Improvement in Health-related Quality of Life in Osteoporosis Patients
Improvement in Health-related Quality of Life in Osteoporosis Patients
Background: Individuals with osteoporosis and recent vertebral fractures suffer from pain and impaired health-related quality of life (HRQL). To determine whether patients with osteoporosis treated with teriparatide experienced improvement in HRQL and pain symptoms after several months of therapy.
Methods: We retrospectively studied a sample of osteoporosis patients treated with teriparatide in a Canadian rheumatology practice. We included patients that received teriparatide therapy with baseline and follow-up Mini-Osteoporosis Quality of Life Questionnaire (OQLQ) data. Follow-up data was measured at three or six months. We used a paired Student's t-test to compare baseline and follow-up measurements for each of the questionnaire's ten questions (five domains). Statistical analysis was also repeated to only include patients who suffered a prior vertebral fracture.
Results: 57 patients were included in the study, including 47 women. The mean age was 63.8 years (standard deviation 12.1 years). About sixty five percent (37/57) had previously sustained one or more osteoporotic fractures and about 38.6% (22/57) had suffered a prior vertebral fracture. About 44% (25/57) of individuals were taking one or more types of pain medications regularly prior to starting therapy. At follow-up, significant improvements were observed in the OQLQ domains of pain symptoms. This was seen when all patients on teriparatide were included, and also when only patients with prior vertebral fractures were included. There was also an improvement in emotional functioning, relating to fear of falling at 3 months follow-up (p = 0.019). Respondents also reported improvement in the domain of activities of daily living, relating to vacuuming at 6 months follow-up (p = 0.036), and an improvement in the leisure domain, relating to ease of traveling in the prior vertebral fracture population at 3 months follow-up (p = 0.012). However, there was no significant improvement observed in the domains of physical functioning. Participants also reported a decrease in need for pain medications, with 26% (15/57) requiring analgesics at the time of follow-up.
Conclusion: Teriparatide use may be associated with improvements in HRQL in osteoporosis patients, in particular alleviation of pain symptoms. These results were especially evident in patients with a history of vertebral fractures. These findings should be confirmed in larger prospective studies with a suitable control group.
Osteoporosis is a disease leading to progressive decreases in bone mineral density, decreased bone strength and increased risk of skeletal fractures. Approximately 30% of women will have sustained at least one vertebral fracture by the age of 75. There are over 700,000 incident vertebral fractures related to osteoporosis each year in the United States. Both clinical and radiographical fractures are associated with an increase mortality rate. One study identified a 16% reduction in expected 5 year survivability. Approximately 75% of patients who present with a clinical vertebral fracture will experience chronic pain. Back pain due to vertebral fractures has a significant impact on osteoporotic patients. The number and severity of vertebral fractures also increases the risk of developing chronic back pain. This has a significant impact on quality of life and functional impairment on the affected patients.
Conventional treatments for osteoporosis, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin and estrogen, have been shown to reduce the rate of bone resorption and preserve bone mass. However, none of these have been shown to stimulate new bone formation. Teriparatide [recombinant human PTH-(1–34)] is an agent shown to increase both bone mass and bone strength. In the Fracture Prevention Trial (FPT), teriparatide was shown to increase lumbar spine and femoral neck BMD and decreased fracture risk of both vertebral and non-vertebral fractures in post-menopausal women with osteoporosis. Aside from its effect on BMD, teriparatide also had a positive effect on the non-BMD determinants of bone strength.
In the FPT trial comparing the effect of Teriparatide 20 μg/day to placebo in post-menopausal women, the incidence of back pain was 17% in the treatment group, and 23% in the placebo group. Teriparatide's role in preventing back pain in osteoporotic patients was assessed through a meta-analysis of four completed, randomized, double-blinded trials of teriparatide versus a comparator. Nevitt and colleagues reported the teriparatide-treated group had a significant reduction in new or worsening back pain versus comparators (RR 0.73, 95% CI 0.61 to 0.87), over a time period encompassing the clinical trial plus 30 months of post-treatment follow-up assessment.
The goal of this study is to determine whether patients in every day clinical practice with osteoporosis, treated with teriparatide, experienced improvement in HRQL and pain symptoms after several months of therapy in a clinic setting. Measuring only pain scores for these patients would be insufficient, because aside from acute and chronic back pain, patients with vertebral fractures also suffer from impaired activities of daily living, anxiety and constant fear about falling and suffering another fracture. A follow-up Mini-Osteoporosis Quality of Life Questionnaire (OQLQ) was used to quantify the patient's pain and impact on quality of life. This is primarily an exploratory study whose sample size is determined by the available data. In addition, this is the first study to compare patient's HRQL data in pre and post-teriparatide therapy.
