approximately 30% of women have sustained at least 1 vertebral fracture by the age of 75 .
these fractures are an important and common cause of morbidity in osteoporotic patients ; moreover , fractures evidenced both clinically and at radiographic examination are associated with an increased mortality rate .
back pain owing to vertebral fractures has a significant affect on osteoporotic patients [ 46 ] , and the number and severity of these fractures also increases the risk of developing chronic back pain .
this has a marked negative impact on the quality of life ( qol ) and functional impairment of the affected patients .
conventional treatments for osteoporosis including bisphosphonates , selective estrogen receptor modulators ( serms ) , and estrogen have been shown to reduce the rate of bone resorption and to preserve bone mass .
another therapeutic option includes rhpth , an agent that has been shown to increase both bone mass and bone strength .
when injected , teriparatide ( rdna origin ) , the amino - terminal fragment of human pth ( rhpth 134 ) , is a potent bone formation agent for the treatment of severe osteoporosis .
it increases osteoblast production / growth and prevents osteoblast apoptosis ; at the same time , it enhances absorption of calcium from the intestine , renal reabsorption of calcium , while decreasing the excretion of phosphates in the kidney [ 1114 ] .
when administered once daily by subcutaneous injection , rhpth increases bone density and improves trabecular architecture , cortical geometry , and strength .
not only does rhpth increase trabecular bone density by stimulating bone formation , but it also stimulates osteoclastic bone resorption [ 1719 ] . in several studies , rhpth has been shown to increase bone mineral density in postmenopausal osteoporosis , in senile osteoporosis in men , and in glucocorticoid - induced osteoporosis .
teriparatide acts via the pth-1 receptor on osteoblasts and bone marrow stromal cells to induce osteoblastic bone formation , that is , osteoid synthesis and accelerated mineralization .
this , in turn , results in reductions in skeletal fractures to levels equivalent to , or over , those obtained by using antiresorptive agents .
the increase in bone mineral density induced by rhpth is substantial , ranging 10% to 15% over 2 to 3 years in most studies [ 10,2024 ] . moreover , rhpth can cause demonstrable increases in bone mineral density and changes in markers of bone turnover within 3 months since the start of treatment .
quality of life ( qol ) can be measured to compare the effect of different treatments for osteoporosis .
measuring pain scores only for these patients would be inadequate , because apart from acute and chronic back pain , patients with vertebral fractures also experience anxiety , constant fear of falling , or suffering another fracture while their daily living activities are impaired .
most information has been collected thanks to the efforts made by some researchers to develop specific instruments to test the physical and emotional disability generated by the disease .
generic tools available for measuring qol are useful to evaluate general health but they lack disease specificity .
more recently , some specific instruments have been developed to measure the qol in osteoporosis more accurately .
the most widely used are the osteoporosis quality of life questionnaire ( oqlq ) , the osteoporosis assessment questionnaire ( opaq ) , the osteoporosis - targeted quality of life questionnaire ( optqol ) , and the quality of life questionnaire of the european foundation for osteoporosis ( qualeffo-41 ) .
one of the first ones was qualeffo-41 , which has been translated and validated in different languages including italian .
this questionnaire has proved to be repeatable , coherent , and able to discriminate between patients and controls . in the last few years , other specific questionnaires
have been developed , but not all of them have been as extensively used and validated in different countries as qualeffo-41 .
the goal of this study was firstly to assess the validity of rhpth treatment in a cohort of postmenopausal women with severe osteoporosis ; secondly , to evaluate the improvement in qol and pain symptoms after several months of rhpth therapy .
a follow - up qualeffo-41 questionnaire was used to quantify the patient s pain and the affect on qol after rhpth therapy .
the study was a 18 months , randomized prospective cohort study conducted at department of molecular and clinical endocrinology and oncology , university of naples federico ii , naples , italy .
inclusion criteria for this study consisted of back pain , postmenopausal osteoporosis ( t - score 2.5 at lumbar spine or femoral neck ) , the presence of 2 osteoporotic vertebral fractures , previous treatment for osteoporosis .
