共查询到20条相似文献,搜索用时 15 毫秒
1.
R. P. Heaney T. M. Zizic I. Fogelman W. P. Olszynski P. Geusens C. Kasibhatla N. Alsayed G. Isaia M. W. Davie C. H. Chesnut III 《Osteoporosis international》2002,13(6):501-505
Risedronate treatment reduces the risk of vertebral fracture in women with existing vertebral fractures, but its efficacy
in prevention of the first vertebral fracture in women with osteoporosis but without vertebral fractures has not been determined.
We examined the risk of first vertebral fracture in postmenopausal women who were enrolled in four placebo-controlled clinical
trials of risedronate and who had low lumbar spine bone mineral density (BMD) (mean T-score =–3.3) and no vertebral fractures at baseline. Subjects received risedronate 5 mg (n= 328) or placebo (n= 312) daily for up to 3 years; all subjects were given calcium (1000 mg daily), as well as vitamin D supplementation (up
to 500 IU daily) if baseline serum 25-hydroxyvitamin D levels were low. The incidence of first vertebral fracture was 9.4%
in the women treated with placebo and 2.6% in those treated with risedronate 5 mg (risk reduction of 75%, 95% confidence interval
37% to 90%; P= 0.002). The number of patients who would need to be treated to prevent one new vertebral fracture is 15. When subjects were
stratified by age, similar significant reductions were observed in patients with a mean age of 64 years (risk reduction of
70%, 95% CI 8% to 90%; P= 0.030) and in those with a mean age of 76 years (risk reduction of 80%, 95% CI 7% to 96%; P= 0.024). Risedronate treatment therefore significantly reduces the risk of first vertebral fracture in postmenopausal women
with osteoporosis, with a similar magnitude of effect early and late after the menopause.
Received: 12 September 2001 / Accepted: 11 December 2001 相似文献
2.
E. S. Siris J. A. Simon I. P. Barton M. R. McClung A. Grauer 《Osteoporosis international》2008,19(5):681-686
Summary This posthoc analysis of four trials studied the efficacy of risedronate to reduce fragility fractures in postmenopausal women
with osteopenia (i.e., T-scores between −1 and −2.5). Risedronate reduced the fracture risk by 73% (p = 0.023) in this population of women with low femoral neck bone mass and no prevalent vertebral fractures.
Introduction Low bone mass represents an increasing health risk and burden. Half of fragility fractures occur in osteopenic women underscoring
the need for treatments reducing fracture risk. This analysis reports the effect of risedronate to reduce fragility fracture
risk in osteopenic women without prevalent vertebral fractures.
Methods Postmenopausal women with osteopenia, defined as femoral neck T-score between −1 and −2.5 by DXA and no prevalent vertebral
fractures, were identified from four controlled randomized trials (BMD Multinational, BMD North America, VERT Multinational
and VERT North America). The risk reduction for fragility fractures in patients receiving 5 mg risedronate daily for 1.5 to
3 years compared to placebo was assessed. An additional sensitivity analysis excluded patients who were osteopenic at the
femoral neck but had a BMD lower than −2.5 SD at the lumbar spine.
Results Six hundred and twenty postmenopausal women with osteopenia were included, receiving either placebo (n = 309) or risedronate 5 mg (n = 311). Risedronate reduced the risk of fragility fractures by 73% over 3 years versus placebo (p = 0.023); cumulative fragility fracture incidence was 6.9% in placebo-treated versus 2.2% in risedronate-treated patients.
The magnitude of the effect was similar in the sensitivity analysis subset.
Conclusion Risedronate significantly reduced the risk of fragility fractures in postmenopausal women with osteopenia (femoral neck T-score
between −1 and −2.5 SD) and no prevalent vertebral fractures. 相似文献
3.
