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1.
Prevention of Corticosteroid-Induced Osteoporosis with Alendronate in Sarcoid Patients 总被引:10,自引:0,他引:10
S. Gonnelli P. Rottoli C. Cepollaro C. Pondrelli V. Cappiello M. Vagliasindi C. Gennari 《Calcified tissue international》1997,61(5):382-385
Prolonged corticosteroid administration, as often required in the treatment of sarcoidosis, increases the risk of osteoporosis
and fracture. The aim of the present study was to evaluate the usefulness of alendronate, a third generation bisphosphonate,
in preventing corticosteroid-induced osteoporosis. Forty-three consecutive, previously untreated, sarcoid patients (17 men
and 26 premenopausal women) were included in the study: 13 needed no treatment and served as controls (Group 1) and 30 needed
glucocorticoids (prednisone) and were randomly selected to also receive either placebo (n = 15, Group 2) or alendronate 5
mg/day (n = 15, Group 3). Bone mineral density (BMD) at the ultradistal radius by dual photon absorptiometry (Osteograph 1000,
NIM, Verona, Italy) and biochemical markers of bone turnover were measured at baseline and after 6 and 12 months of glucocorticoid
therapy. No significant difference was found between Groups 2 and 3 in the mean cumulative dose of prednisone (4945 ± 1956
mg and 5110 ± 2013 mg, respectively). At the end of the study period, BMD increased by 0.8% in the alendronate-treated group;
in the placebo-treated group, BMD decreased by 4.5%. The difference between groups was significant (P < 0.01, ANOVA). A significant decrease in markers of bone formation was found in all patients treated with prednisone (Groups
2 and 3), independently of alendronate. Alendronate, however, counteracted the increase in markers of bone resorption induced
by glucocorticoid therapy. Our data suggest that alendronate is effective in preventing glucocorticoid-induced bone loss in
sarcoid patients. Further studies on alendronate use in steroid-induced osteoporosis are needed.
Received: 30 September 1996 / Accepted: 30 April 1997 相似文献
2.
Sairanen S Kärkkäinen M Tähtelä R Laitinen K Mäkelä P Lamberg-Allardt C Välimäki MJ 《Calcified tissue international》2000,67(2):122-127
To evaluate the long-term effect of calcitriol treatment on bone mineral density (BMD) of the femoral neck and lumbar spine
and the parameters of calcium and bone metabolism in elderly women, 55 healthy, postmenopausal women, all aged 66 years, were
enrolled in the study. Eighteen started a 4-year supplementation with 0.5 μg of calcitriol daily and 37 served as controls.
Calcium intake of all the subjects was adjusted to 800 mg daily. In 4 years femoral neck BMD increased by 3.0% in the calcitriol
group, but decreased by 1.6% in the control group (P= 0.009). The respective changes in lumbar spine BMD were +2.3% and +0.9% (P= 0.067). Two years' treatment with calcitriol increased the intestinal absorption of strontium by 57% (P < 0.001), doubled the urinary excretion of calcium (P < 0.001), and decreased the mean parathyroid hormone (PTH) level by 32% (P < 0.01). In the calcitriol group the marker of bone formation, serum osteocalcin, decreased by 27% (P < 0.01), and the marker of bone resorption, serum C-telopeptide of type I collagen (CTx), by 33% (P= 0.05) after 2 years. In two subjects the calcitriol dose had to be reduced because of hypercalciuria. We conclude that calcitriol
treatment increases bone mass at the femoral neck and lumbar spine, the increases being maintained for up to 4 years. The
gain in bone mass results from reduced bone turnover which is partly a consequence of the enhanced intestinal absorption of
calcium and suppressed serum PTH levels.
Received: 8 January 1999 / Accepted: 29 February 2000 相似文献
3.
Fogelman I Fordham JN Fraser WD Spector TD Christiansen C Morris SA Fox J 《Calcified tissue international》2008,83(2):85-92
Treatment of postmenopausal osteoporosis (PMO) is based primarily on antiresorptive agents, including hormone replacement therapy (HT). To evaluate whether anabolic therapy together with HT provides additional benefits in the treatment of PMO, we evaluated the effects of parathyroid hormone (PTH) 1-84 in postmenopausal women with low bone mineral density (BMD) who were receiving chronic (>/=6 months) HT. Subjects were randomized to receive 100 mug PTH(1-84) or placebo injections daily for 24 months (n = 90/group). The primary efficacy outcome was change from baseline in lumbar spine BMD. Secondary end points included changes in hip and distal radius BMD, bone turnover markers, and fracture incidence. The study was terminated early following recommendations regarding HT for PMO. At 18 months, the mean increase in lumbar spine BMD was 7.9% for PTH(1-84) subjects vs. 1.5% for those receiving HT alone; between-group differences were significant at 6 months and persisted throughout the study. Lumbar spine BMD increased in 94% of women receiving PTH(1-84) compared to 59% for HT alone. Femoral neck BMD and bone turnover markers were significantly higher in PTH(1-84)-treated subjects, but the changes in total hip and distal radius BMD were not significant. PTH(1-84) treatment was generally well-tolerated, with hypercalciuria, hypercalcemia, nausea, vomiting, and dizziness reported more frequently in the HT + PTH(1-84) group. In conclusion, addition of PTH(1-84) to stable HT produced marked increases in lumbar spine BMD and may represent an additional approach to the treatment of PMO women receiving HT. 相似文献
4.
