scholarly journals Randomized Controlled Trial of Annual Zoledronic Acid to Prevent Gonadotropin-Releasing Hormone Agonist–Induced Bone Loss in Men With Prostate Cancer

2007 ◽  
Vol 25 (9) ◽  
pp. 1038-1042 ◽  
Author(s):  
M. Dror Michaelson ◽  
Donald S. Kaufman ◽  
Hang Lee ◽  
Francis J. McGovern ◽  
Philip W. Kantoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lumbar Spine ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Gnrh Agonist ◽  
Controlled Trial ◽  
Gonadotropin Releasing Hormone ◽  
Mineral Density ◽  
Releasing Hormone ◽  
Increase Fracture Risk

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.

Annual zoledronic acid to prevent gonadotropin-releasing hormone agonist-induced bone loss in men with prostate cancer: A randomized placebo-controlled trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4515-4515 ◽  
Author(s):  
M. D. Michaelson ◽  
H. Lee ◽  
D. S. Kaufman ◽  
P. W. Kantoff ◽  
J. Finkelstein ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Bone Mineral ◽  
Gnrh Agonist ◽  
Gonadotropin Releasing Hormone ◽  
Mineral Density ◽  
Total Hip

4515 Background: Gonadotropin-releasing hormone (GnRH) agonists decrease bone mineral density (BMD) and increase fracture risk in men with prostate cancer. Zoledronic acid (4 mg IV every 3 months) increases BMD in GnRH agonist treated men. Intermittent zoledronic acid (4 mg IV once annually) increases BMD in postmenopausal women with osteoporosis but the efficacy of the annual treatment schedule in hypogonadal men is unknown. Methods: In a 12-month open-label study, men with nonmetastatic prostate cancer (n = 44) who were receiving a GnRH agonist were assigned randomly to zoledronic acid (4 mg IV × 1) or placebo. BMD of the posteroanterior lumbar spine and total hip were measured by dual energy x-ray absorptiometry at baseline and month 12. Serum N-telopeptide, a marker of osteoclast activity, was measured every 3 months. Results: Mean (± SE) BMD of the posteroanterior lumbar spine increased by 4.0 ± 0.9 in men treated with zoledronic acid and decreased by 3.1 ± 0.9 percent in men who received placebo (P < 0.001 for between-group comparison). BMD of the total hip decreased by 0.7 ± 0.6 percent in men treated with zoledronic acid and decreased by 1.9 ± 0.7 percent in men who received placebo (P = 0.005). Compared to placebo, zoledronic acid significantly decreased serum N-telopeptide throughout the 12-month study (P < 0.05). Conclusions: In men receiving a GnRH agonist for prostate cancer, a single treatment of zoledronic acid significantly increased bone mineral density of the total hip and spine at 12 months. Annual zoledronic acid may provide a convenient and effective strategy to prevent bone loss in hypogonadal men. This study was supported in part by Novartis Oncology and by the Prostate Cancer Foundation. [Table: see text]

scholarly journals Protocol for a pilot randomised controlled trial of zoledronic acid to prevent bone loss following sleeve gastrectomy surgery

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e057483
Author(s):  
Laura E Flores ◽  
Lynn Mack ◽  
Christopher Wichman ◽  
Ashley A Weaver ◽  
Vishal Kothari ◽  
...  
Keyword(s):  
Sleeve Gastrectomy ◽  
Lumbar Spine ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Controlled Trial ◽  
Menopausal Status ◽  
Rapid Weight Loss ◽  
Mineral Density ◽  
Total Hip ◽  
Vitamin D Levels