Prevention of Bone Loss with Risedronate in Glucocorticoid-Treated Rheumatoid Arthritis Patients 总被引:2,自引:0,他引:2
R. Eastell J.-P. Devogelaer N. F. A. Peel A. A. Chines D. E. Bax N. Sacco-Gibson C. Nagant de Deuxchaisnes R. G. G. Russell 《Osteoporosis international》2000,11(4):331-337
The aim of the study was to assess risedronate’s effect on bone mineral density in postmenopausal women with rheumatoid arthritis
receiving glucocorticoids. We carried out a two center, 2 year, double-masked, placebo-controlled trial with a third year
of nontreatment follow-up. We studied 120 women requiring long-term glucocorticoid therapy at >2.5 mg/day prednisolone randomized
to treatment with daily placebo; daily 2.5 mg risedronate; or cyclical 15 mg risedronate (2 out of 12 weeks). At 97 weeks,
bone mineral density was maintained at the lumbar spine (+1.4%) and trochanter (+0.4%) in the daily 2.5 mg risedronate group,
while significant bone loss occurred in the placebo group (–1.6%, p= 0.03; and 4.0%, p<0.005, respectively). At the femoral neck, there was a nonsignificant bone loss in the daily 2.5 mg risedronate group (–1.0%)
while in the placebo group bone mass decreased significantly (–3.6%, p<0.001). The difference between placebo and daily 2.5 mg risedronate groups was significant at the lumbar spine (p= 0.009) and trochanter (p= 0.02) but did not reach statistical significance at the femoral neck. Although not significantly different from placebo
at the lumbar spine, the overall effect of the cyclical regimen was similar to that of the daily 2.5 mg risedronate regimen.
Treatment withdrawal led to bone loss in the risedronate groups that was significant at the lumbar spine. A similar number
of patients experienced adverse events (including upper gastrointestinal events) across treatment groups and risedronate was
generally well tolerated. Thus risedronate preserves bone mass in postmenopausal women with rheumatoid arthritis receiving
glucocorticoids while patients receiving a placebo have significant bone loss.
Received: 2 June 1999 / Accepted: 29 September 1999 相似文献
4.
M. Fukunaga K. Kushida H. Kishimoto M. Shiraki Y. Taketani H. Minaguchi T. Inoue R. Morita H. Morii K. Yamamoto Y. Ohashi H. Orimofor the Risedronate Phase III Research Group 《Osteoporosis international》2002,13(12):971-979
To demonstrate the clinical benefit of 2.5 mg daily risedronate in the treatment of involutional osteoporosis, the effect
of risedronate on bone mineral density (BMD) of the lumbar spine was compared with that of etidronate, selected as a representative
of the bisphosphonates currently marketed in Japan. In this multicenter, randomized, double-masked, active (etidronate) controlled
comparative study, a total of 235 Japanese patients with involutional osteoporosis were randomized to receive either treatment
with 2.5 mg/day of risedronate for 48 weeks or intermittent treatment with etidronate (4 cycles of 2 weeks of treatment with
200 mg/day followed by 10-week medication-free periods). All patients received 200 mg of calcium supplement daily in the form
of the calcium lactate. Bone mineral density of the lumbar spine (L2–L4 BMD) was determined at 12, 24, 36 and 48 weeks by
dual-energy X-ray absorptiometry. The primary endpoint was the percent change in L2–L4 BMD from baseline to the time of final
evaluation. Changes in biochemical markers of bone turnover and safety profiles were also compared. A significant increase
in L2–L4 BMD was observed at 12 weeks after initiation of therapy in both the risedronate (2.8%) and etidronate (1.8%) groups.
The increase in L2–L4 BMD at the time of final evaluation in the risedronate group (4.9%) was significantly greater (p = 0.002) than that in the etidronate group (3.1%). The changes in bone resorption markers (urinary total deoxypyridinoline
and N-terminal telopeptide of type I collagen) from baseline to 48 weeks were −37.6% and −41.3% for risedronate and −22.5%
and −26.6% for etidronate, respectively. New vertebral fractures or deterioration of existing fractures were observed in 2.8%
(3/106) of the patients in the etidronate group, while no such cases (0/101) were observed in the risedronate group. No significant
difference in the incidence of adverse events was found between two treatments. Daily oral risedronate (2.5 mg) exhibited
efficacy superior to that of intermittent cyclical etidronate (200 mg) in increasing L2–L4 BMD, and was well tolerated by
Japanese patients with involutional osteoporosis.
Received: 7 February 2002 / Accepted: 18 July 2002 相似文献
5.
J. Y. Reginster C. Christiansen C. Roux J. Fechtenbaum A. Rouillon K. P. Tou 《Osteoporosis international》2001,12(3):169-177
The objective of the study was to determine the efficacy and safety of tiludronate in the treatment of postmenopausal osteoporosis.
