scholarly journals SUN-377 Efficacy of Low Dose Denosumab in Maintaining Bone Mineral Density in Postmenopausal Women with Osteoporosis: A Real World, Prospective Observational Study

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Aliya Aziz Khan ◽  
Hajar Abu Alrob ◽  
Iman M’Hiri ◽  
Hosay Said ◽  
Sharjil Hussain ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Monoclonal Antibody ◽  
Single Dose ◽  
Lumbar Spine ◽  
Postmenopausal Women ◽  
Low Dose ◽  
Human Monoclonal Antibody ◽  
Mineral Density ◽  
Percent Change ◽  
The Mean

Abstract Introduction: Denosumab, a fully human monoclonal antibody to RANK-ligand, has been shown to increase bone mineral density (BMD) and reduce the risk of hip, vertebral and non-vertebral fractures in postmenopausal women with osteoporosis (1-3). Varying doses of denosumab including 30mg/3months have demonstrated a decrease in bone remodelling in a dose-dependent manner (2,4-6). The primary objective of this study is to evaluate the efficacy of low dose denosumab (30mg/6 months) in postmenopausal women with osteoporosis who are reluctant to consider or continue the full dose of denosumab due to adverse events (AE) or concerns of potential AE. Methods: Following informed consent, postmenopausal women with a T-score of ≤ -2.5 at the lumbar spine (LS) or at the total hip (TH) received denosumab 30mg/6months. Patients with an additional skeletal disorder, prior fragility fracture, or on oral steroids (daily in the past 12 months) were excluded. The primary endpoint was the percent change in BMD at the lumbar spine (LS), total hip (HP), femoral neck (FN) and 1/3 radius (1/3R) at 12 months. Secondary outcomes were 1) percent change in BMD at the LS, TH, FN, and 1/3R at 24 months and 2) AE. Results: We enrolled 183 patients. The mean age was 69 years (SD= 7.07), 80% of patients had a moderate fracture risk (CAROC tool), 3% were current smokers and 9% consumed alcohol daily. 14.4% of patients were on SSRI/SNRI, 9.6% were on PPI, and no patient was on an aromatase inhibitor. At 12 months (n=125), the mean BMD significantly increased by +2.0% (95% CI 2.8%-1.3%) at the LS (p<0.001). There was no significant change in BMD at the FN, TH, AND 1/3R. At 24 months (n=65), the percent change in BMD was +3.4% (95% CI 4.8%-2.0%: p<0.001) at the LS, +1.5% (95% CI 2.9%-0.15%: p=0.031) at the FN, +1.9% (95% CI 3.5%-0.24%: p=0.025) at the 1/3R. There was no significant change in BMD at the TH. Conclusion: Low dose denosumab appears to be effective in maintaining BMD in postmenopausal women with a moderate fracture risk and may be of benefit in individuals who are experiencing side effects or concerns of side effects. This may also be of value following 10 years of therapy in order to maintain BMD. References 1.Bekker, PJ, Holloway DL, Rasmussen AS, Murphy R, Martin SW, Leese PT... Depaoli AM. A Single-Dose Placebo-Controlled Study of AMG 162, a Fully Human Monoclonal Antibody to RANKL, in Postmenopausal Women. JBMR, 2004;19(7), 1059-1066. 2.Kumagai Y, Hasunuma T, Padhi D. A randomized, double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of denosumab administered subcutaneously to postmenopausal Japanese women. Bone, 2011;49(5), 1101-1107. 3.Lewiecki EM, Miller PD, Mcclung MR, Cohen SB, Bolognese MA, Liu Y, . . . Fitzpatrick LA. Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. JBMR, 2007;22(12), 1832-1841.

scholarly journals Quality of Life in Postmenopausal Women and Its Correlation with Bone Mineral Density

2015 ◽  
Vol 26 (3) ◽  
pp. 58-64
Author(s):  
C Zonunsanga ◽  
Hmingthanmawii LNU ◽  
Minggam Pertin ◽  
Chongreilen Chiru ◽  
Romi Singh Nongmaithem ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Mineral Density ◽  
Significant Positive Association ◽  
The Mean

