scholarly journals Effects of once-yearly zoledronic acid on bone density and incident vertebral fractures in nonmetastatic castration-sensitive prostate cancer patients with osteoporosis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Daisuke Watanabe ◽  
Takahiro Kimura ◽  
Ken Watanabe ◽  
Hiromitsu Takano ◽  
Yuko Uehara ◽  
...  

Abstract Background Androgen deprivation therapy (ADT) is the effective treating prostate cancer but is often accompanied by cancer treatment-induced bone loss (CTIBL), which impairs the patient’s quality of life. In patients with nonmetastatic castration-sensitive prostate cancer (M0CSPC) who already have osteoporosis before starting ADT, appropriate bone-modifying agent intervention must be performed in parallel, as the patient has a high risk of future fracture. However, little is known about therapeutic interventions aimed at preventing the progression of CTIBL and new fractures. The present study explored the effect of once-yearly zoledronic acid 5 mg (ZOL 5 mg) on bone mineral density (BMD) and new vertebral fractures (VFs) in M0CSPC patients with coexisting osteoporosis before starting ADT. Methods We conducted a retrospective, multi-institutional, cohort study involving 42 M0CSPC patients with osteoporosis who had undergone ADT with/without a single intravenous infusion of ZOL 5 mg at the start of ADT (ZOL 5 mg group, n = 26; control group, n = 16). The association of the ZOL 5 mg with changes in the BMD from baseline to 12 months and the incidence of VFs were evaluated. Results Prevalent VFs were found in 47.6% of all patients at baseline. ZOL 5 mg significantly increased the lumbar spine BMD (LS-BMD) (mean rate of change: + 4.02%, p < 0.0001) and significantly decreased the TRACP-5b (mean rate of change: − 52.1%, p < 0.0001) at 12 months after starting ADT. Incident VFs were identified in 19.0% of all patients at 12 months after starting ADT. After adjusting for the age, BMI, and changes in the LS-BMD, ZOL 5 mg was not significantly associated with incident VFs (odds ratio 0.66, 95% confidence interval 0.04–11.3, p = 0.7774). Conclusion ZOL 5 mg significantly increased the LS-BMD 12 months after starting ADT, and our short-term results showed that ZOL 5 mg was not significantly correlated with the suppression of incident vertebral fractures.

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14568-14568
Author(s):  
V. R. Phooshkooru ◽  
H. J. Spencer ◽  
M. Kohli

14568 Background: Evidence for preventing androgen deprivation (AD) induced osteoporosis with bisphosphonate therapy in prostate cancer patients has emerged largely from trials conducted in caucasian patients. Osteoporosis related skeletal event incidence in African Americans (AA) receiving AD is significantly lower than caucasians and the effect of bisphosphonates therapy uncertain. We conducted a prospective study to evaluate the efficacy of zoledronic acid in preventing osteoporosis in racially diverse population receiving AD. Methods: Asymptomatic, prostate cancer patients (16 caucasians and 6 AA) with normal renal function undergoing AD, started within the last 9 months were randomized to receive (Arm A) CaCO3/vitamin D (500 mg/200U TID) or (Arm B) CaCO3/vitamin D and zoledronic acid (4 mg IV every 3 months for a year). Bone turnover markers including urine N-telopeptide, serum osteocalcin, serum bone specific alkaline phosphatase(BsAP) were serially measured every 3 months and bone mineral density (BMD) measured by DXA at hip, femur, spine and ward’s triangle at 0, 6 and 15 month intervals. Primary endpoint was to obtain BMD changes and bone turnover rates for each treatment arm. Nonparametric methods for analyzing longitudinal data were used to compare DXA-derived BMD measures and bone turnover rate markers in patients receiving zoledronic acid to the control group. Results: Data is presented for 16/22 patients who have completed 15- month follow up. Time trend analysis of bone formation (BsAP, osteocalcin) and resorption (N-telopeptide) markers and DXA measurements of BMD (spine and hip) are shown in the table. Conclusions: This study suggests that zoledronic acid preserves BMD at spine in racially diverse patients and, likewise provides preliminary estimates of BMD changes that occur over 15 months in patients receiving zoledronic acid and placebo. Larger AA cohorts are needed for prospective validation of the observed effect with zoledronic acid. [Table: see text] [Table: see text]


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Weiran Hu ◽  
Hongqiang Wang ◽  
Xinge Shi ◽  
Yuepeng Song ◽  
Guangquan Zhang ◽  
...  