Background: Individuals with osteoporosis and recent vertebral fractures suffer from pain and impaired health-related quality of life (HRQL). To determine whether patients with osteoporosis treated with teriparatide experienced improvement in HRQL and pain symptoms after several months of therapy.
Methods: We retrospectively studied a sample of osteoporosis patients treated with teriparatide in a Canadian rheumatology practice. We included patients that received teriparatide therapy with baseline and follow-up Mini-Osteoporosis Quality of Life Questionnaire (OQLQ) data. Follow-up data was measured at three or six months. We used a paired Student's t-test to compare baseline and follow-up measurements for each of the questionnaire's ten questions (five domains). Statistical analysis was also repeated to only include patients who suffered a prior vertebral fracture.
Results: 57 patients were included in the study, including 47 women. The mean age was 63.8 years (standard deviation 12.1 years). About sixty five percent (37/57) had previously sustained one or more osteoporotic fractures and about 38.6% (22/57) had suffered a prior vertebral fracture. About 44% (25/57) of individuals were taking one or more types of pain medications regularly prior to starting therapy. At follow-up, significant improvements were observed in the OQLQ domains of pain symptoms. This was seen when all patients on teriparatide were included, and also when only patients with prior vertebral fractures were included. There was also an improvement in emotional functioning, relating to fear of falling at 3 months follow-up (p = 0.019). Respondents also reported improvement in the domain of activities of daily living, relating to vacuuming at 6 months follow-up (p = 0.036), and an improvement in the leisure domain, relating to ease of traveling in the prior vertebral fracture population at 3 months follow-up (p = 0.012). However, there was no significant improvement observed in the domains of physical functioning. Participants also reported a decrease in need for pain medications, with 26% (15/57) requiring analgesics at the time of follow-up.
Conclusion: Teriparatide use may be associated with improvements in HRQL in osteoporosis patients, in particular alleviation of pain symptoms. These results were especially evident in patients with a history of vertebral fractures. These findings should be confirmed in larger prospective studies with a suitable control group.
Osteoporosis is a disease leading to progressive decreases in bone mineral density, decreased bone strength and increased risk of skeletal fractures. Approximately 30% of women will have sustained at least one vertebral fracture by the age of 75. There are over 700,000 incident vertebral fractures related to osteoporosis each year in the United States. Both clinical and radiographical fractures are associated with an increase mortality rate. One study identified a 16% reduction in expected 5 year survivability. Approximately 75% of patients who present with a clinical vertebral fracture will experience chronic pain. Back pain due to vertebral fractures has a significant impact on osteoporotic patients. The number and severity of vertebral fractures also increases the risk of developing chronic back pain. This has a significant impact on quality of life and functional impairment on the affected patients.
Conventional treatments for osteoporosis, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin and estrogen, have been shown to reduce the rate of bone resorption and preserve bone mass. However, none of these have been shown to stimulate new bone formation. Teriparatide [recombinant human PTH-(1–34)] is an agent shown to increase both bone mass and bone strength. In the Fracture Prevention Trial (FPT), teriparatide was shown to increase lumbar spine and femoral neck BMD and decreased fracture risk of both vertebral and non-vertebral fractures in post-menopausal women with osteoporosis. Aside from its effect on BMD, teriparatide also had a positive effect on the non-BMD determinants of bone strength.
In the FPT trial comparing the effect of Teriparatide 20 μg/day to placebo in post-menopausal women, the incidence of back pain was 17% in the treatment group, and 23% in the placebo group. Teriparatide's role in preventing back pain in osteoporotic patients was assessed through a meta-analysis of four completed, randomized, double-blinded trials of teriparatide versus a comparator. Nevitt and colleagues reported the teriparatide-treated group had a significant reduction in new or worsening back pain versus comparators (RR 0.73, 95% CI 0.61 to 0.87), over a time period encompassing the clinical trial plus 30 months of post-treatment follow-up assessment.
The goal of this study is to determine whether patients in every day clinical practice with osteoporosis, treated with teriparatide, experienced improvement in HRQL and pain symptoms after several months of therapy in a clinic setting. Measuring only pain scores for these patients would be insufficient, because aside from acute and chronic back pain, patients with vertebral fractures also suffer from impaired activities of daily living, anxiety and constant fear about falling and suffering another fracture. A follow-up Mini-Osteoporosis Quality of Life Questionnaire (OQLQ) was used to quantify the patient's pain and impact on quality of life. This is primarily an exploratory study whose sample size is determined by the available data. In addition, this is the first study to compare patient's HRQL data in pre and post-teriparatide therapy.
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