the exclusion criteria were : an increased risk of osteosarcoma ( ie , patients with paget disease bone , previous skeletal exposure to external beam radiotherapy , or previous malignant neoplasm involving the skeleton ) , hypercalcemia , malignant neoplasms , impaired renal function , liver disease , history of diseases other than postmenopausal osteoporosis that affect bone metabolism , nephrolithiasis , alcohol or drug abuse .
secondary osteoporosis was excluded in order to avoid the interference of the primitive disease with the patient s quality of life .
informed consent was obtained from all subjects and the study protocol was approved by the hospital / science s ethical committee .
eighty - one postmenopausal women were enrolled and divided in two groups with no statistically significant differences in any of the considered variables : group a  forty - two women ( mean age 659 yrs ; mean body mass index 
bmi 24.52.6 kg / m ) , with severe postmenopausal osteoporosis ( mean lumbar bmd 3.880.70 , mean femoral neck bmd 3.070.60 and with 2 vertebral atraumatic fractures ) , persistent back pain and previous treatment with biphosphonates for osteoporosis ; group b  thirty - nine women matched for age ( 6014.4 yrs ) , bmi ( 22.88.8 kg / m ) , menopausal status , affected by back pain , severe postmenopausal osteoporosis ( lumbar spine bmd 3.900.73 , mean femoral neck bmd 3.020.61 and with 2 vertebral atraumatic fractures ) previously treated for osteoporosis with biphosphonates .
bmi , age at menopause , lifestyle habits ( i.e. , smoking , drinking , nutrition style ) , nutrition anamnesis ( calcium intake ) , history of diseases other than osteoporosis , family history of osteoporosis were considered .
groups were randomized to daily treatment with 20 g s.c . of recombinant human parathyroid hormone ( rhpth 134 ) , self - administered injections ( group a ) or 70 mg per os of alendronate every week ( group b ) .
all women received 1,000 mg elemental calcium daily and 800 iu of vitamin d daily for 18 months .
biochemical markers of bone turnover were dosed in all the selected female patients : alkaline phosphatase ( alp : 35104
u / l ) , n - terminal propeptide of type i procollagen ( pinp : 19102 g / l ) , n - telopeptide crosslinks ( ntx : 565 nmol / mmol crea ) were assessed at baseline , 3 , 12 and 18 months ( t0 , t3 , t12 , t18 ) .
the bmd of the lumbar spine and the proximal femur was measured by dual - energy x - ray absorptiometry ( dual - energy x - ray absorptiometry qdr 1000 ; hologic , waltham , ma , usa ) at baseline and at 18 months ( t0 , t18 ) .
all women underwent anteroposterior and lateral radiography of thoracic and lumbar spine at t0 and t18 .
the qol questionnaire of the european foundation for osteoporosis ( qualeffo ) was administered at baseline and at the end of the study to evaluate the impact of rhpth on health - related qol .
originally , the questionnaire consisted of 48 questions and 6 visual analogue scales . in the qualeffo validation study ,
this resulted in the qualeffo-41 , which consisted of 41 questions in 5 domains : pain , physical function , social function , general health perception , and mental function .
all answers were recorded so that all items range from 1 to 5 , and all answers were standardized so that 1 represents the best and 5 the worst qol , with the exception of questions e23 - 25 ( questions with 3 answer options ) , questions e24 - 26 - 27 - 28 ( 4 answer options ) , and questions g33 - 34 - 35 - 37 - 39 - 40 ( answer with reverse scores : 1 is the worst while 5 is the best ) .
domain scores are calculated by averaging the answers of 1 domain and transforming the scores to a score from 0 to 100 .
data are expressed as mean  sd or percentage ; moreover , to assess the affect of teriparatide treatment on markers of bone turnover , bone mineral density , and on health - related qol , pearson correlation coefficients were computed in the 2 study groups .
therefore , percentage changes of biomarkers , bone mineral density , and qualeffo results were calculated .
there was no significant difference in these characteristics between the 2 groups . in the group a , 39 ( 93% ) out of the 42 recruited women completed the study : 2 patients discontinued the drug therapy because of lack of compliance with the study treatment ; 1 patient discontinued because of a new vertebral atraumatic fracture .