Introduction. This study aimed to compare and analyze the effect of preoperative zoledronic acid (ZOL) administration on pain intensity after percutaneous vertebroplasty (PVP) for osteoporotic vertebral compression fracture (OVCF). Methods. The study included 242 patients with OVCFs who underwent PVP in our hospital between January 2015 and June 2018. The patients were randomly assigned to either a ZOL group (n = 121) or a control group (n = 121). The patients in the ZOL group were treated preoperatively with intravenous infusion of 5 mg ZOL. Those in the control group were treated without ZOL. All the patients were followed up for 1 year. Results. No statistically significant differences in age, sex, weight, and body mass index (BMI) were found between the two groups. During the follow-up period, the visual analog scale score and Oswestry dysfunction index score in the ZOL group were lower than those in the control group. The bone mineral density at 6 or 12 months after treatment was significantly higher and the levels of the bone metabolism markers were significantly lower in the ZOL group than in the control group (P<0.05 for both). Two patients in the treatment group had new vertebral fractures, whereas 13 patients in the control group had new vertebral fractures, which translate to recompression vertebral fracture incidence rates of 1.7% and 10.7%, respectively. The incidence rate of mild adverse reactions was significantly higher in the ZOL group than in the control group, but all the cases were endurable. Conclusion. Intravenous infusion of ZOL before PVP can effectively reduce postoperative pain intensity, reduce bone loss, increase bone density, reduce the risk of refracture, and improve patient quality of life.


2020 ◽  
Vol 20 (13) ◽  
pp. 1604-1612
Author(s):  
Congcong Wu ◽  
Hua Jiang ◽  
Jianghua Chen

Background: Although the adjuvant therapy of bisphosphonates in prostate cancer is effective in improving bone mineral density, it is still uncertain whether bisphosphonates could decrease the risk of Skeletal- Related Event (SRE) in patients with prostate cancer. We reviewed and analyzed the effect of different types of bisphosphonates on the risk of SRE, defined as pathological fracture, spinal cord compression, radiation therapy to the bone, surgery to bone, hypercalcemia, bone pain, or death as a result of prostate cancer. Methods: A systemic literature search was conducted on PubMed and related bibliographies. The emphasis during data extraction was laid on the Hazard Ratio (HR) and the corresponding 95% Confidence Interval (CI) from every eligible Randomized Controlled Trial (RCT). HR was pooled with the fixed effects model, and preplanned subgroup analyses were performed. Results: 5 RCTs (n = 4651) were included and analyzed finally after screening 51 articles. The meta-analysis of all participants showed no significant decrease in the risk of SRE when adding bisphosphonates to control group (HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536) with low heterogeneity (I2 = 0.0% (d.f. = 4) p = 0.679). There was no significant improvement on SRE neither in the subgroups with Metastases (M1) or Castration-Sensitive Prostate Cancer (CSPC) (respectively HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536, I2 = 0.0% (d.f. = 4) p = 0.679; HR = 0.954, 95% CI = 0.837 - 1.088, p = 0.484, I2 = 0.0% (d.f. = 3) p = 0.534). Conclusion: Our study demonstrated that bisphosphonates could not statistically significantly reduce the risk of SRE in patients with prostate cancer, neither in the subgroups with M1 or CSPC.


2021 ◽  
Author(s):  
Allen Herng Shouh Hsu ◽  
Chun-Hsien Yen ◽  
Yu-Der Lu ◽  
Feng-Chih Kuo ◽  
Cheng-Ta Wu ◽  
...  