E. Jódar M. Begoña López L. García D. Rigopoulou G. Martínez F. Hawkins 《Osteoporosis international》1998,8(4):311-316
The effects of suppressive doses of levothyroxine (LT4) on bone mass are controversial. Our aim was to evaluate the effects on axial and appendicular bone mineral density (BMD)
and bone metabolism of long-term LT4 suppressive therapy in women by means of cross-sectional and longitudinal studies, and also to assess the potential influence
of menopausal status and LT4 dose. Seventy-six women (aged 47 + 13 years, 37 pre- and 39 postmenopausal) on suppressive therapy (67 + 34 months duration,
mean LT4 dose 168 + 41 mg/day) from our Thyroid Cancer Unit without previous hyperthyroidism or concomitant hypoparathyroidism were
studied. Serum TSH, T3 free T4, calcium, phosphorus, alkaline phosphatase, BGP, iPTH and urinary calcium (uCA) were measured. BMD was measured by dual-energy
X-ray absorptiometry (DXA) at lumbar spine, femoral neck, Ward's triangle, ultradistal and distal third radius and expressed
as a Z-score. In a subset of 27 women aged 46 + 15 years (14 pre- and 13 postmenopausal) a second densitometry scan was performed
27 + 5 months later. Patients on suppressive therapy showed a small reduction in BMD at the distal third radius (Z-score: 70.77 + 0.98; 95% confidence interval: 71.11, 70.44) without differences between pre- and postmenopausal women. Significant
relations with the regimen of suppressive therapy and bone turnover markers were detected except at the lumbar spine. In the
longitudinal study a significant although mild reduction in femoral neck BMD was found that correlated with prior T3 and iPTH. In conclusion, our data show a small detrimental effect of cautious LT4 suppressive therapy on bone mass assessed by DXA; it remains to be established whether this increases the prevalence of fractures.
Received: 30 June 1997 / Accepted: 7 November 1997 相似文献
5.
Effects of Risedronate Treatment on Bone Density and Vertebral Fracture in Patients on Corticosteroid Therapy 总被引:22,自引:0,他引:22
Wallach S Cohen S Reid DM Hughes RA Hosking DJ Laan RF Doherty SM Maricic M Rosen C Brown J Barton I Chines AA 《Calcified tissue international》2000,67(4):277-285
Men and women (n = 518) receiving moderate-to-high doses of corticosteroids were enrolled in two studies with similar protocols
and randomly assigned to receive either placebo or risedronate (2.5 or 5 mg) for 1 year. All patients received daily calcium
supplementation (500–1000 mg), and most also received supplemental vitamin D (400 IU). The primary endpoint was the difference
between the placebo and active groups in lumbar spine bone mineral density (BMD) at 1 year; changes in BMD at other sites,
biochemical markers of bone turnover, and the incidence of vertebral fractures were also assessed. In the overall population,
the mean (SE) lumbar spine BMD increased 1.9 ± 0.38% from baseline in the risedronate 5 mg group (P < 0.001) and decreased 1.0 ± 0.4% in the placebo group (P= 0.005). BMD at the femoral neck, trochanter, and distal radius increased or was maintained with risedronate 5 mg treatment,
but decreased in the placebo group. Midshaft radius BMD did not change significantly in either treatment group. The difference
in BMD between the risedronate 5 mg and placebo groups was significant at all skeletal sites (P < 0.05) except the midshaft radius at 1 year. The 2.5 mg dose also had a positive effect on BMD, although of a lesser magnitude
than that seen with risedronate 5 mg. A significant reduction of 70% in vertebral fracture risk was observed in the risedronate
5 mg group compared with the placebo group (P= 0.01). Risedronate was efficacious in both men and women, irrespective of underlying disease and duration of corticosteroid
therapy, and had a favorable safety profile, with a similar incidence of upper gastrointestinal adverse events in the placebo
and active treatment groups. Daily treatment with risedronate 5 mg significantly increases BMD and decreases vertebral fracture
risk in patients receiving moderate-to-high doses of corticosteroid therapy.
Received: 11 October 1999 / Accepted: 1 May 2000 / Online publication: 27 July 2000 相似文献
6.