the aim of this study was to evaluate percentage changes from baseline in biochemical markers of bone turnover , values of bone mineral density ( measured at lumbar spine and proximal femur ) , and measurements of qol .
follow - up checks , where we also evaluated clinical conditions , adverse events , compliance to treatment and use of non - steroid anti - inflammatory drugs , were carried out at 3 , 12 and 18 months since the beginning of treatment . in group a serum levels of pinp increased of 90% , 145% and 127% at t3 , t12 , t18 , respectively ; bone alp levels increased of 57% , 79% and 65% ; ntx levels increased of 53% at t3 , of 100% at t12 , of 110% at t18 . in group
b percentage changes from baseline of serum levels of pinp were 50% , 70% and 74% at t3 , t12 , t18 , respectively ; bone alp levels decreased of 30% , 48% and 41% ; ntx levels were reduced by 55% at t3 , of 69% at t12 , of 72% at t18 .
mean percentage changes from baseline are shown over time for all 3 biochemical markers in figures 1 and 2 .
mean pinp values were 426 g / l at t0 , 8012 g / l at t3 , 10334 g / l at t12 , 9526 g / l at t18 in group a ( t0 vs t3 r : 0.81 , p<0.001 ; t0 vs t12 r : 0.88 , p<0.001 ; t0 vs t18 r : 0.86 , p<0.001 ) and
7816 g / l , 395 g / l , 2313 g / l , 208 g / l at t0 , t3 , t12 , t18 respectively ( t0 vs t3 r : 0.67 , p<0.001 ; t0 vs t12 r : 0.76 , p<0.001 ; t0 vs t18 r : 0.82 , p<0.001 ) . in group
u / l , 10720 u / l at t3 , 12245 u / l at t12 and
11235 u / l at t18 ( t0 vs t3 r : 0.72 , p<0.001 ; t0 vs t12 r : 0.46 , p<0.01 ; t0 vs t18 r : 0.85 , p<0.001 ) ; instead , in group b mean alp was 72 15 u / l at baseline , 5015 after 3 months , 3717 u / l at t12 and 427 u / l at the end of the study ( t0 vs t3 r : 0.91 , p<0.001 ; t0 vs t12 r : 0.53 , p<0.001 ; t0 vs t18 r : 0.65 , p<0.001 ) .
ntx mean values in group a were 317 nmol / mmol crea , 4721 nmol / mmol crea , 6211 nmol / mmol crea , 6523 nmol / mmol crea at t0 , t3 , t12 and t18 respectively ( t0 vs t3 r : 0.22 , p>0.1 ; t0 vs t12 r : 0.57 , p<0.001 ; t0 vs t18 r : 0.49 , p<0.01 ) while in group b ntx mean values were 534 nmol / mmol crea at t0 , 29 11 nmol / mmol crea at t3 , 2013 nmol / mmol crea at t12 and 158 nmol / mmol crea at t18 ( t0 vs t3 r : 0.74 , p<0.001 ; t0 vs t12 r : 0.58 , p<0.001 ; t0 vs t18 r : 0.69 , p<0.001 ) . by the end of the study period ,
the bmd values expressed in terms of t - score in our total pool displayed important changes ( figure 3 ) . at month 18 ,
lumbar spine bmd increased by 12.4% in group a compared with group b in which it increased by 3.85% .
specifically , in group a mean t - score at t0 was 3.870.71 and mean t - score at t18 was 3.390.72 ( r : 0.88 ; p<0.001 ) ; instead , in group b , mean t - score at t0 was 3.900.73 and mean t - score at t18 : 3.750.72 ( r : 0.98 ; p<0.001 ) .
the bmd in the femur increased from baseline at month 18 , in group a , by 5.2% and by 1.99% in group b. in group a , mean femoral neck t - score was 3.070.60 at baseline and mean t - score at t18 was 2.910.63 at the end of the study ( r : 0.87 ; p<0.001 ) ; in group b , mean femoral t - score was 3.020.61 at t0 and 2.960.64 at t18 ( r : 0.99 ; p<0.001 ) . at t0 ,
patients treated with teriparatide were more protected against new fractures , compared with patients treated with bisphosphonates ; in fact , only 1 new vertebral fracture occurred in group a ( 2.4% ) at study endpoint ( t18 ) vs 6 new vertebral fractures that occurred in group b ( 15.7% ) at t18 .