Abstract Aim To evaluate the quality of life in postmenopausal women and its correlation with bone mineral density. Study design Cross-sectional study. Duration of the study October 2012 to September 2014. Settings Physical Medicine and Rehabilitation Department, Regional Institute of Medical Sciences, Imphal. Study population Postmenopausal women who attended the department during the study period. Materials and Methods Quality of life was assessed using WHOQOL-BREF questionnaire, a validated brief version of the WHOQOL-100. Bone mineral density (BMD) in the lumbar spine, femoral neck and trochanter were measured using dual energy x-ray absorptiometry (DEXA) scan – GE Lunar model. Results A total of 125 patients were studied. The mean t-scores in lumbar spine, femoral neck and trochanter were -2.550 ± 1.209, -1.831 ± 0.921 and -1.621 ± 1.064 respectively. The mean BMD (g/cm2) in lumbar spine, femoral neck and trochanter were 0.867 ± 0.144, 0.789 ± 0.131 and 0.682 ± 0.139 respectively. The mean overall WHOQOL score was 57.68±10.07. There were statistically significant positive association of WHOQOL score with the BMDs in lumbar spine, femoral neck and trochanter (p < 0.05). Multivariate regression showed significant relation of overall WHOQOL score with BMD lumbar spine (b=0.229; R2=0.119), BMD femoral neck (b=0.285; R2=0.129), and BMD trochanter (b=0.245; R2=0.119). Conclusion BMDs in the lumbar spine, femoral neck and trochanter had a positive correlation with quality of life scores. BMD also had a good predictive value in determining the quality of life in postmenopausal women.

scholarly journals Effect of Raloxifene on Bone Mineral Density in Premenopausal Women at Increased Risk of Breast Cancer

2006 ◽  
Vol 91 (10) ◽  
pp. 3941-3946 ◽  
Author(s):  
J. Eng-Wong ◽  
J. C. Reynolds ◽  
D. Venzon ◽  
D. Liewehr ◽  
S. Gantz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Bone Mineral ◽  
Premenopausal Women ◽  
Spine Density ◽  
Mineral Density ◽  
Percent Change ◽  
Increased Risk ◽  
The Mean

Abstract Context: Raloxifene is a promising breast cancer prevention agent in postmenopausal women at increased risk for breast cancer. The effects of raloxifene in premenopausal women are unknown. Objective: We evaluated the effect of raloxifene in premenopausal women at increased risk for breast cancer on bone mineral density (BMD). Design: This was a phase II clinical trial. Setting: This study was conducted at an academic medical center. Participants: Thirty-seven premenopausal women at increased risk for breast cancer enrolled in the trial. Thirty subjects began treatment and 27 were evaluable. Intervention: Raloxifene (60 mg daily) and elemental calcium (500 mg daily) were given for 2 yr. Subjects were followed up off medications for 1 yr. Main Outcome Measure: The primary end point was the intrasubject percent change in BMD at 1 yr measured by dual-energy x-ray absorptiometry. Results: The mean baseline lumbar spine density was 1.027 g/cm2. Lumbar spine density decreased 2.3% at 1 yr (P &lt; 0.00001) and 3.5% at 2 yr (P &lt; .00001). Percent change from yr 2 to 3 was +1.4%. The mean baseline total hip bone density was 0.905 g/cm2. Total hip density decreased 0.3% at 1 yr and 1.0% at 2 yr (P = 0.033). Percent change from yr 2 to 3 was +1.7%. Conclusions: Raloxifene use is associated with a decrease in BMD in premenopausal women at increased risk for breast cancer. The clinical significance of this decrease is unknown and is attenuated with stopping raloxifene.

scholarly journals Efficacy of Low Dose Denosumab in Maintaining Bone Mineral Density in Postmenopausal Women With Osteoporosis Switching From 60mg to 30mg 6 Monthly: A Real World, Prospective Observational Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A240-A241
Author(s):  
Aliya Khan ◽  
Hajar Abu Alrob ◽  
Hosay Said ◽  
Salman Iqbal ◽  
Ismail Hweija ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Observational Study ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Low Dose ◽  
Human Monoclonal Antibody ◽  
P Value ◽  
Mineral Density ◽  
Risk Of Fracture ◽  
Increased Risk