Two placebo-controlled, randomized, double-masked, multicenter, cyclical, intermittent, dose-ranging studies including 1805
women with low vertebral bone mineral density and prevalent vertebral fractures and 488 women with low bone mineral density
and no prevalent fracture were conducted. Patients were randomized to either tiludronate 50 mg/day, tiludronate 200 mg/day
or placebo, given orally for the first 7 days of each month. A supplement of 500 mg elemental calcium was provided daily from
day 8 to the end of the month. Both studies demonstrated no statistically or clinically relevant trends in the incidence of
adverse effects accross the three treatment groups. However, tiludronate administered at these two doses in a cyclic intermittent
regimen was not effective in reducing the incidence of vertebral fractures or increasing spinal bone mineral density. Thus,
tiludronate, administered at these doses in a cyclic intermittent regimen, cannot be considered an appropriate treatment of
postmenopausal osteoporosis, notwithstanding a high safety profile.
Received: 6 July 2000 / Accepted: 25 September 2000 相似文献
6.
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
7.
Previous studies have paid much attention to the impact on functional impairment or quality of life from vertebral fractures
secondary to osteoporosis, but little research has addressed the function of osteoporotic women without fractures. The purposes
of this study were: (1) to describe spinal performance and functional impairment in postmenopausal women with osteoporosis
and osteopenia without vertebral fracture, and (2) to investigate the relationship between them. Thirty postmenopausal women
diagnosed as having osteoporosis or osteopenia were recruited who fulfilled the following criteria: (1) menopause for at least
6 months; (2) no vertebral fracture; (3) no medication that would interfere with calcium intake. Measurements included assessment
of functional impairment and spinal performance including trunk extension/flexion isokinetic strength, spinal range of motion
(ROM) and movement velocity in three planes (sagittal, frontal and transverse). The results showed that spinal ROM and velocity
were significantly reduced in the osteoporosis group compared with the osteopenia group (p<0.05), but no significant difference in trunk strength was shown. Functional impairment level showed a slight difference
between the two groups (p= 0.042). There was a significant correlation between spinal ROM and motion velocity with bone mineral density; however, functional
impairment correlated with motion velocity only in the transverse plane (trunk rotation) (p<0.05). Spinal strength did not show any correlation with other parameters. It was concluded that spinal motion performance
declined and functional impairment increased in relation to the severity of bone mineral loss in postmenopausal women without
vertebral fracture, but their physical performance was not correlated with functional impairments.
Received: 13 March 2001 / Accepted: 23 November 2001 相似文献
8.
Risedronate Rapidly Reduces the Risk for Nonvertebral Fractures in Women with Postmenopausal Osteoporosis 总被引:14,自引:0,他引:14
Harrington JT Ste-Marie LG Brandi ML Civitelli R Fardellone P Grauer A Barton I Boonen S 《Calcified tissue international》2004,74(2):129-135
Prevention of nonvertebral fractures, which account for a substantial proportion of osteoporotic fractures, is an important goal of osteoporosis treatment. Risedronate, a pyridinyl bisphosphonate, significantly reduces clinical vertebral fracture incidence within 6 months. To determine the effect of risedronate on osteoporosis-related nonvertebral fractures, data from four large, randomized, double-blind, placebo-controlled, Phase III studies were pooled and analyzed. The population analyzed consisted of postmenopausal women, with and without vertebral fractures, who had low bone mineral density (lumbar spine T-score <–2.5). Patients received placebo (N = 608) or risedronate 5 mg daily (N = 564) for 1 to 3 years. At baseline, 58% had at least one prevalent vertebral fracture, and the mean lumbar spine T-score was –3.4. Among placebo-treated patients, the presence of prevalent vertebral fractures did not increase the risk of incident nonvertebral fractures overall, although fractures of the humerus and hip and pelvis were more common in patients who had prevalent vertebral fractures than in those who did not. Risedronate 5 mg significantly reduced the incidence of nonvertebral fractures within 6 months compared with control. After 1 year, nonvertebral fracture incidence was reduced by 74% compared with control (P = 0.001), and after 3 years, the incidence was reduced by 59% (P = 0.002). The results indicate that risedronate significantly reduces the incidence of osteoporosis-related nonvertebral fractures within 6 months. 相似文献
9.
