQ-5D, the majority of patients without fracture (>80%) reported no ailments with regards to mobility, self-care and usual activities. 67.4% confirmed moderate or extreme ailments for pain/discomfort and 32.7% in anxiety/depression (Table II). Median (74.5) of the summarised EQ-5D-scale INDEX showed less limitations (value of INDEX >70) of HRQoL in at least half of this subgroup (Table III).

Table III.  Values of the summarized EQ-5D-Scale INDEX in male patients with osteoporosis (n = 155).

	INDEX
No fractures
Mean ± s.d.	74.5 ± 17.8
Median	72.8
n	95
Max. 1 fracture
Mean ± s.d.	72.8 ± 13.2
Median	72.8
n	36
Min. 2 fractures
Mean ± s.d.	61.3 ± 16.4
Median	67.7
n	24
Total sample
Mean ± s.d.	72.1 ± 17.2
Median	72.8
N	155
Results K-W-Test
chi^2 (p)	7.88 (≤ 0.05)

For the QUALEFFO-41, the lowest mean values were found for physical function (5.9) and social function (23.6). Stronger limitations were reported for QUALEFFO-41-scores pain (30.0), mental function (33.3) and general health perception (50.0) than for the EQ-5D-scale.

Male patients with one fracture

Male patients with one fractures shared similarities to the subgroup without fractures in both EQ-5D and QUALEFO ratings. Most patients with a single fracture reported no ailments for EQ-5D-dimensions mobility (77.8%), self-care (97.2%) and usual activities (77.8%). 80.6% reported moderate or extreme in the EQ-5D-dimension pain/discomfort and 25.0% reported moderate ailments in anxiety/depression (Table II). The median value of the EQ-5D-scale INDEX was 72.8 in this subgroup (Table III).

Mean values of the QUALEFFO-41-scores were nearly similar to the subgroup without fracture (Table IV).

Table IV.  Mean values of the QUALEFFO-41-scores in male patients with osteoporosis (n = 155).

	Pain^a	Physical function^b	Social function^a	General health perception^a	Mental function	Total score
No fractures	30.0	5.9	23.6	50.0	33.3	21.1
1 fracture	30.0	7.4	26.1	50.0	32.0	24.4
≥ 2 fractures	47.5	17.6	39.7	66.7	41.7	25.7
Total sample	30.0	7.4	26.1	50.0	33.3	22.1

Scaling of the values: 0 = unlimited to 100 = strongly limited quality of life.

K-W-Test: ^ap ≤ 0.05/ ^bp ≤ 0.01.

Male patients with two or more fractures

Patients with two or more fractures reported a greater number of ailments in all EQ-5D-dimensions than the subgroups with none or one fracture. The vast majority (87.5%) confirmed ailments for pain/discomfort and 50.0% reported ailments in anxiety/depression (Table II). The median value of the EQ-5D-scale INDEX was 61.3 for this subgroup (Table III).

Mean values concerning QUALEFFO-41-scores were also higher than in the subgroups with none or one fracture. Highest values were observed in the scores general health perception (66.7), pain (47.5) and mental function (41.7).

Subgroup comparison

The differences concerning the summarized EQ-5D scale INDEX among the fracture subgroups were significant (p ≤ 0.05, Table III). The correlation between number of fractures and extent of disorder was significant for the EQ-5D dimension of pain/discomfort (p ≤ 0.01, Table II).

When comparing QUALEFFO-41-scores among subgroups, highly significant differences in physical function were observed. The greater number of fractures correlated with worse perception of HRQoL (Table IV).

The QUALEFFO-41 scores correlated strongly and high significantly (r > 0.5/p ≤ 0.001) with compatible dimensions of EQ-5D.

Discussion

This analysis confirms the association between number of fractures and worse estimation of HRQoL seen in previous studies [9,11–14]. Pain/discomfort was the most affected dimension of HRQoL. The predominant impact of osteoporosis on the pain/discomfort dimension of HRQoL has also been shown to exist in female patients and is well documented in the literature [7,11]. The highly significant correlation of the matching scores for the two standardised questionnaires EQ-5D and QUALEFFO-41 cross-validate these results.

Association between osteoporotic-related conditions and mental health

When comparing our data to a representative sample of German male adults in the European Study of the Epidemiology of Mental Disorders (ESEMeD [23]) which also used the EQ-5D, we observed the following: there were consistently more moderate to extreme problems in all five EQ-5D-dimensions in our sample of osteoporosis patients than in the ESEMeD sample; and the most impacted HRQoL indicators (independent of age) were reported for the dimensions of pain/discomfort and anxiety/depression. This highlights the potential association between osteoporotic-related conditions and mental health.

Studies with a mixed or exclusively female population of osteoporotic patients have also reported pain/discomfort to be the most constraining dimension when compared to other EQ-5D-dimensions [9,11].