Osteoporosis and Apolipoprotein E Genotype in Older Adults: The Rancho Bernardo Study 总被引:1,自引:0,他引:1
D. G. von Mühlen E. Barrett-Connor D. L. Schneider P. A. Morin P. Parry 《Osteoporosis international》2001,12(4):332-335
Recent studies reported an association between apolipoprotein E (ApoE) 4 and osteoporosis. We examined the association of
ApoE 4 genotype with bone mineral density (BMD), bone loss and fracture risk in 596 men and 332 community-dwelling women aged
45–95 years. Women were postmenopausal and not using estrogen. At the baseline visit, BMD was measured at the ultradistal
and midshaft radius using single photon densitometry, and at the hip and lumbar spine using dual-energy X-ray absorptiometry.
Hip and lumbar spine BMD levels were remeasured 4 years later. Self-reported fractures were confirmed by radiology reports
in 95% of cases. ApoE allele distribution did not vary by age; 25% of men and 20% of women had one ApoE 4 allele. There were
no differences in BMD at the lumbar spine, total hip, ultradistal or midshaft radius in men or women with the ApoE 4 allele
compared with men or women without the ApoE 4 allele. After an average 4 year interval, there were also no differences in
the annualized percent change in BMD at the hip or lumbar spine in men or women with or without an ApoE 4 allele. One or more
clinical fractures were reported by 55 men and 109 women. Fewer, not more, clinical fractures were reported in men and women
with an ApoE 4 allele; these differences were not statistically significant (p= 0.21 and p= 0.62, respectively). These data do not support the hypotheses that there is an association between ApoE genotype and BMD,
bone loss or osteoporotic fractures in older community-dwelling men or women.
Received: 26 July 2000 / Accepted: 13 October 2000 相似文献
7.
Alendronate significantly increases bone mass and reduces hip and spine fractures in postmenopausal women. To determine whether
forearm densitometry could be used to monitor the efficacy of alendronate, we examined changes in bone mineral density (BMD)
at the forearm (one-third distal, mid-distal, ultradistal radius) versus changes at the hip (femoral neck, total hip) and
spine (posteroanterior and lateral) in a double-masked, randomized, placebo-controlled clinical trial of 120 elderly women
(mean age 70 ± 4 years) treated with alendronate for 2.5 years. We found that among women in the treatment group, BMD increased
by 4.0–12.2% at the hip and spine sites (all p<0.001), whereas BMD increased only nominally at the one-third distal radius (1.3%, p<0.001) and mid-radius (0.8%, p<0.05), and remained stable at the ultradistal radius. At baseline, forearm BMD correlated with that of the hip (r= 0.55–0.64, p<0.001), femoral neck (r= 0.54–0.61, p<0.001) and posteroanterior spine (r= 0.56–0.63, p<0.001). Changes in radial BMD after 1 year of therapy were not correlated with changes in hip and spine BMD after 2.5 years
of therapy. In contrast, short-term changes in total hip and spine BMD were generally positively associated with long-term
changes in total hip, femoral neck and spine BMD (r= 0.30–0.71, p<0.05). Furthermore, long-term BMD changes at the forearm did not correlate with long-term hip and spine BMD changes, in contrast
to the moderate correlations seen between spine and hip BMD at 2.5 years (r= 0.38–0.45, p<0.01). We conclude that neither short- nor long-term changes in forearm BMD predict long-term changes in overall BMD for
elderly women on alendronate therapy, suggesting that measurements of clinically relevant central sites (hip and spine) are
necessary to assess therapeutic efficacy.
Received: 18 February 1999 / Accepted: 20 May 1999 相似文献
8.
D. Borderie B. Cherruau M. Dougados O. G. Ekindjian C. Roux 《Calcified tissue international》1998,62(1):21-25
To evaluate bone biochemical markers as predictors of the efficacy of a hormone replacement therapy (HRT), we studied the
bone changes induced by the cessation and return of ovarian function in 28 patients treated for 6 months with a GnRH agonist.
This model reproduced the effects observed in postmenopausal women with high bone turnover treated with HRT. At the end of
the treatment, Z scores were 1.8 ± 0.3 for Crosslaps (CTx) and deoxypyridinoline (D-Pyr), and 1.1 ± 0.2 for bone alkaline
phosphatase (B-ALP) and osteocalcin (OC). This indicated an imbalance in bone remodeling with a high bone resorption. Bone
mineral density (BMD) fell by 4.2 ± 2.5%. The changes in BMD between the 6th and 12th months were 0.34 ± 2.24 and −1.73 ±
3.25% at the lumbar spine and the femoral neck, respectively. Biochemical markers except urinary calcium and hydroxyproline
measured at 6 months were positively correlated with the BMD changes at the lumbar spine. After the resumption of menstruation,
13 of 28 women displayed positive spine BMD changes between the 6th and 12th months; in this group, bone biochemical markers
measured at 6 months were significantly higher (P= 0.02). Stepwise regression analysis showed that the association of B-ALP and D-Pyr measured at 6 months explained 40% of
BMD variance and the association of B-ALP, PTH, and estradiol 56%. We conclude that measuring individual biochemical bone
markers can help to predict the bone effect of an increase in the circulating estradiol in women with ovarian deficiency.