Treatment of Postmenopausal Women with Osteoporosis or Low Bone Density with Raloxifene 总被引:3,自引:0,他引:3
P. J. Meunier E. Vignot P. Garnero E. Confavreux E. Paris S. Liu-Leage S. Sarkar T. Liu M. Wong M. W. Draper 《Osteoporosis international》1999,10(4):330-336
Raloxifene, a selective estrogen receptor modulator (SERM), has been shown to improved bone mineral density (BMD) and serum
lipid profiles in healthy postmenopausal women. The objective of this study was to examine the effects of raloxifene on BMD,
biochemical markers of bone metabolism and serum lipids in postmenopausal women with low bone density or osteoporosis. This
Phase II, multicenter, 24-month, double-masked study assessed the efficacy and safety of raloxifene in 129 postmenopausal
women (mean age ± SD: 60.2 ± 6.7 years) with osteoporosis or low bone density (baseline mean lumbar spine BMD T-score: −2.8). Women were randomly assigned to one of three treatment groups: placebo, 60 mg/day raloxifene-HCl (RLX 60) or
150 mg/day raloxifene-HCl (RLX 150) and concomitantly received 1000 mg/day calcium and 300 U/day vitamin D3. At 24 months, BMD was significantly increased in the lumbar spine (+3.2%), femoral neck (+2.1%), trochanter (+2.7%) and
total hip (+1.6%) in the RLX 60 group compared with the placebo group (p<0.05). The RLX 150 group had increases in BMD similar to those observed with RLX 60. A greater percentage of raloxifene-treated
patients, compared with those receiving placebo, had increased BMD (p<0.05). Serum bone-specific alkaline phosphatase activity, serum osteocalcin, and urinary type I collagen:creatinine ratio
were significantly decreased in the RLX-treated groups, compared with the placebo group (p<0.01). RLX 60 treatment significantly decreased serum levels of triglycerides, and total- and LDL-cholesterol levels (p<0.01). The rates of patient discontinuation and adverse events were not significantly different among groups. In this study,
raloxifene increased bone density, decreased bone turnover, and improved the serum lipid profile with minimal adverse events,
and may be a safe and effective treatment for postmenopausal women with osteoporosis or low bone density.
Received: 26 December 1998 / Accepted: 31 March 1999 相似文献
10.
Effects of 8 Years of Treatment with Tibolone 2.5 mg Daily on Postmenopausal Bone Loss 总被引:2,自引:0,他引:2
The objective of this study was to assess the long-term effects of tibolone 2.5 mg daily (Livial1; Organon) on bone mineral density in recently postmenopausal women. An 8-year, open, nonrandomized, prospective study was
designed to compare the effects of tibolone 2.5 mg daily (n= 59) with an untreated control group (n= 51). The subjects of this study were 110 recently postmenopausal women (6–36 months since last menstrual period). The main
outcome measures were bone mineral density of the spine and femur, measured by dual-energy X-ray absorptiometry, and assessment
of biochemical markers of bone metabolism. After 8 years of tibolone use, the mean (± SEM) increase in bone mineral density
compared with baseline was 4.1%± 0.8% (p<0.0001) in the spine and 4.6%± 1.8% (p= 0.015) in the femoral neck. Over the same period, bone mineral density in the control group decreased in the spine by –7.5%±
1.1%, (p<0.0001) and in the femur by –6.7%± 1.2% (p<0.0001). The bone resorption marker, calcium/creatinine ratio, decreased in the tibolone group but not in the control group.
Serum bone formation markers decreased (alkaline phosphatase) or stayed approximately the same (osteocalcin) in the tibolone
group. Adherence was high, with 58% (34 of 59) of the tibolone group continuing treatment for 8 years. We conclude that tibolone
2.5 mg daily prevents bone loss in the lumbar spine and femoral neck over 8 years and adherence to treatment is high. The
greater bone density compared with untreated women would be expected to reduce the risk of bone fractures.
Received: September 2000 / Accepted: December 2000 相似文献
11.