the most - common reported adverse effects were back pain worsened in the first month of treatment that was reported by 14% of women ; nausea , reported by 10% ; headache and dizziness that were reported by only 1 and 2 women .
the reported adverse effects were abdominal pain in 9 patients , arthralgia in 4 patients , and dyspepsia in 1 patient .
we evaluated the teriparatide impact on several aspects of qol by administering the patients qualeffo-41 test at t0 and t18 ( figure 4 ) .
first domain ( domain a ) result indicated a serious reduction in pain ( 22% ) after treatment with rhpth : mean scores measured was 729.2 at start and 5614 after 18 months ( r : 0.61 ; p<.001 ) compared with group b ( 9.7% ; 718.7 at t0 and 6511 at t18 ; r : 0.53 ; p<.001 ) .
for everyday activities ( domain b ) , an average of 5513.6 was measured at t0 and of 4022.9 at t18
( r : 0.44 ; p<.01 ) in group a which had a total improvement of 27.3% , while the improvement was of 11% in group b ( 61.118 at t0 and 54.315.7 at t18 ; r : 0.68 ; p<.001 ) .
the performed domestic job domain ( domain c ) showed an improvement of 29% in group a ( 6010.7 at t0 ; 42.613.3 at t18 ; r : 0.68 ; p<.001 ) and of 2.9% in group b ( 62.113.3 at t0 ; 60.313.7 at t18 ; r : 0.88 ; p<.001 ) .
the mean score of domain d ( locomotor function ) was of 48.410 at baseline and 30.214.3 at the end of the study that indicates a percentage change of 37.8% in group a compared to group b where the change was of 11.5% ( 46.88.6 at t0 ; 41.410.05 at t18 ; r : 0.69 ; p<.001 ) .
the quality of free time and of the social activities ( domain e ) at the 2 time points they were 36.28.6 and 25.98.6 , indicating a percentage change of 28.4% in group a ( r : 0.50 ; p<.01 ) ; the values of group b were 38.214 at t0 and 34.214.3 at t18 reaching a percentage change of 10.5% only ( r : 0.87 ; p<.001 ) .
patients taking teriparatide showed also an improvement of 33.9% in the self - perception of their health ( domain f ) ( 5925 at t0 ; 3916.7 at t18 ; r : 0.84 ; p<.001 ) versus 12.8% improvement of group b ( 63.228.2 at t0 ; 55.124.8 at t18 ; r : 0.90 ; p<.001 ) . in the mood domain ( domain g ) ,
the qualeffo - test revealed a mean value of 20.67.2 at t0 and 29.39.7 at t18 in group a ( r : 0.71 ; p<.001 ) .
these data demonstrated a considerable improvement ( 29.7% ) compared with group b ( 1.8% ; 32.59.8 at t0 ; 33.19.9 at t18 ; r : 0.18 ; p>.1 ) .
as a consequence of pain relief , the consumption of nonsteroidal anti - inflammatory drugs also decreased in 29 women of group a , while it did not decrease in group b.
in group a serum levels of pinp increased of 90% , 145% and 127% at t3 , t12 , t18 , respectively ; bone alp levels increased of 57% , 79% and 65% ; ntx levels increased of 53% at t3 , of 100% at t12 , of 110% at t18 . in group
b percentage changes from baseline of serum levels of pinp were 50% , 70% and 74% at t3 , t12 , t18 , respectively ; bone alp levels decreased of 30% , 48% and 41% ; ntx levels were reduced by 55% at t3 , of 69% at t12 , of 72% at t18 .
mean percentage changes from baseline are shown over time for all 3 biochemical markers in figures 1 and 2 .