Received: 16 January 1997 / Accepted: 17 June 1997 相似文献
9.
N. Yoshimura T. Hashimoto K. Sakata S. Morioka T. Kasamatsu C. Cooper 《Calcified tissue international》1999,65(3):198-202
The purpose of this study was to ascertain whether biochemical markers of bone turnover predict bone loss. The survey was
carried out in Taiji, Wakayama Prefecture, Japan. From a list of inhabitants aged 40–79 years, 400 participants (50 men and
50 women in each of four age groups) were selected randomly. Bone mineral density (BMD) was measured, and blood and urine
samples of all participants were examined to obtain values for eight biochemical markers: alkaline phosphatase (ALP), bone
Gla protein (BGP), type I procollagen (carboxyterminal peptide of type I procollagen; PICP), cross-linked carboxyterminal
telopeptide region of type I collagen (ICTP), and urinary excretion of calcium (Ca), phosphate (P), pyridinoline (Pyr), and
deoxypyridinoline (D-Pyr). Each marker was evaluated as a predictor of the rate of bone change in lumbar spine and femoral
neck BMD over a 3-year period. The value of Pyr was significantly related to the change of lumbar spine BMD in men (P= 0.009), and that of BGP was found to be significant in women (P= 0.045). By contrast, none of the bone markers significantly correlated with bone loss at the femoral neck. The coefficient
of determination at the lumbar spine was 5% and 7% at the femoral neck only. We conclude that biochemical markers of bone
turnover cannot predict bone loss rates in middle-aged or elderly Japanese men and women over a 3-year period with sufficient
accuracy for use in clinical decision making.
Received: 26 January 1998 / Accepted: 9 July 1998 相似文献
10.
P F Schneider M Fischer B Allolio D Felsenberg U Schr?der J Semler J R Ittner 《Journal of bone and mineral research》1999,14(8):1387-1393
In addition to the alendronate Osteoporosis Intervention Trial (FOSIT) core protocol 901-0A of 1908 enrolled patients, the use of peripheral quantitative computed tomography (pQCT) was explored for the assessment of response to therapy. Bone mineral and strength related parameters at two different sites at the distal radius were explored in a subset of the multicenter core study. One hundred and three patients were entered into the substudy and given either a daily dose of 10 mg of alendronate or placebo for 1 year. Measurements were done at months 0, 3, 6, and 12. Inclusion criteria were bone mineral density (BMD) measurements at the lumbar spine of -2 SD. The response to therapy was assessed by dual-energy X-ray absorptiometry in the lumbar spine and the hip, and by pQCT in the ultradistal and the shaft sites of the radius. In line with the FOSIT core study, alendronate increased BMD at the lumbar spine and the hip, and it decreased the serum biochemical markers of bone turnover. The substudy showed differences between the therapy and placebo group in trabecular bone density (8.4%, p = 0.095), in total density (6.8%, p = 0.009), and in the bone strength index (BSI) (15. 6 mm3, p = 0.037) at the ultradistal site due to treatment and no changes at the radius shaft. A significant correlation was observed between percentage changes from baseline in BMD of the lumbar spine, and in total density and bone strength at the ultradistal radius site in the treatment group, but not in the placebo group. Thus, the ultradistal radius site did respond to alendronate therapy. The increased bone density accompanied a significant gain in the BSI at the ultradistal site, a finding that might help explain the reduced wrist fractures in the alendronate Fracture Intervention Trial. 相似文献
11.
O. Sahota I. Fowler P. J. Blackwell N. Lawson S. A. Cawte P. San T. Masud D. J. Hosking 《Osteoporosis international》2000,11(11):959-966
A number of drugs are now available for the treatment of established osteoporosis and have been shown to significantly increase
bone mineral density (BMD). There are, however, few comparative treatment studies and, furthermore, adverse events remain
a problem with some of the newer agents, particularly in the elderly, in everyday clinical practice. We report a 12 month,
open labeled, randomized controlled, prospective treatment study in 140 postmenopausal women with established vertebral osteoporosis,
comparing the effect of continuous alendronate, cyclical alendronate and cyclical etidronate with calcitriol in terms of gain
in BMD, reduction in bone turnover markers and adverse event profile. The mean percentage increases in BMD at 12 months, at
the spine and hip respectively, were: continuous alendronate 5.7%, 2.6%; cyclical alendronate 4.1%, 1.6%; cyclical etidronate
4.9%, 2.0% (p<0.01) and calcitriol 2.0%, 0.4% (NS). In comparison with calcitriol, the mean changes in BMD at the spine and hip respectively
were greater in the other groups; continuous alendronate: 3.7% (95% CI 1.4 to 8.3), 2.2% (95% CI 0.7 to 4.0); cyclical alendronate:
2.1% (95% CI 1.2 to 6.4), 1.2% (95% CI −0.3 to 3.0); cyclical etidronate: 2.9% (95% CI 1.9 to 6.5), 1.6% (95% CI 0.9 to 3.1)).