Risedronate (Actonel 35 mg), which was promoted in Croatia a few months ago, is the latest (III) generation of bisphosphonates, the most efficient anti-resorption drugs that inhibit osteoclast-mediated bone resorption and change the bone metabolism. The effect of risedronate is 10 times stronger than that of alendronate, and 10.000 times stronger than that of etidronate. The bone turnover is reduced while the osteoblast activity and bone mineralisation are preserved. Decreases in biochemical markers of bone turnover were observed as soon as within 1 month and reached a maximum in 3-6 months of Actonel 35 mg application once a week or 5 mg a day. Several major international, randomised and placebo controlled clinical studies (VERT-NA, VERT-MN, HIP...) on more than 15,000 patients over 3-5 years of therapy have confirmed the speed, efficacy and excellent tolerability of risedronate in treating postmenopausal and corticosteroid-induced osteoporosis. After only 6 months of treatment VERT-NA and VERT-MN have shown a significant reduction in vertebral fracture risk versus control group, radiographically by 62% and clinically by 69% in the first year, which remains significant even after 5 years of treatment (50%) of postmenopausal osteoporosis. All the best properties of bisphosphonates have also been confirmed through a significant reduction in the relative risk of femoral neck fracture over 3 years of treatment by 40%, or by as much as 60% in female patients with osteoporosis and prevalent vertebral fracture, compared with controls. With risedronate we can achieve a quick and significant reduction in vertebral fracture risk in postmenopausal women (65%), especially among a high-risk population such as patients on long-term glucocorticoid therapy (70%) in the very first year of treatment. Prevention and treatment of glucocorticoid-induced osteoporosis is recommended in the administration of 27,5 mg of prednisone or prednisone equivalent in a duration longer than 3 months, irrespective of age or gender. Tolerability and safety of risedronate administration in osteoporosis is very good, almost the same as in the control group, although patients with earlier described or ongoing gastrointestinal troubles were also included. The incidence of endoscopically confirmed gastric ulcer in treatment with alendronate is significantly higher (13,2%) versus controls than in treatment with risedronate (4,1%). Risedronate is hence the first line of bisphosphonates for the reduction of vertebral and non-vertebral fracture risks in postmenopausal women with osteoporosis or those with a high risk of osteoporosis. It also efficiently prevents bone loss or improves bone density in men and women on a long-term corticosteroid therapy. 相似文献
12.
D M Reid R A Hughes R F Laan N A Sacco-Gibson D H Wenderoth S Adami R A Eusebio J P Devogelaer 《Journal of bone and mineral research》2000,15(6):1006-1013
Long-term use of high-dose corticosteroids often results in bone loss, which may lead to osteoporosis-related fractures. This was a multicenter, double-blind study in which 290 ambulatory men and women receiving high-dose oral corticosteroid therapy (prednisone > or = 7.5 mg/day or equivalent) for 6 or more months were randomized to receive placebo, risedronate 2.5 mg/day, or risedronate 5 mg/day for 12 months. All patients received calcium 1 g and vitamin D 400 IU daily. The primary endpoint was lumbar spine bone mineral density (BMD) at month 12. Additional measurements included BMD at the femoral neck and trochanter and the incidence of vertebral fractures. Overall, there were statistically significant treatment effects on BMD at 12 months at the lumbar spine (p < 0.001), femoral neck (p = 0.004), and trochanter (p = 0.010). Risedronate 5 mg increased BMD at 12 months by a mean (SEM) of 2.9% (0.49%) at the lumbar spine, 1.8% (0.46%) at the femoral neck, and 2.4% (0.54%) at the trochanter, whereas BMD was maintained only in the control group. Although not powered to show fracture efficacy, we observed a reduction in the incidence of vertebral fractures of 70% in the combined risedronate treatment groups, relative to placebo (p = 0.042). Risedronate was well tolerated, had a good safety profile, and was not associated with gastrointestinal adverse events. We conclude that risedronate increases BMD and potentially reduces the incidence of vertebral fractures in patients with corticosteroid-induced osteoporosis. 相似文献
13.
Osteoporosis has become an important health problem in postmenopausal Asian populations as the prevalence of hip and vertebral fractures in some Asian countries has risen to approach that of Caucasian populations. Risedronate, a pyridinyl-bisphosphonate agent, is a potent inhibitor of bone resorption. Risedronate increases bone mineral density (BMD), reduces markers of bone turnover, and reduces the risk of fractures in Caucasian postmenopausal women. To determine the efficacy and tolerability of risedronate in Chinese, a multicenter, randomized, double blind, placebo controlled study was performed in Hong Kong. Sixty-five (65) postmenopausal osteoporotic Southern Chinese women, aged 67+/-6 years, were randomly assigned to receive either risedronate 5 mg daily (n=31) or placebo (n=34) for 12 months. All women received calcium carbonate 500 mg daily and vitamin D 400 IU daily. Mean baseline BMD T-score at the spine and total hip was -3.4 and -2.6, respectively. A significant increase in spine BMD was already evident at month 3 of risedronate treatment (P<0.001). Risedronate significantly increased BMD and reduced bone turnover markers as compared with placebo. The risedronate group had significant increase in BMD at 12 months at both the spine and hip when compared with the placebo group (L1-4 6.6% vs. 0.4%, P<0.001; total hip 2.7% vs. 0.3, P<0.0001; femoral neck 1.8% vs. 1.1%, P<0.02; trochanter 4% vs. 1.1%, P<0.0001, respectively). Significant changes in urine N-telopeptide (NTx) and serum osteocalcin were evident as early as 1 and 3 months, respectively, with risedronate treatment. No significant changes were seen in both BMD and bone markers in the placebo group. Risedronate was well tolerated without major adverse effects. We conclude that risedronate is an effective and well-tolerated agent for the treatment of postmenopausal osteoporosis in Asian population. 相似文献
14.