mean pinp values were 426 g / l at t0 , 8012 g / l at t3 , 10334 g / l at t12 , 9526 g / l at t18 in group a ( t0 vs t3 r : 0.81 , p<0.001 ; t0 vs t12 r : 0.88 , p<0.001 ; t0 vs t18 r : 0.86 , p<0.001 ) and
7816 g / l , 395 g / l , 2313 g / l , 208 g / l at t0 , t3 , t12 , t18 respectively ( t0 vs t3 r : 0.67 , p<0.001 ; t0 vs t12 r : 0.76 , p<0.001 ; t0 vs t18 r : 0.82 , p<0.001 ) .
u / l , 10720 u / l at t3 , 12245 u / l at t12 and
11235 u / l at t18 ( t0 vs t3 r : 0.72 , p<0.001 ; t0 vs t12 r : 0.46 , p<0.01 ; t0 vs t18 r : 0.85 , p<0.001 ) ; instead , in group b mean alp was 72 15 u / l at baseline , 5015 after 3 months , 3717 u / l at t12 and 427 u / l at the end of the study ( t0 vs t3 r : 0.91 , p<0.001 ; t0 vs t12 r : 0.53 , p<0.001 ; t0 vs t18 r : 0.65 , p<0.001 ) .
ntx mean values in group a were 317 nmol / mmol crea , 4721 nmol / mmol crea , 6211 nmol / mmol crea , 6523 nmol / mmol crea at t0 , t3 , t12 and t18 respectively ( t0 vs t3 r : 0.22 , p>0.1 ; t0 vs t12 r : 0.57 , p<0.001 ; t0 vs t18 r : 0.49 , p<0.01 ) while in group b ntx mean values were 534 nmol / mmol crea at t0 , 29 11 nmol / mmol crea at t3 , 2013 nmol / mmol crea at t12 and 158 nmol / mmol crea at t18 ( t0 vs t3 r : 0.74 , p<0.001 ; t0 vs t12 r : 0.58 , p<0.001 ; t0 vs t18 r : 0.69 , p<0.001 ) .
by the end of the study period , the bmd values expressed in terms of t - score in our total pool displayed important changes ( figure 3 ) . at month 18 ,
lumbar spine bmd increased by 12.4% in group a compared with group b in which it increased by 3.85% .
specifically , in group a mean t - score at t0 was 3.870.71 and mean t - score at t18 was 3.390.72 ( r : 0.88 ; p<0.001 ) ; instead , in group b , mean t - score at t0 was 3.900.73 and mean t - score at t18 : 3.750.72 ( r : 0.98 ; p<0.001 ) .
the bmd in the femur increased from baseline at month 18 , in group a , by 5.2% and by 1.99% in group b. in group a , mean femoral neck t - score was 3.070.60 at baseline and mean t - score at t18 was 2.910.63 at the end of the study ( r : 0.87 ; p<0.001 ) ; in group b , mean femoral t - score was 3.020.61 at t0 and 2.960.64 at t18 ( r : 0.99 ; p<0.001 ) .
at t0 , all patients of groups a and b showed baseline vertebral fractures . patients treated with teriparatide were more protected against new fractures , compared with patients treated with bisphosphonates ; in fact , only 1 new vertebral fracture occurred in group a ( 2.4% ) at study endpoint ( t18 ) vs 6 new vertebral fractures that occurred in group b ( 15.7% ) at t18 .
the most - common reported adverse effects were back pain worsened in the first month of treatment that was reported by 14% of women ; nausea , reported by 10% ; headache and dizziness that were reported by only 1 and 2 women .
the reported adverse effects were abdominal pain in 9 patients , arthralgia in 4 patients , and dyspepsia in 1 patient .
we evaluated the teriparatide impact on several aspects of qol by administering the patients qualeffo-41 test at t0 and t18 ( figure 4 ) . first domain ( domain
a ) result indicated a serious reduction in pain ( 22% ) after treatment with rhpth : mean scores measured was 729.2 at start and 5614 after 18 months ( r : 0.61 ; p<.001 ) compared with group b ( 9.7% ; 718.7 at t0 and 6511 at t18 ; r : 0.53 ; p<.001 ) . for everyday activities ( domain b ) , an average of 5513.6 was measured at t0 and of 4022.9 at t18 ( r : 0.44 ; p<.01 ) in group a which had a total improvement of 27.3% , while the improvement was of 11% in group b ( 61.118 at t0 and 54.315.7 at t18 ; r : 0.68 ; p<.001 ) .