The reduction in bone turnover markers was between 26% and 32% in the alendronate and etidronate groups (p<0.01), with a trend toward greater reduction in the continuous alendronate group. Eight patients discontinued the study:
6 in the continuous alendronate group, 1 in the cyclical alendronate group and 1 in the calcitriol group. Two patients in
the cyclical etidronate group were unable to tolerate the Cacit component, but continued on substituting Cacit with Calcichew.
In summary, 12 months of treatment with continuous alendronate, cyclical alendronate and cyclical etidronate are effective
in terms of the gain in BMD at the anteroposterior spine and total hip in a comparable treatment population. These treatments
are more effective than calcitriol and were generally well tolerated. Continuous alendronate showed a trend toward a larger
gain in BMD and greater suppression of bone turnover markers than the other treatment groups, but had a higher incidence of
adverse events, particularly within the older subgroup. Cyclical alendronate offers a lower adverse event profile and appears
to be effective in comparison with continuous treatment, and may possibly be an alternative in the elderly. However, further
studies are necessary, but more importantly with fracture end-points.
Received: 6 April 1999 / Accepted: 8 June 2000 相似文献
12.
The Efficacy and Tolerability of Alendronate in Postmenopausal Osteoporotic Chinese Women: A Randomized Placebo-Controlled Study 总被引:4,自引:0,他引:4
Osteoporosis is a growing health problem in Asian women and it is expected that half of the world's hip fractures will occur
in Asia in 50 years' time. As the use of hormonal replacement therapy (HRT) is extremely low in postmenopausal Asian women,
nonhormonal agents will be more acceptable for the treatment and prevention of osteoporosis. The efficacy, tolerability, and
acceptability of alendronate, an amino-bisphosphonate, for Asian women was evaluated in 70 osteoporotic southern Chinese women
in a prospective, randomized, double-blind study. The subjects were randomized to receive either alendronate 10 mg daily or
placebo, plus calcium supplementation 500 mg daily. The baseline L 1–4 and hip bone mineral density (BMD) were similar between
both groups. At the end of 1 year, there was an increase of 5.8% in the lumbar spine BMD and 3.4% at the total hip with alendronate
treatment when compared with baseline values (P < 0.001). Alendronate treatment for 1 year resulted in significant improvement in BMD at all sites measured when compared
with placebo. There was also marked reduction in serum alkaline phosphatase (ALP) and urinary n-telopeptide (NTx) in the alendronate
group when compared with the placebo group (ALP 25% versus 2%, NTx 75% versus 14%, both P < 0.005). The changes in ALP and NTx at 6 and 12 months correlated with the change in BMD at all sites measured at 1 year
(P all <0.05). Alendronate was well tolerated and accepted, although two cases of gastric ulcer were reported. We conclude that
alendronate is an effective and well-accepted agent for the treatment of osteoporosis in Asian women.
Received: 30 September 1999 / Accepted 6 April 2000 相似文献
13.
Kenjiro Sawada Ken-ichirou Morishige Yukihiro Nishio Jun Hayakawa Seiji Mabuchi Aki Isobe Seiji Ogata Masahiro Sakata Masahide Ohmichi Tadashi Kimura 《Journal of bone and mineral metabolism》2009,27(2):175-181
A forearm fracture (Colles’ fracture) is often the first sign of osteoporosis and may suggest underlying skeletal fragility.
Therefore, establishment of a more accurate and reliable method for the measurement of bone mineral density (BMD) at the distal
radius would be beneficial for patients who suffer from osteoporosis. The objective of this study was to evaluate the usefulness
of peripheral quantitative computed tomography (pQCT) to monitor the response to alendronate therapy at the distal radius
in early postmenopausal Japanese women. Thirty-two early postmenopausal women who were diagnosed with osteoporosis or osteopenia
were randomized to either alendronate or control treatment. We analyzed the BMD of the distal radius by pQCT, lumbar spine
by dual-energy X-ray absorptiometry (DXA) and the biochemical markers of bone turnover (deoxypyridinoline) at baseline, 3,
6 and 12 months. The control group showed a significant decrease from baseline in the trabecular BMD of the radius at 12 months
(3.5 ± 3.7%; p < 0.01), whereas the alendronate group showed a significant increase (4.3 ± 8.1%). The changes in the trabecular BMD of the
radius between the alendronate and control groups were statistically different at 6 and 12 months (p < 0.01). However, in the total BMD at the diaphysis of the radius, no significant differences were seen in the changes in
bone densities between the alendronate and control groups after 1 year of treatment. pQCT detected significant differences
in BMD of the radius in early postmenopausal women after 1 year of treatment with alendronate. Collectively, our preliminary
clinical trial showed that pQCT might be useful to monitor response to alendronate therapy, especially at the radius, and
it might explain why alendronate prevents Colles’ fracture. 相似文献
14.