Abstract Introduction: Denosumab, a fully human monoclonal antibody to RANK-ligand, has been shown to increase bone mineral density (BMD) and reduce the risk of fracture in postmenopausal women with osteoporosis. Cessation of denosumab is associated with rises in bone remodelling, reductions in BMD and an increased risk of fracture. The primary objective of this study is to evaluate the efficacy of low dose denosumab (30mg/6 months) in preventing bone loss in postmenopausal women with osteoporosis switching from 60mg to 30mg every 6 months. We report the effects of low dose denosumab for upto 2years in patients previously treated with denosumab for &gt;=3 years as well as &lt; 3years. Methods: Following informed consent, postmenopausal women with osteoporosis who had been on denosumab 60mg every 6 months were switched to receive 30mg of denosumab every 6 months.. Patients with an additional skeletal disorder, prior fragility fracture, or on oral steroids (daily in the past 12 months) were excluded. The primary endpoint was the percent change in BMD at the lumbar spine (LS), total hip (HP), femoral neck (FN) and 1/3 radius (1/3R) at 12 and 24 months. Secondary outcomes were adverse effects and fracture Results: 127 patients were included in the study. 44 patients had received 60 mg for 3 years or longer before transitioning to 30mg and 83 patients switched before completing 3 years on full dose therapy. Patients on less than 3yrs of 60mg therapy before the switch showed a significant improvement in BMD at LS (+2.00%, 95% CI 0.49% to 3.51%, n = 55, p-value = 0.01) 1 year post transition. There were no significant changes at the FN, TH or 1/3 radial sites 1 year post transition compared to baseline. At 2 years post transition (n=35) significant changes were noticed at LS (+4.65%, 95% CI 2.29% to 7.01%, p value &lt;0.001), FN (+ 4.87%, 95% CI 1.46% to 8.28%, p value = 0.006) and 1/3 radial sites (+4.95%, 95% CI 0.73% to 9.17%, p value = 0.02). No significant changes were noted at TH. Similar results were seen with prior denosumab therapy for &lt;3years No fractures were observed in this observational study. Conclusions: Switching from 60mg of denosumab to 30 mg every 6 months was not associated with reductions in BMD and may be a valuable treatment option in patients who have completed long term denosumab therapy.

Effect of tamoxifen on bone mineral density measured by dual-energy x-ray absorptiometry in healthy premenopausal and postmenopausal women.

1996 ◽  
Vol 14 (1) ◽  
pp. 78-84 ◽  
Author(s):  
T J Powles ◽  
T Hickish ◽  
J A Kanis ◽  
A Tidy ◽  
S Ashley
Keyword(s):  
Breast Cancer ◽  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Premenopausal Women ◽  
Dual Energy ◽  
Mineral Density ◽  
X Ray ◽  
The Mean

PURPOSE Tamoxifen is an effective treatment for metastatic and primary breast cancer and is now being evaluated as a chemoprevention agent in healthy women. Any long-term effects on estrogen-sensitive tissues such as bone may have important therapeutic implications. METHODS We measured bone mineral density (BMD) in the lumbar spine and hip using dual-energy x-ray absorptiometry (DXA) in premenopausal and postmenopausal healthy women who participated in our placebo-controlled tamoxifen chemoprevention of breast cancer trial. RESULTS BMD data are now available from 179 women for this analysis. In premenopausal women, BMD decreased progressively in the lumbar spine (P < .001) and in the hip (P < .05) for women on tamoxifen, but not those on placebo. The mean annual loss in lumbar BMD per year over the 3-year study period in tamoxifen-treated compliant women who remained premenopausal throughout the study period was 1.44% (1.88% calculated on an intent-to-treat basis) compared with a small gain of 0.24% per annum for women on placebo (P < .001). Tamoxifen had the opposite effect in postmenopausal women. The mean annual increase in BMD for women on tamoxifen was 1.17% in the spine (P < .005) and 1.71% in the hip (P < .001) compared with a noninsignificant loss for women on placebo. CONCLUSION These results indicate that tamoxifen treatment is associated with a significant loss of BMD in premenopausal women, whereas it prevents bone loss in postmenopausal women. These adverse and beneficial effects of tamoxifen should be considered in the assessment of the therapeutic benefits for both the adjuvant treatment and the chemoprevention of breast cancer.