The aim of this study was to assess a dry calcaneal quantitative ultrasound (QUS) device by examining: (i) short- and long-term
precision; (ii) the ability of the ultrasound parameters to identify women with vertebral fractures; (iii) age- and menopause-related
bone loss; (iv) applicability of the WHO criteria in scan interpretation. The study group consisted of 422 healthy women with
no risk factors associated with osteoporosis (227 premenopausal and 195 postmenopausal) and 93 women with one or more vertebral
fractures. All women had calcaneal QUS and bone mineral density (BMD) measurements of the lumbar spine and hip performed.
Broadband ultrasound attenuation (BUA) and speed of sound (SOS) measurements in the heel were combined and expressed as estimated
heel BMD. Short-term precision studies yielded coefficient of variations of 0.3% for SOS, 4% for BUA and 3.3% for estimated
heel BMD. Standardized short-term precision values were approximately 0.2 SD. Long-term standardized precision errors ranged
from 0.17 to 0.38 SD. All the QUS and BMD measurement parameters showed significant negative relationships with age in the
postmenopausal group. Annual losses were 0.35 dB/MHz per year for BUA, 0.56 m/s per year for SOS and 0.002 g/cm2 per year for estimated heel BMD. All the QUS and BMD parameters were able to discriminate between healthy postmenopausal
women and women with vertebral fracture. Age-adjusted odds ratios for each SD decline in QUS measurements were 3.63, 5.25
and 4.79 for BUA, SOS and estimated heel BMD respectively. Corresponding odds ratios for BMD at the lumbar spine, femoral
neck and total hip were 2.39, 2.51 and 2.95 respectively. When the QUS and BMD parameters were expressed as T-scores, estimated heel BMD showed the least age-related decline, while femoral neck BMD displayed the greatest decrease with
age. The mean T-score and prevalence of osteoporosis (T<−2.5) for a Caucasian woman aged 60–65 years were −1.35 and 21% respectively for the lumbar spine compared with −0.59 and
2% for estimated heel BMD. In conclusion, this study revealed that contact ultrasound can detect age- and menopause-related
influences on bone status and was able to discriminate between healthy individuals and women with vertebral fracture. However,
the widely accepted threshold of a T-score of less than −2.5 for the definition of osteoporosis may need modifying for the interpretation of QUS scans.
Received: 8 February 1999 / Accepted: 5 May 1999 相似文献
15.
Effects of Raloxifene on Fracture Severity in Postmenopausal Women with Osteoporosis: Results from the MORE Study 总被引:3,自引:3,他引:0
E. Siris J. D. Adachi Y. Lu T. Fuerst G. G. Crans M. Wong K. D. Harper H. K. Genant 《Osteoporosis international》2002,13(11):907-913
Raloxifene reduces the risk of new vertebral fractures, but its effect on the severity of these new fractures has not been
determined. The MORE (Multiple Outcomes of Raloxifene Evaluation) trial studied the effects of placebo, raloxifene 60 or 120
mg/day in 7705 postmenopausal women with osteoporosis. Radiologists assessed new vertebral fractures from radiographs and
graded the fracture severity as normal (no fracture) or mild, moderate or severe. New clinical vertebral fractures were defined
as new vertebral fractures associated with symptoms, such as back pain, and confirmed in radiographs. In the total study population,
the majority (76.4%) of the women who experienced clinical vertebral fractures were diagnosed with new moderate/severe vertebral
fractures. In turn, women with moderate/severe vertebral fractures in the overall population were more likely to experience
clinical symptoms suggestive of fracture than were women who had new mild-only vertebral fractures. The incidence of new mild-only
and moderate/severe fractures was the same in women without prevalent vertebral fractures, but the incidence of new moderate/severe
fractures was 2 to 3 times higher than that for new mild-only fractures in women with prevalent vertebral fractures. Raloxifene
60 mg/day decreased the risk of at least 1 new moderate/severe vertebral fracture by 61% in women without prevalent vertebral
fractures [RR 0.39 (95% CI 0.17, 0.69)], and by 37% in women with prevalent vertebral fractures [RR 0.63 (95% CI 0.49, 0.83)]
at 3 years. The risk reductions for at least 1 new moderate/severe vertebral fracture were not significantly different between
the raloxifene doses, in women with and without prevalent vertebral fractures. The effects of raloxifene on significantly
decreasing the risk of new moderate/severe vertebral fractures may explain the risk reduction for new painful clinical vertebral
fractures observed with raloxifene, and is particularly important in postmenopausal women with severe osteoporosis who are
at higher risk for moderate or severe fractures.