N. B. Watts D. K. Jenkins J. M. Visor D. C. Casal P. Geusens 《Osteoporosis international》2001,12(4):279-288
Alendronate therapy in osteoporotic women decreases bone turnover and increases bone mineral density (BMD). Optimal patient
management should include verification that each patient is responding to therapy. Markers of bone turnover and BMD have both
been proposed for this purpose. We have investigated changes resulting from alendronate therapy with an enzyme immunoassay
for bone alkaline phosphatase (BAP) and compared it with total alkaline phosphatase (TAP) and BMD of the lumbar spine, hip,
and total body. Subjects were drawn from a multicenter randomized, placebo-controlled trial of alendronate in postmenopausal
women with osteoporosis. BAP and TAP levels were measured at baseline and following 3, 6 and 12 months of therapy with either
placebo (n= 180) or alendronate 10 mg/day (n= 134). All subjects also received 500 mg/day supplemental calcium. BMD was measured at baseline and following 3, 6, 12, 18,
24 and 36 months of therapy. To compare BAP, TAP and BMD at each site for identifying women that experienced a skeletal effect
of alendronate, we calculated least significant change (LSC) values from the long-term intraindividual variability in each
placebo-treated woman. Median levels of BAP decreased by 34%, 44% and 43% at 3, 6 and 12 months, respectively, in alendronate-treated
women (p<0.0001 compared with baseline and with placebo). These changes were significantly greater (p<0.0001) than changes observed for TAP. Following 6 months of alendronate therapy, 90% of the women had experienced a decrease
in BAP exceeding the LSC compared with only 71% for TAP. The greatest number of women similarly identified with BMD at any
site (i.e. a gain in BMD exceeding the LSC) was 81% for spinal BMD at 36 months. All other sites were less than 70% at 36
months. Short-term changes in BAP and TAP were modestly associated with subsequent changes in BMD at all sites (Spearman’s
rho −0.22 to −0.52, p<0.05). Compared with TAP and BMD, BAP testing rapidly and sensitively identified skeletal effects of alendronate thus enabling
appropriate drug monitoring of osteoporotic women. Though BAP and TAP changes were modestly predictive of BMD changes, the
value of the bone marker tests is their ability to detect rapidly a skeletal effect of therapy.
Received: 19 May 2000 / Accepted: 31 October 2000 相似文献
15.
Jacques P Brown Richard L Prince Chad Deal Robert R Recker Douglas P Kiel Luiz H de Gregorio Peyman Hadji Lorenz C Hofbauer Jose M Álvaro‐Gracia Huei Wang Matthew Austin Rachel B Wagman Richard Newmark Cesar Libanati Javier San Martin Henry G Bone 《Journal of bone and mineral research》2009,24(1):153-161
Denosumab is a fully human monoclonal antibody that inhibits bone resorption by neutralizing RANKL, a key mediator of osteoclast formation, function, and survival. This phase 3, multicenter, double‐blind study compared the efficacy and safety of denosumab with alendronate in postmenopausal women with low bone mass. One thousand one hundred eighty‐nine postmenopausal women with a T‐score ≤ ?2.0 at the lumbar spine or total hip were randomized 1:1 to receive subcutaneous denosumab injections (60 mg every 6 mo [Q6M]) plus oral placebo weekly (n = 594) or oral alendronate weekly (70 mg) plus subcutaneous placebo injections Q6M (n = 595). Changes in BMD were assessed at the total hip, femoral neck, trochanter, lumbar spine, and one‐third radius at 6 and 12 mo and in bone turnover markers at months 1, 3, 6, 9, and 12. Safety was evaluated by monitoring adverse events and laboratory values. At the total hip, denosumab significantly increased BMD compared with alendronate at month 12 (3.5% versus 2.6%; p < 0.0001). Furthermore, significantly greater increases in BMD were observed with denosumab treatment at all measured skeletal sites (12‐mo treatment difference: 0.6%, femoral neck; 1.0%, trochanter; 1.1%, lumbar spine; 0.6%, one‐third radius; p ≤ 0.0002 all sites). Denosumab treatment led to significantly greater reduction of bone turnover markers compared with alendronate therapy. Adverse events and laboratory values were similar for denosumab‐ and alendronate‐treated subjects. Denosumab showed significantly larger gains in BMD and greater reduction in bone turnover markers compared with alendronate. The overall safety profile was similar for both treatments. 相似文献
16.