Abstract Background: Previous study has shown that a short-term use of zoledronic acid (ZA) after cementless total hip arthroplasty (THA) significantly increases bone mineral density (BMD) over the proximal femur and inhibits bone turnover markers (BTMs) after two years. However, could the discontinuation of ZA have a lasting effect is of interest.Method: This is an extension study of a two-year prospective randomized controlled trial on 54 cementless THA treated with either two doses of ZA or placebo. We compared BTMs [alkaline phosphatase (ALP); osteocalcin (OC); procollagen 1 intact N-terminal propeptide (P1NP)], serum calcium, renal function, radiological findings, and functional outcomes (Harris hip score and UCLA activity score) from baseline to 5 years post-THA in 49 patients, and periprosthetic BMD of the seven Gruen zones in 19 patients.Result: All patients had well-functioning hip prostheses, normal renal function, and normal serum calcium levels at 5-year follow-up. At the fifth year, the BMD levels were not statistically different between the two groups, but the change in BMD from baseline (BMD change ratios) in ZA group were significantly increased in zone 2, 4, and 6 as compared with control group. Parallel to that, in ZA group, levels of ALP were significantly lower at the fifth year; OC were significantly lower at the second and the fifth year; P1NP were significantly lower from 6 weeks to 2 years as compared with those in control group.Conclusion: This study demonstrates the lasting effect of a two-dose ZA given within one year after THA on bone metabolism and periprosthetic BMD at five years. The short-term dosing of ZA followed by a 4-year drug holiday had no adverse events and resulted in significant inhibition of periprosthetic bone loss and BTMs.Trial Registration:This extension study on a randomized, open label, single-center clinical trial was conducted under Institutional Review Board of Chang Gung Memorial Hospital Protocol Records 98-1150A3; 105-1296C1; 105-7004D, and was registered July 19th, 2016 on public registry ClinicalTrials.gov trial registration number NCT02838121.


2007 ◽  
Vol 25 (9) ◽  
pp. 1038-1042 ◽  
Author(s):  
M. Dror Michaelson ◽  
Donald S. Kaufman ◽  
Hang Lee ◽  
Francis J. McGovern ◽  
Philip W. Kantoff ◽  
...  

Purpose Gonadotropin-releasing hormone (GnRH) agonists decrease bone mineral density (BMD) and increase fracture risk in men with prostate cancer. Annual zoledronic acid increases BMD in postmenopausal women, but its efficacy in hypogonadal men is not known. Patients and Methods In a 12-month study, 40 men with nonmetastatic prostate cancer who were receiving a GnRH agonist and had T scores more than −2.5 were randomly assigned to zoledronic acid (4 mg intravenously on day 1 only) or placebo. BMD of the posteroanterior lumbar spine and proximal femur were measured by dual-energy x-ray absorptiometry. Results Mean (± SE) BMD of the posteroanterior lumbar spine decreased by 3.1% ± 1.0% in men assigned to placebo and increased by 4.0% ± 1.0% in men assigned to zoledronic acid (P < .001). BMD of the total hip decreased by 1.9% ± 0.7% in men assigned to placebo and increased by 0.7% ± 0.5% in men assigned to zoledronic acid (P = .004). Similar between-group differences were observed for the femoral neck and trochanter. Serum N-telopeptide, a marker of osteoclast activity, decreased significantly after zoledronic acid treatment. Conclusion In men receiving a GnRH agonist, a single treatment with zoledronic acid significantly increased BMD and durably suppressed serum N-telopeptide levels for 12 months. Annual zoledronic acid may be a convenient and effective strategy to prevent bone loss in hypogonadal men.


2020 ◽  
Vol 36 (7) ◽  
Author(s):  
Li Kong ◽  
Kai Zuo ◽  
Long Ma

Objective: To investigate the clinical efficacy of zoledronic acid in the treatment of senile osteoporosis. Methods: One hundred and six cases of senile osteoporosis who visited to our hospital from August 2017 to December 2018 for treatment were selected and randomly divided into a control group and an observation group. The control group was treated with conventional therapy, while the observation group was treated with zoledronic acid in addition to the treatment of the control group. Bone mineral density, pain degree, therapeutic effect and adverse reactions of the two groups were compared. Results: The total effective rate of the observation group was 96.67%, higher than 80.00% of the control group (P<0.05); the bone mineral density of lumbar vertebrae, femoral neck and Ward’ area in the two groups increased after 6 months of treatment, and the bone mineral density of the observation group increased more than that of the control group (P<0.05); the pain degree of the observation group was lower than that of the control group after 6 months of treatment, and the difference was significant (P<0.05). There was no significant difference in the occurrence of adverse reactions between the two groups (P>0.05). Conclusion: Zoledronic acid is helpful to alleviate clinical symptoms, reduce the degree of bone pain, and promote the increase of bone mass, and has high safety in the treatment of senile osteoporosis, which is worth promotion. doi: https://doi.org/10.12669/pjms.36.7.1964 How to cite this:Kong L, Zuo K, Ma L. Clinical effect of Zoledronic Acid in the treatment of Senile Osteoporosis. Pak J Med Sci. 2020;36(7):1703-1707.   doi: https://doi.org/10.12669/pjms.36.7.1964 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


2021 ◽  
Vol 12 ◽  
Author(s):  
Yuhua Wen ◽  
Huijuan Li ◽  
Xiaoya Zhang ◽  
Peipei Liu ◽  
Jing Ma ◽  
...  