scholarly journals Nonassociation of Estrogen Receptor Genotypes with Bone Mineral Density and Estrogen Responsiveness to Hormone Replacement Therapy in Korean Postmenopausal Women

1997 ◽  
Vol 82 (4) ◽  
pp. 991-995 ◽  
Author(s):  
Ki Ok Han ◽  
In Gul Moon ◽  
Young Soon Kang ◽  
Ho Yeon Chung ◽  
Hun Ki Min ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Estrogen Receptor ◽  
Hormone Replacement Therapy ◽  
Lumbar Spine ◽  
Replacement Therapy ◽  
Postmenopausal Women ◽  
Gene Locus ◽  
Restriction Site ◽  
Hormone Replacement ◽  
Mineral Density

Abstract Hormone replacement therapy (HRT) prevents bone loss in postmenopausal women, but some women are resistant to therapy. A recently reported case of severe estrogen resistance caused by a germ-line mutation at the estrogen receptor (ER) gene locus suggests the possibility that other variants of the ER gene could be responsible for resistance to HRT and could also be an answer to the heritable components of bone density. Three restriction fragment length polymorphisms (RFLPs) at the ER gene locus, represented as BstUI (or B variant), PvuII, and XbaI, and their relationship to bone mineral density (BMD) and estrogen responsiveness to HRT were examined in 248 healthy postmenopausal women, aged 41–68 yr (mean± sd, 52.0 ± 4.6 yr) in Korea. The BstUI restriction site was not found in Korean women. The distribution of the PvuII and XbaI RFLPs was as follows: PP, 35 (14.1%); Pp, 136 (54.8%); pp, 77 (31.1%); and XX, 18 (7.3%); Xx, 72 (29.0%); and xx, 158 (63.7%), respectively (capital letters signify the absence of and lower case letters signify the presence of the restriction site of each RFLP). There was no significant relation between ER genotypes and z score values of lumbar spine BMD. Also, no significant genotypic differences were found in the change in lumbar spine BMD and those in biochemical markers before and after 1 yr of HRT. These data indicate no significant effects of ER genotypes on BMD and estrogen responsiveness after HRT.

Estimation of Central Osteopenia in Children With Chronic Polyarthritis Treated With Glucocorticoids

PEDIATRICS ◽  
1993 ◽  
Vol 91 (6) ◽  
pp. 1127-1130
Author(s):  
Antero Kotaniemi ◽  
Anneli Savolainen ◽  
Hannu Kautiainen ◽  
Heikki Kröger
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Bone Mineral ◽  
Bone Size ◽  
Mineral Density ◽  
Volumetric Density ◽  
Chronic Polyarthritis ◽  
The Mean ◽  
Bone Volumetric Density

Study objective. To investigate the degree and determinants of osteopenia in juvenile chronic polyarthritis. Design. Retrospective case-control study of central bone mineral density. Setting. Rheumatism Foundation Hospital and Kuopio University Hospital, Finland. Subjects. A sample of 43 girls aged 7 to 19 with juvenile chronic polyarthritis treated with systemic glucocorticoids and a control sample of 44 healthy girls matched for age. Main outcome measures. Bone mineral density and bone size (width) measured by dual-energy x-ray absorptiometry and bone volumetric density calculated as an approximation of true bone density at both the lumbar spine and femoral neck. Results. The girls with juvenile chronic arthritis had reduced bone mineral density, bone size, and bone volumetric density at both the lumbar spine and femoral neck (statistically significant findings, P = .022 for the bone size of the femoral neck and P &lt; .001 for the other parameters). At the spine, the mean bone mineral density was 80%, the mean bone size 89%, and the mean bone volumetric density 89% of the values in the control group. At the femoral neck, the values were 78%, 93%, and 83%, respectively. The groups were matched for age, but the girls with arthritis were smaller and lighter. In the juvenile arthritis group, the femoral bone mineral density and bone volumetric density and the spinal bone width correlated negatively with the mean glucocorticoid dose. Conclusion. Axial bone mineral density is clearly reduced in severe juvenile polyarthritis and is mediated by both decreased bone volumetric density and diminished growth.