Hiroshi Kaji Itoko Hisa Yoshifumi Inoue Junko Naito Toshitsugu Sugimoto Masato Kasuga 《Journal of bone and mineral metabolism》2009,27(1):76-82
Bisphosphonate is an effective drug to reduce fracture risk in osteoporotic patients; however, factors affecting the efficacy
of bisphosphonate treatment are not fully known, especially in Japanese patients. In the present study, we examined the relationships
between an increase in lumbar spine bone mineral density (BMD) by bisphosphonates and several pretreatment parameters, including
biochemical, bone/mineral, and body composition indices, in 85 postmenopausal osteoporotic patients treated with alendronate
or risedronate. BMD increase was measured by dual-energy X-ray absorptiometry at the lumbar spine before and 2 years after
treatment. BMD increase at the lumbar spine was observed as independent of age, height, weight, body mass index, and fat mass,
although lean body mass seemed slightly related. On the other hand, fasting plasma glucose (FPG) levels were significantly
and positively related to BMD increase at the lumbar spine. In multiple regression analysis, FPG levels were not significantly
related to BMD increase at the lumbar spine when lean body mass was considered. As for bone/mineral parameters, BMD increase
at the lumbar spine was not significantly related to serum levels of calcium, parathyroid hormone (PTH), and alkaline phosphatase
or urinary levels of deoxypiridinoline and calcium excretion. As for BMD parameters, Z-scores of BMD at any site and bone geometry parameters obtained by forearm peripheral quantitative computed tomography were
not significantly related to BMD increase at the lumbar spine. BMD increases at the lumbar spine were similar between groups
with or without vertebral fractures. In conclusion, BMD increase at the lumbar spine by bisphosphonate treatment was not related
to any pretreatment parameters, including body size, body composition, and bone/mineral metabolism in postmenopausal Japanese
women with primary osteoporosis, although FPG correlated partly to BMD through lean body mass. 相似文献
17.
The objective of this study was to evaluate whether the pharmacological activity of cyclical etidronate therapy is sustained
beyond the dosing period. A group of 121 postmenopausal women who had completed a 2-year, double-blind, placebo-controlled
parallel study with etidronate or placebo (400 mg/day for 14 days every 3 months) and calcium agreed to participate in a 1-year
open-label follow-up study to evaluate the effect of discontinuing etidronate treatment. Fifty-nine subjects in the former
etidronate group and 62 in the placebo group received 500 mg/day of elemental calcium; 54/59 and 58/62 subjects, respectively,
completed the study. Outcomes of the study were bone mineral density (BMD), measured by dual energy X-ray absorptiometry (DXA),
and biochemical markers of bone turnover (urinary deoxypyridinoline/creatinine and serum osteocalcin). To determine whether
there was a residual effect of previous therapy we compared mean percentage changes from baseline (year 0) to year 3 for both
spinal and femoral neck BMD and markers of bone turnover in the former cyclical etidronate and placebo groups. To evaluate
the carryover effect of treatment we compared the percent change from year 2 to year 3 for the same variables. Mean percentage
change (SEM) from year 2 to year 3 for spinal BMD in the former cyclical etidronate group was −2.87% (0.48%) versus −0.99%
(0.36%) in the placebo group (P= 0.0022). In the femoral neck, the BMD changes were −0.86% (0.42%) versus −1.01% (0.41%) (NS). Biochemical markers increased
within 6 months toward baseline levels. Mean percentage changes from baseline (year 0) in both spinal and femoral neck BMD
were significantly different between groups 1 year after treatment discontinuation. No differences between groups were maintained
in deoxypyridinoline and osteocalcin. It is concluded that following withdrawal of cyclical etidronate therapy bone loss resumes
at a normal and moderately accelerated rate in the proximal femur and lumbar spine, respectively. A positive effect on BMD
at both cortical and trabecular sites is maintained for 1 year after treatment withdrawal.
Received: 8 May 1999 / Accepted: 10 December 1999 相似文献
18.
Association Between Colles’ Fracture and Low Bone Mass: Age-Based Differences in Postmenopausal Women 总被引:3,自引:0,他引:3
E. Kanterewicz E. Kanterewicz A. Yañez A. Pérez-Pons I. Codony L. Del Rio A. Díez-Pérez 《Osteoporosis international》2002,13(10):824-828
Colles’ fracture (CF) in postmenopausal women has been linked to low bone mass at the lumbar spine and hip. However, the
diverse methodological approaches of previous studies make the results difficult to compare and thus the implications of CF
in osteoporosis daily clinical practice are not clear. We explored the association between CF and low bone mineral density
(BMD) in an incident case-control study in 58 postmenopausal Spanish women aged 45–80 years with recent CF and in 83 population-based
controls of the same age range. The BMD of ultradistal distal forearm, lumbar spine and hip was measured by dual-energy X-ray
absorptiometry (DXA) and WHO criteria were used to define osteoporosis and osteopenia. BMD was significantly lower in cases
for all three areas (p<0.001). Osteoporosis was more prevalent in cases than controls in the wrist (60% vs. 35%, p<0.001), lumbar spine (47% vs. 20%, p<0.005) and hip (19% vs. 6%, p<0.005). After adjusting for age, menopausal status and body mass index, osteoporosis and osteopenia remained significantly
associated with CF only in women aged 65 years or less (ultradistal forearm OR 5.7 (95% CI 1.2–27.2), lumbar spine OR 3.9
(95% CI 1.1–14.3)). We conclude that CF in postmenopausal women aged 65 or less may be used as a sentinel finding to identify
patients with generalized osteoporosis. Additionally, 70% of all CF patients regardless of their age had low bone mass (T-score<−1SD) in any studied site.