This study aimed to explore the risk factors attributed to osteoporosis in newly type 2 diabetes mellitus (T2DM) patients. This study aimed to recruit 244 T2DM patients and 218 non-diabetic controls. We collected demographic characteristics, medical history, bone mineral density and biomarkers including bone specific alkaline phosphatase (BALP), osteocalcin, N-terminal peptide of type I procollagen (P1NP), tartrate-resistant acid phosphatase 5b (TRCAP-5b), β-Cross Laps of type I collagen-containing cross-linked C-telopeptide (β-CTX), 25-hydroxyvitamin D, parathyroid hormone were recorded or detected. Bone mineral density (BMD) was our primary outcome. Based on the result of BMD, we divided both the control group and T2DM group into three subgroups: normal bone mass, osteopenia and osteoporosis. In control group, we found age, sex, menopausal status, BMI, P1NP, BALP, TRACP-5b, osteocalcin, and corrected serum calcium are differential among three subgroups. In T2DM group, we found age, sex, menopausal status, drinking status, BMI, HbA1c, TRACP-5b and OC were differential among three subgroups. In T2DM and control groups, age, female, postmenopausal status, BALP, TRACP-5b and osteocalcin were positively correlated while BMI was negatively correlated with osteoporosis. In control group, β-CTX was positively correlated with osteoporosis. In T2DM group, HbA1c and corrected serum calcium concentration were positively correlated with osteoporosis. After further adjustment of age, BMI in male, TRACP-5b was positively correlated with the risk of osteoporosis in newly diagnosed T2DM. After adjusted of age, BMI and menopausal status in female, OC was positively correlated with the risk of osteoporosis in newly diagnosed T2DM and controls. In female T2DM, BALP and P1NP were positively correlated with the risk of osteoporosis. In conclusion, age, BMI and menopausal status are common risk factors for osteoporosis in diabetic and non-diabetic patients, however TRACP-5b, BALP and osteocalcin are special risk factors for osteoporosis in newly diagnosed T2DM patients but not non-diabetic patients, which may be applied to identify osteoporosis risk in T2DM patients, but this result needs to be proven with fracture data.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 212-212
Author(s):  
A. K. Morgans ◽  
M. L. Hancock ◽  
G. Barnette ◽  
M. S. Steiner ◽  
R. A. Morton ◽  
...  

212 Background: In the general population, black men have higher bone mineral density (BMD) and lower fracture rates than white men. Whether race influences bone loss and fracture risk during androgen deprivation therapy (ADT) for prostate cancer is unknown. Using data from a recently completed prospective, randomized, clinical trial we compared BMD and fracture rates of black and white men receiving ADT for prostate cancer. Methods: Subjects in these analyses (n=516) were members of the placebo group of a two-year randomized controlled trial of toremifene to prevent fractures in men receiving ADT for prostate cancer. All subjects resided in United States and reported their race as either black (n=68) or white (n=448). We compared baseline characteristics, including BMD and prevalent vertebral fractures, between black (n=68) and white men (n=448). We also compared changes in BMD and rates of new vertebral fractures over the two year study period. Results: Black men had higher baseline hip BMD than white men (0.98 ± 0.15 g/m2 and 0.91 ± 0.15 g/m2, respectively; p=0.001). Black men had similar BMD of the spine (1.09 ± 0.22 g/m2 and 1.11 ± 0.22 g/m2 in black and white men, respectively; p=0.51), but fewer prevalent vertebral fractures (7.4% versus 15.0%; p=0.13). Changes in BMD from baseline to 24 months were similar between black and white men (total hip percentage change −2.54 ± 0.26 in white men and −2.09 ± 0.60 in black men; p=0.55; lumbar spine percentage change −1.30 ± 0.33 in white men and −1.67 ± 0.71 in black men; p<0.71). Rates of new vertebral fractures trended towards being lower in black men (1.15% of black men versus 4.83% of white men; relative risk 0.24; p<0.12). Conclusions: Among men receiving ADT for prostate cancer, black men had higher baseline BMD at the hip and fewer prevalent vertebral fractures. Changes in BMD during ongoing ADT were similar for black and white men. Consistent with lower baseline risk for fracture, however, black men had fewer new vertebral fractures than white men. [Table: see text]


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