scholarly journals BMD status of Postmenopausal Women in relation with BMI: A study with 93 cases

2016 ◽  
Vol 17 (2) ◽  
pp. 138-141
Author(s):  
Samira Sharmin ◽  
Mabubul Haque ◽  
Syedur Rahman Miah ◽  
Md Mahbub Ur Rahman ◽  
Jasmine Ara Haque ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Femoral Neck ◽  
Postmenopausal Women ◽  
Lumbar Vertebrae ◽  
The Body ◽  
Mineral Density ◽  
Cross Sectional ◽  
T Score ◽  
Minimal Trauma ◽  
The Mean

Objectives: Low bone mass is a common disorder in elderly population which predisposes to fracture with minimal trauma. This study was performed to find out the association between the Body Mass Index (BMI) and Bone Mineral Density (BMD) in postmenopausal women.Materials and Methods: This cross sectional study was carried out at Institute of Nuclear Medicine and Allied Sciences Comilla and Mitford, Dhaka over a period of 12 months from January 2013 to December 2013. A total 93 postmenopausal women were enrolled for this study. All postmenopausal women underwent a BMD scan of femoral neck and lumbar vertebrae using a Dual Energy X-ray Absorptiometry (DEXA). Participants were categorized into three groups according to their age and BMI. BMD were expressed base on T-score according to WHO criteria. The relation among BMI, age and BMD were assessed.Results: The results of this study showed that the mean age of the study group was 57.13±7.49 years with range of 46 to 75 years. The most postmenopausal women were in age group 55-65years. The mean BMI of the study subjects were 24.18±5.08 kg/m2 with a range of 15.62 to 36.20 kg/m2. Among 93 subjects osteopenia was greater at lumbar spine (45.2%) with T-score mean±SD-1.83±0.33 and osteoporosis at femoral neck (51.6%) with T-score mean ±SD-3.36±-0.67. Pearson’s correlation coefficient test showed inverse relationship between age and BMD both lumbar spine (r = -0.301, p = 0.003) and femoral neck (r = -0.303, p=0.003) whereas the positive relation between BMI and BMD both at lumbar spine (r=0.338, p=0.001) and femoral neck (r =0.343, p=0.001). These showed that with advancing age, BMD decreases and the risk of osteoporosis increases and with increasing BMI, BMD increases and risk of osteoporosis decreases.Conclusion: The findings of this study portrait that aging and low BMI are risk factors associated with bone loss. So preventive measure should be taken for high risk post menopausal women.Bangladesh J. Nuclear Med. 17(2): 138-141, July 2014

scholarly journals TO DETERMINE THE PREVALENCE OF LOW BONE MINERAL DENSITY (OSTEOPENIA AND OSTEOPOROSIS) IN INDIAN PATIENTS WITH CIRRHOSIS OF LIVER AWAITING LIVER TRANSPLANTATION AS PER CURRENTLY USED HOLOGIC DXA DATABASE

2021 ◽  
Vol 5 (4) ◽  
Author(s):  
Sharad Deshmukh ◽  
Suchita Deshmukh ◽  
Sarojni A Parameswran ◽  
P Pirmanayagam ◽  
N Murgan ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Liver Transplantation ◽  
Lumbar Spine ◽  
Bone Mineral ◽  
Mineral Density ◽  
Low Bone Mineral Density ◽  
Indian Patients ◽  
History Of ◽  
The Mean ◽  
Cirrhosis Of Liver