Received: 3 December 2001 / Accepted: 22 May 2002 相似文献
19.
We examined the effects of a total body resistive training program (RT) on total and regional bone mineral density (BMD)
in older women. Twenty-seven healthy postmenopausal women (mean age 62 ± 1 years) participated in a strength training program
three times/week for 16 weeks. Strength was assessed before and after training by either one or three repetition maximum (1RM
and 3RM) tests. Both upper and lower body strength significantly increased by 36–65% and 32–98%, respectively, after training.
There was a small but significant decrease in body weight and body mass index after training (P < 0.05), with no change in the waist-to-hip ratio. BMD, assessed by dual-energy X-ray absorptiometry, did not change over
the duration of the training period in the anterioposterior spine (L2–L4), femoral neck, Ward's triangle, and greater trochanter. BMD of the total body, lateral spine (B2–B4), and the regions of the radius (1/3 radius and ultradistal radius) also did not fall in subsets of these women. Muscular
strength of both the leg and chest press were significantly associated with L2–L4, femoral neck, Ward's triangle, and greater trochanter BMD (range r = 0.57–0.84, all P < 0.005). Markers of bone turnover, namely, bone-specific alkaline phosphatase, osteocalcin, and urinary aminoterminal cross-linked
telopeptide of type I collagen did not change significantly. In conclusion, a resistive training program maintains BMD and
improves muscular strength in healthy, older women. This may be important in preventing the negative health outcomes associated
with the age-related loss of bone density.
Received 5 June 1996 / Accepted: 26 June 1997 相似文献
20.
W. F. Lems M. C. Lodder P. Lips J. W. J. Bijlsma P. Geusens N. Schrameijer C. M. van de Ven B. A. C. Dijkmans 《Osteoporosis international》2006,17(5):716-723
Introduction Alendronate has been described to have a bone-sparing effect in patients treated with moderate and high dosages of prednisone
for heterogeneous diseases, however no data are available on groups of patients with the same underlying diseases who receive
chronic low-dose prednisone treatment. The objective of the investigation reported here was, therefore, to study the effect
of alendronate on bone mineral density (BMD) of the lumbar spine and hips in patients with rheumatoid arthritis (RA) who are
on chronic low-dose prednisone treatment.
Methods A total of 163 patients with RA, according to the ACR-criteria, were enrolled in a double-blind, placebo-controlled trial.
The patients were treated with low-dose prednisone (≤10 mg/day) for at least 3 months. The patients were randomized to receive
daily doses of alendronate or placebo: men and premenopausal women received 5 mg alendronate (or placebo) daily; postmenopausal
women received 10 mg alendronate (or placebo) daily. All patients received daily calcium (500 mg, or 1000 mg, depending on
baseline dietary calcium intake) and vitamin D3 (400 IU) supplementation. BMD of the lumbar spine (L1–L4) and the (total) hip was measured at baseline and after 6 and 12 months.
The primary endpoint was change in BMD of the lumbar spine after 12 months (ITT). At baseline and after 3 and 12 months, serum
bone-specific alkaline phosphatase (BAP) and urinary excretion of N-telopeptide (NTX) were measured. Radiographs of the thoracic and lumbar spine were made at baseline and after 12 months and
subsequently scored for vertebral deformities.
Results The groups were comparable at baseline in age, gender, daily dosage of prednisone, BMD at the spine and the hip and markers
of bone turnover, while the number of patients with prevalent vertebral deformities was slightly higher in the alendronate-treated
patients (54% versus 39%, not significant). After 12 months, BMD at the lumbar spine had increased by 3.7% in the alendronate-treated
patients and decreased by –1.0% in the placebo-treated patients (p<0.0001); at the hip, the changes were +1.0% and –0.1%, respectively (not significant). After 3 months, serum BAP had decreased
by 16.9% in the alendronate group versus 3.3% in the placebo group (p=0.0005), while urinary NTX had decreased by 46.4% in the alendronate group versus 12.1% in the placebo group (p<0.0001). After 12 months, no statistically significant difference was found between the groups with respect to number of
patients with incident vertebral or non-vertebral fractures. Adverse effects were relatively common in these patients with
severe RA: adverse effects were observed in 68% of the alendronate-treated patients and in 73% of the placebo patients (not
significant), while serious adverse events were observed in 13% and 17%, respectively (not significant).
Conclusion We observed a favourable effect of alendronate on the BMD of the lumbar spine and on the markers of bone turnover in patients
with RA treated with low-dose prednisone. These data support the conclusion that the prescribing of alendronate is not only
beneficial in patients treated with high-dose prednisone but also in RA patients chronically treated with low-dose prednisone.
This trial was financially supported by a grant from MSD, The Netherlands 相似文献