the performed domestic job domain ( domain c ) showed an improvement of 29% in group a ( 6010.7 at t0 ; 42.613.3 at t18 ; r : 0.68 ; p<.001 ) and of 2.9% in group b ( 62.113.3 at t0 ; 60.313.7 at t18 ; r : 0.88 ; p<.001 ) .
the mean score of domain d ( locomotor function ) was of 48.410 at baseline and 30.214.3 at the end of the study that indicates a percentage change of 37.8% in group a compared to group b where the change was of 11.5% ( 46.88.6 at t0 ; 41.410.05 at t18 ; r : 0.69 ; p<.001 ) .
the quality of free time and of the social activities ( domain e ) at the 2 time points they were 36.28.6 and 25.98.6 , indicating a percentage change of 28.4% in group a ( r : 0.50 ; p<.01 ) ; the values of group b were 38.214 at t0 and 34.214.3 at t18 reaching a percentage change of 10.5% only ( r : 0.87 ; p<.001 ) .
patients taking teriparatide showed also an improvement of 33.9% in the self - perception of their health ( domain f ) ( 5925 at t0 ; 3916.7 at t18 ; r : 0.84 ; p<.001 ) versus 12.8% improvement of group b ( 63.228.2 at t0 ; 55.124.8 at t18 ; r : 0.90 ; p<.001 ) . in the mood domain ( domain g ) , the qualeffo - test revealed a mean value of 20.67.2 at t0 and 29.39.7 at t18 in group a ( r : 0.71 ; p<.001 ) .
these data demonstrated a considerable improvement ( 29.7% ) compared with group b ( 1.8% ; 32.59.8 at t0 ; 33.19.9 at t18 ; r : 0.18 ; p>.1 ) .
as a consequence of pain relief , the consumption of nonsteroidal anti - inflammatory drugs also decreased in 29 women of group a , while it did not decrease in group b.
our results demonstrate that daily injections of rhpth for 18 months are an efficacious and generally well - tolerated therapy in postmenopausal women with severe osteoporosis . more importantly , in our experience rhpth therapy results in decreased fractures and pain symptoms in patients with osteoporosis , and
teriparatide is a bone - forming agent and its effect is demonstrated by increases in biochemical markers of bone turnover over the study period : bone formation markers showed more rapid and higher increases than resorption ones , suggesting an early imbalance of bone turnover in favor of formation ; these data are in agreement with previous studies .
treatment with teriparatide resulted in a greater increase in bone mineral density ( bmd ) .
after 18 months of therapy with rhpth , bone mineral density in the lumbar spine and of the proximal femur increased by 12.4% and 5.2% ; these reported percentage increases are consistent with results of other studies . at month 18 in patients treated with bisphosphonates , instead , lumbar spine increased only by 3.85% and the bone mineral density in the femur increased by 1.99% .
the differences in the percentage increases between the 2 groups of patients can be explained with substantial differences between antiresorptive and anabolic therapeutic effects on bone mass and architecture as well as on bone mineral density .
moreover , rhpth increases trabecular connectivity , whereas the majority of bone mineral density increases observed with bisphosphonate treatment are a result of increased mineralization of existing bone matrix .
teriparatide has been referred to be an efficacious treatment against new fractures , making a significant change in the course of severe osteoporosis , which can lead rapidly not only to varying degrees of disability , the loss of self - sufficiency , and to institutionalization , but also to death [ 3436 ] . in this study , we have confirmed that patients with osteoporosis treated with teriparatide experience improvements in pain symptoms .
in addition , use of teriparatide caused a considerable decrease of pain , accompanied by a consequent reduction of the need for nonsteroidal anti - inflammatory drugs by the patients ; this was the main factor that assured an absolute compliance of the patients .