We find some similar results in the measures of the QUALEFFO-41 compared to female samples [7,10]. Stronger burdens were detected for the QUALEFFO-41 scores for pain, general health perception, mental and social function, independent of age. In addition, a study by Cockerill et al. using the QUALEFFO-41 also found the strongest impact of disease on general health perception, social and mental function in both female and male patients (aged 50 years and over [11]). However, these studies found considerably higher values for adverse effects in the HRQoL scores when compared to our study. This could be due to the specific constitution of our sample of patients treated at the outpatient endocrine unit.

There were no significant differences among sub-groups when considering the value of mental function-scores in relation to the number of fractures. This is in agreement with the findings of Adachi et al. also showing no differences between fracture event and mental health (measured by SF-36^®) for the examined male participants (aged 50 years and older [24]).

Our data confirmed that chronic conditions such as osteoporosis are associated with adverse effects on mental health. Because women are three times more likely to suffer from osteoporosis than their male counterparts, men with this disease can often be overlooked. In addition, male patients have a different way of perceiving their disease than females. With regards to gender specific perceptions and mental health behaviours in men, male osteoporosis patients seem to be a group with high risk for mental health conditions. Based on this, treatment of osteoporosis in male patients should include a screening of their subjective disease perception and assessment of their coping mechanisms. For patients who experience a lower health-related quality of life as a result of their osteoporotic disease, measures such a psycho-social counselling, referral to patient support groups and outreach programs should be provided as part of a comprehensive clinical treatment program.

Association between numbers of fractures on HRQoL

The HRQoL of the male patients in our study worsened noticeably with an increase in fracture number: male patients with none or one fracture often showed similar score values, whereas patients with two and more fractures showed significantly worse HRQoL. In contrast to these findings, the study of a female sample by Oleksik et al. showed significant progressive changes of HRQoL in women with one or more osteoporotic fractures compared to women without fractures [9]. The HRQoL measures in our sample of male patients seems to have been more severely affected as a consequence of the second osteoporotic fracture than in the Oleksik study with female patients. According to this, our data points to the importance of avoiding further and multiple pathologic fractures in order to preserve patients’ subjective quality of life. As reported in the literature [6,18,25,26], the relation between fractures and increased morbidity and mortality in osteoporosis patients supports the demand for fracture prevention from a clinical standpoint. Additionally, Randell et al. have described the effects of immobility caused by declines in body function and greater risk for social isolation. Mental and emotional health are also affected by deterioration in physical ability [27]. The support in finding satisfactory coping strategies concerning osteoporosis and fracture events should be a part of the treatment. Lastly, fracture prevention can decrease intangible health costs by preserving of quality of life [9] and patient independence.

The direct health costs caused by medical treatment and care of additional fractures, as well as indirect health costs caused by non-productive work-time could at least in part be saved by targeted fracture prevention [28]. This is essential for female as well as for male patients. Besides systemic treatments to stabilise or re-establish bone mass, the prevention of falls as a high risk factor for additional fractures is important.

Limitations of the study

Although we attempted to limit bias in our study, the following limitations must be mentioned. Our patient sample is unlikely to represent the general osteoporotic patient population in Germany because it is drawn from a university specialty clinic. Based on our results, there could be a selection bias: the patients visiting our outpatient unit were more likely to be less deteriorated in physical function, mobility and self-care. However, comparable samples (mixed and female patients with osteoporosis of similar age groups) using the QUALEFFO-41 or the EQ-5D showed visibly stronger deterioration in these HRQoL domains. Because the study was based on voluntarily participation results might be affected by response bias.

There is no data on co-morbid conditions or concurrent diseases that could have also affected HRQoL. Since the self-reported data concerning these issues would have been vague and affected by recall bias, we did not collect this in our survey. Consequently, we could not detect differences in HRQoL caused by these features.

The size of the sample (n = 155) allowed at most the measuring of moderate correlation effects in sub-groups (regarding drop outs). We could not analyse the impact of the location of fractures on HRQoL because of the very small subgroups. Examining these relationships would be interesting for further studies.

Conclusion

Our study, male patients with osteoporosis responded in overall more to be affected in HRQoL than comparable groups of the German population. Especially male patients with two or more fractures had the highest level of impairment in HRQoL.

Because men are 3 times less likely to suffer from osteoporosis than women, the specific characteristics associated with male patients can often be overlooked. Clinicians should consider mental health screening and referral when necessary for osteoporotic male patients having experienced two or more fractures. They should also focus targeted fracture prevention efforts for patients without or with a single fracture.

Further research is needed to analyse gender specific differences in perception of health and pain as well as in coping strategies in osteoporotic men.

Declaration of Interest: The authors report no conflicts of interest.