Received: 11 April 2002 / Accepted: 19 June 2002
Correspondence and offprint requests to: Ethel Siris, MD, Toni Stabile Osteoporosis Center, Department of Medicine, College of Physicians and Surgeons, Columbia University,
180 Fort Washington Ave, New York, NY 10032, USA. Tel: +1 (212) 305 2529. Fax: +1 (212) 305 6482. e-mail: es27@columbia.edu 相似文献
16.
Do Men and Women Fracture Bones at Similar Bone Densities? 总被引:1,自引:0,他引:1
When the World Health Organization (WHO) guidelines for the definition of osteoporosis in postmenopausal women were identified
similar proposals were not developed for men as there was insufficient evidence about the relationship between bone density
and fracture in men. We have therefore examined the relationship between bone density and vertebral fracture in men and women
attending for assessment of possible osteoporosis. Two hundred and sixty-four women (age 64 [SD 10] years) and 37 men (age
55 [10] years) were studied. Bone density was measured in the lumbar spine and femoral neck by dual-energy X-ray absorptiometry
and expressed both as bone mineral density (BMD; g/cm2) and as T-scores. In both sexes there was a sigmoid relationship between the cumulative frequency of vertebral fracture and bone density
at both sites. There was a linear relationship between the log odds of fracture and bone mass for both sexes and both sites
(r= 0.97–0.99; p<0.0001). The slope of these lines was significantly steeper for men than women. The BMD at which there was 50% risk of fracture
was higher in men than women (0.908 vs 0.844 g/cm2). The difference between the slopes was similar when the bone mass was expressed as a T-score. However, the T-score associated with 50% prevalence of fracture was similar in the two sexes (F: −2.77 vs M: −2.60). We conclude that although
there is a different relationship between bone density and fracture in the two sexes the current WHO definition of osteoporosis
in postmenopausal women can be appropriately applied to men.
Received: 24 February 1999 / Accepted: 12 July 1999 相似文献
17.
F. Scopacasa M. Horowitz A. G. Need H. A. Morris B. E. C. Nordin 《Osteoporosis international》1999,9(6):494-498
Norethisterone 2.5 mg/day was administered to 26 postmenopausal women (aged 54–79 years) with varying degrees of osteoporosis
and with a forearm bone mineral density value more than 2 SD below the young normal mean. Fasting blood and urine samples
were collected and radiocalcium absorption measured at baseline and after treatment for a median period of 4 months. There
were significant falls in serum calcium and its fractions, phosphate, alkaline phosphatase and cholesterol (HDL and LDL),
and significant rises in serum chloride and parathyroid hormone. In the urine, there were significant falls in calcium, sodium
and hydroxyproline. These changes were in close agreement with our previously reported responses to norethisterone 5 mg/day.
We conclude that norethisterone in a dose of 2.5 mg/day is probably as effective as 5 mg/day in reducing bone resorption in
postmenopausal women with low bone density.
Received: 8 June 1998 / Accepted: 23 September 1998 相似文献
18.
Effects of Alendronate on Bone Density in Men with Primary and Secondary Osteoporosis 总被引:5,自引:0,他引:5
Alendronate has been reported to increase bone mineral density (BMD) and reduce fracture risk in women with osteoporosis.