in severe osteoporosis vertebral fractures are an important cause of back pain owing to muscle weakness and altered posture , resulting in serious acute and chronic pain that contributes to further disabilities ; in fact , vertebral fractures are the top health condition accounting for length of hospitalization , and added significantly to the length of hospitalization in patients admitted for other medical problems . apart from the physical disabilities had by these patients
in fact , patients with vertebral fractures often experience impaired physical functions , limited activities of daily living , limited leisure and recreational activities , and significant emotional distress with loss of self - esteem and depression [ 3436 ] . in this study
, we have confirmed that patients with osteoporosis treated with teriparatide experience improvements in pain symptoms . to analyze all these variables and to measure the values of qol at baseline and at the end of the study , we used the qualeffo - test , developed by lips and associates in 1997 .
specifically , we used qualeffo-41 , that represents a qol questionnaire which is brief , easy to administer , and with adequate preliminary psychometric properties .
we preferred this test to the generic ones ( such as nhp , sip , sf-36 , eq - sd ) because of its specificity in the evaluation of qol in people affected by osteoporosis with vertebral deformities ; in fact , disadvantages of generic instruments are that they usually include irrelevant questions and that these questionnaires are less able to investigate those aspects that mostly influence qol of osteoporotic patients [ 2628 ] .
this makes the qualeffo-41 potentially useful during routine clinical practice and research for the treatment and the follow - up of postmenopausal women with severe osteoporosis . by using this test
, our study evidences that the use of rhpth influences all considered domains of qol ; in fact , pain , physical and social functions , mood significantly improved in nearly all patients treated with rhpth at the end of the study .
thus , the reduction of back pain observed from baseline of active treatment through posttreatment follow - up is consistent with the reduction of new vertebral painful fractures , that means improved qol for this kind of patients .
our data clearly demonstrate that rhpth is more effective than bisphosphonates in acting on back pain and all the domains of qol .
adverse events ( back pain , headache , nausea , dizziness ) in our patients receiving rhpth were mild and transient , with a percentage lower than in previous studies .
the adverse effects attributed to teriparatide did not stop the patients from continuing with the treatment .
our results demonstrate that rhpth increases bone mineral density considerably , reduces the occurrence of new fractures , and the need for analgesic therapy .
therefore , this study evidences that this anabolic agent represents a valid therapeutic option in severe postmenopausal osteoporosis ; moreover , patients after this treatment experience , improvements not only in pain relief , but also in certain aspects of emotional functioning , activities of daily living , and leisure activities , improve qol considerably .
 summarybackgroundwe studied the use of teriparatide in postmenopausal women with severe osteoporosis.material/methodstwo groups ( a and b ) of patients affected by severe osteoporosis ( t - score 2.5 at bone mineral density were analyzed and 2 vertebral fractures on radiograph).group a was treated for 18 months with 20 g / day of teriparatide . 
 group b was treated with bisphosphonates 70 mg / week . 
 every woman assumed 1 g of calcium and 800 iu of vitamin d3 daily . 
 we evaluated the effects of therapy after 18 months ( t18 ) from the beginning with bone turnover markers ( alkaline phosphatase , procollagen type 1 n - terminal propeptide , and n - telopeptide cross - links ) and dual - energy x - ray absorptiometry.resultsgroup a , at t18 procollagen type 1 n - terminal propeptide levels , increased 127% ; bone alkaline phosphatase levels increased to 65% ; n - telopeptide cross - links levels increased to 110%.group b , at t18 procollagen type 1 n - terminal propeptide levels , decreased to 74% ; bone alkaline phosphatase levels decreased to 41% ; n - telopeptide cross - links levels decreased to 72%.after 18 months , lumbar bone mineral density increased to 12.4% and femoral bone mineral density increased to 5.2% in group a. group b lumbar bone mineral density increased to 3.85% and femoral bone mineral density increased to 1.99% . 
 only a new vertebral fracture occurred in group a ( 2.4% ) , whereas 6 fractures occurred in group b ( 15.7%).the quality of life questionnaire of the european foundation for osteoporosis ( qualeffo ) revealed a significant improvement in daily living , performed domestic jobs , and locomotor function in groups a and b.conclusionsthe use of rhpth in patients with severe osteoporosis offers more protection against fractures and improves the qol more than bisphosphonates . 
Background
Material and Methods
Results
Markers of bone turnover
Bone mineral density
X-ray evaluation
Adverse events
Quality of life
Discussion
Conclusions