Background: Abnormalities in the bone metabolism observed in chronic liver disease are referred to as hepatic osteodystrophy. Osteoporosis and osteopenia are each part of this condition. Both conditions have a significant impact on morbidity, causing fractures that may result in chronic pain, long-lasting immobility, and deformity. Prevalence of fracture in patients with liver transplantation ranges from 15% - 65%. A high rate of fracturing is seen within the initial 1–2 years after transplantation. Aim: To determine the prevalence of low bone mineral density (osteopenia and osteoporosis) in Indian patients with cirrhosis of liver awaiting liver transplantation as per currently used Hologic DXA database Methods: This was a prospective observational study done at the department of gastroenterology and hepatology, Apollo Hospitals, Chennai from April 2011 to March 2013. All patients who fulfilled the inclusion criteria underwent detailed history taking, physical examination and relevant laboratory investigations. One hundred patients were selected for the scope of the study. Results: Sixty-eight per cent of patients were in the age group of 45 to 65 years. The mean age ± SD of the study subjects was 51.2 ± 9.7 years. The mean age for male patients was 50.5 ± 10.1 years, and for females was 54 ± 7.3 years. Cirrhosis was due to alcohol in 36% of the patients, viral hepatitis in 28% (HBV in 10% and HCV in 18%) patients. 42% were in Child’s class B, and the remaining 58% were in Child’s class C. MELD score was less than 20 in 62% patients. One third was diabetic; one third gave the history of backache. History of smoking was present in one fifth (20%) patients, and a history of fracture (most of them were traumatic) was present in 13% of patients. By using Hologic DXA database at the lumbar spine, osteopenia and osteoporosis were diagnosed in 44% and 38 % patients respectively. At the femoral neck, osteopenia and osteoporosis were diagnosed in 45% and 9% of patients. By using ICMR database at the lumbar spine, osteopenia and osteoporosis were diagnosed in 38% and 17% patients respectively. Similarly, at the femoral neck, osteopenia and osteoporosis were diagnosed in 34% and 5%. By using the Hologic DXA database, osteopenia and osteoporosis were diagnosed in 42% and 40 % patients. By using ICMR database, osteopenia and osteoporosis were diagnosed in 43% and 19% patients respectively. Conclusion: In light of the above results, the present study revealed a high prevalence of low bone mineral density (osteopenia and osteoporosis) in Indian patients with cirrhosis of liver awaiting liver transplantation. The lumbar spine was the most frequently and severely affected site in hepatic osteodystrophy. Keywords: Osteopenia, Osteoporosis, Low Bone Mineral Density, Liver Cirrhosis

scholarly journals Breast Safety and Efficacy of Genistein Aglycone for Postmenopausal Bone Loss: A Follow-Up Study

2008 ◽  
Vol 93 (12) ◽  
pp. 4787-4796 ◽  
Author(s):  
Herbert Marini ◽  
Alessandra Bitto ◽  
Domenica Altavilla ◽  
Bruce P. Burnett ◽  
Francesca Polito ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Postmenopausal Women ◽  
Sister Chromatid ◽  
Safety Profile ◽  
Sister Chromatid Exchange ◽  
Endometrial Thickness ◽  
Mineral Density ◽  
Brca1 And Brca2

Context: Genistein aglycone improves bone metabolism in women. However, questions about the long-term safety of genistein on breast as well as its continued efficacy still remain. Objective: We assessed the continued safety profile of genistein aglycone on breast and endometrium and its effects on bone after 3 yr of therapy. Design: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24-months. Subsequently, a subcohort (138 patients) continued therapy for an additional year. Patients and Interventions: Participants received 54 mg of genistein aglycone daily (n = 71) or placebo (n = 67). Both treatment arms received calcium and vitamin D3 in therapeutic doses. Main Outcomes: Mammographic density was assessed at baseline, 24 and 36 months by visual classification scale and digitized quantification. BRCA1 and BRCA2, sister chromatid exchange, and endometrial thickness were also evaluated. Lumbar spine and femoral neck bone mineral density were also assessed. Secondary outcomes were biochemical levels of bone markers. Results: After 36 months, genistein did not significantly change mammographic breast density or endometrial thickness, BRCA1 and BRCA2 expression was preserved, whereas sister chromatid exchange was reduced compared with placebo. Bone mineral density increases were greater with genistein for both femoral neck and lumbar spine compared to placebo. Genistein also significantly reduced pyridinoline, as well as serum carboxy-terminal cross-linking telopeptide and soluble receptor activator of NF-κB ligand while increasing bone-specific alkaline phosphatase, IGF-I, and osteoprotegerin levels. There were no differences in discomfort or adverse events between groups. Conclusions: After 3 yr of treatment, genistein exhibited a promising safety profile with positive effects on bone formation in a cohort of osteopenic, postmenopausal women.

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