As there are no proven safe and effective treatments available for men with osteoporosis, we compared the effects of alendronate
(10 mg/day) on BMD, measured using dual-energy X-ray absorptiometry, in a 12-month prospective, controlled, open label study
involving (i) men with primary (n= 23) or secondary osteoporosis (n= 18), (ii) postmenopausal women with primary (n= 18) or secondary (n= 21) osteoporosis, and (iii) 29 male and 14 female untreated controls matched by age, height and weight. The patients had
one or more vertebral fractures and ranged in age from 34.6 to 85.1 years. BMD was detectably increased relative to baseline
by 6 months, and increased by comparable amounts in males and females with primary or secondary osteoporosis. At 12 months,
lumbar spine BMD was 5.4%± 1.1% to 7.0%± 2.2% higher in the treated groups compared with baseline and controls (p<0.05 to 0.0001). Trochanteric BMD increased by 2.6%± 1.5% and 3.7%± 1.7% in treated men with primary and secondary osteoporosis,
respectively (p = 0.06 to 0.08), and by 3.9%± 1.3% in treated women with primary osteoporosis (p<0.01) after 12 months. No significant changes were detected at the femoral neck or Ward’s triangle. BMD remained unchanged
in controls. We infer that alendronate has comparable incremental effects on BMD in men and women with primary and secondary
osteoporosis within 12 months of treatment. The changes are in the order of 0.5 SD – effects associated with a clinically
worthwhile reduction in fracture risk. The data provide room for optimism regarding the role of alendronate in the treatment
of osteoporosis in men. Randomized, double-masked and placebo-controlled trials are needed to confirm these preliminary findings
and demonstrate antifracture efficacy using vertebral and nonvertebral fracture rates as the primary endpoint.
Received: 23 February 1999 / Accepted: 2 June 1999 相似文献
19.
Mellström DD Sörensen OH Goemaere S Roux C Johnson TD Chines AA 《Calcified tissue international》2004,75(6):462-468
The effects of 7 years of risedronate treatment were evaluated in a second 2-year extension of a 3-year vertebral fracture study in women with osteoporosis. For the first 5 years of the study, women received risedronate 5 mg/day or placebo according to the original randomization, with maintenance of blinding. All the women who entered into the 6–7 years extension study received risedronate 5 mg/day. Endpoints included vertebral and nonvertebral fracture assessments, changes in biochemical markers of bone turnover, and bone mineral density (BMD) measurements. A total of 164 women (placebo/risedronate group, 81; risedronate group, 83) entered the 6–7 years extension study and 136 (83%) completed the study. Annualized incidence of new vertebral fractures during the 6–7 years was similar between the 2 treatment groups (3.8%). The incidence of vertebral fractures did not change in the 7-year risedronate group during the 6–7 years as compared to 4–5 years, while a significant reduction was observed in the placebo group that switched to risedronate treatment during years 6–7. The incidence of nonvertebral fractures was 7.4% and 6.0% in the placebo/risedronate and risedronate groups, respectively, during years 6–7. Urinary N-telopeptide decreased from baseline by 54% and 63% at 3 months and 7 years, respectively, in the risedronate group. The increases in BMD from baseline after 5 years of risedronate treatment were maintained or increased further during years 6–7; lumbar spine BMD after 5 and 7 years of risedronate treatment increased from baseline by 8.8% and 11.5%, respectively, for this extension study population. Risedronate was well tolerated and the occurrence of upper gastrointestinal adverse events was low. After 7 years of continuous risedronate treatment there were significant increases in BMD and decreases in bone turnover to within premenopausal levels and there was no indication of any loss of anti-fracture efficacy. 相似文献
20.
Cost-effectiveness of risedronate for the treatment of osteoporosis and prevention of fractures in postmenopausal women 总被引:7,自引:7,他引:0
Randomized, double-blind, controlled studies have shown that treatment with risedronate reduces the risk of vertebral fracture in postmenopausal women with established vertebral osteoporosis. They also show that the drug decreases the risk of non-vertebral fractures in women with osteoporosis. The aim of this study was to investigate the cost-effectiveness of risedronate in postmenopausal women with osteoporosis. A Markov model was applied to a UK setting. Treatment effects were computed by meta-analysis of randomized, controlled trials and given over 5 years to subjects aged between 60 and 80 years. Quality-adjusted life years (QALYs) and life years gained were used as outcome measures. Intervention with risedronate was cost-effective in women aged 60 years and older. Cost savings were also found for postmenopausal women aged 70 years and older with established vertebral osteoporosis (a prior spine fracture and BMD T-score –2.5 SD). This treatment was cost-effective for women aged 65 years and older who had a prior vertebral fracture and a BMD T-score at the threshold of osteoporosis (T-score=–2.5 SD), and in women with a T-score–2.5 SD, but without a prior vertebral fracture. In women aged 60–80 years and at the threshold of osteoporosis (T-score=–2.5 SD) but without a prior vertebral fracture, treatment exceeded the threshold for cost-effectiveness. However, if an additional, independent risk factor was assumed (e.g., corticosteroid use) treatment became cost-effective. 相似文献