IntroductionSleeve gastrectomy (SG) is an increasingly used and effective treatment for obesity; however, the rapid weight loss associated with SG adversely affects bone metabolism predisposing patients to skeletal fragility. Bisphosphonate medications have been evaluated for safety and efficacy in combating bone loss in patients with osteoporosis, but their use in SG-induced bone loss is limited. The goal of this study is to investigate how a one-time infusion of zoledronic acid compares to placebo, in its ability to combat SG-associated bone loss.Methods and analysisThis research protocol is a 9-month, pilot randomized controlled trial (RCT) involving 30 adult SG patients randomised to receive an infusion of either 5 mg of zoledronic acid or placebo, 6 weeks following surgery. To be included participants must be <350 lbs/158.8 kg, free of bone-impacting pathologies or medications, and must have adequate serum calcium and vitamin D levels at baseline. The primary outcome is change in areal bone mineral density (aBMD) at the total hip. Secondary outcomes include change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine. The primary aim will be tested using a linear mixed model fit with total hip aBMD at 9 months as the outcome. Treatment, participant sex and menopausal status will be considered in analysis. Groups will be compared using contrast statements at 9 months, with change over 9 months being the primary comparison.Ethics and disseminationThis study was approved by the Institutional Review Board of the University of Nebraska Medical Center (IRB820-19). Written consent will be obtained from participants at enrolment by trained staff. Careful and thorough explanation are used in obtainment of consent and voluntariness is emphasised throughout the trial. The findings of this study will be presented locally, nationally, and published in peer-reviewed journals. Additional details will be reported on ClinicalTrials.gov.Trial registration numberNCT04279392

The effects of intermittent androgen deprivation therapy (ADT) and zoledronic acid administration on bone density in patients with prostate cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15593-15593 ◽  
Author(s):  
L. Katznelson ◽  
K. Kent ◽  
S. Srinivas
Keyword(s):  
Prostate Cancer ◽  
Lumbar Spine ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Femoral Neck ◽  
Previous Treatment ◽  
Osteonecrosis Of The Jaw ◽  
Recurrent Prostate Cancer ◽  
Mineral Density ◽  
Acid Administration

15593 Background: Intermittent ADT is commonly used in men with recurrent prostate cancer. Bone loss associated with ADT is well described. Bisphosphonate use in men undergoing ADT results in improvement in bone mineral density (BMD), although the utility and duration of bisphosphonate use in men undergoing intermittent ADT are unclear. Objective:To evaluate the effect of zoledronic acid administration every 3 months on BMD in men with prostate cancer undergoing intermittent ADT, and whether BMD is maintained upon discontinuation of both ADT and zoledronic acid. Methods: Patients with recurrent prostate cancer starting ADT were eligible to participate. Subjects received ADT for 9 months in addition to 3 doses of zoledronic acid every 3 months. At 9 months, patients who achieved an undetectable serum PSA were taken off ADT and then randomized either to continuing zoledronic acid every 3 months for an additional 3 doses vs. observation. BMD, assessed by DEXA scan, was determined at baseline, 9 months, and between 18 -24 months at hip, trochanter, femoral neck and lumbar spine sites. Results: Twenty two patients were treated with ADT and zoledronic acid between 2003–2006. Seven of these subjects had bone metastases and had previous treatment with ADT.There was one infusion related reaction, and one patient developed osteonecrosis of the jaw and was removed from the study. At baseline, 3 patients had osteoporosis at the lumbar spine. All patients who received zoledronic acid for 9 months had an improvement in BMD at all 3 sites. In the 7 subjects who had previously received ADT, BMD of the femoral neck increased significantly by approximately 1.9%. Among the 6 patients randomized to continuing zoledronic acid after discontinuing ADT at 9 months, all had a further, significant increase in BMD. Those randomized to observation were unable to maintain their BMD and had continued bone loss despite stopping ADT. Conclusions: This small study demonstrated an increase/maintenance of BMD in men receiving intermittent ADT and zoledronic acid. Only those men who continued zoledronic acid for up to a total of 9 mos after discontinuing ADT maintained BMD No significant financial relationships to disclose.

scholarly journals Bone Loss in Men with Prostate Cancer Treated with Gonadotropin-Releasing Hormone Agonists1

2001 ◽  
Vol 86 (6) ◽  
pp. 2787-2791 ◽  
Author(s):  
S. Aubrey Stoch ◽  
Robert A. Parker ◽  
Liping Chen ◽  
Glenn Bubley ◽  
Yoo-Joung Ko ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Bone Loss ◽  
Gonadotropin Releasing Hormone ◽  
Releasing Hormone

The skeletal effects of gonadotropin-releasing hormone antagonists: a concise review

2020 ◽  
Vol 21 ◽  
Author(s):  
Nur-Vaizura Mohamad ◽  
Ima-Nirwana Soelaiman ◽  
Kok-Yong Chin
Keyword(s):  
Prostate Cancer ◽  
Bone Loss ◽  
Animal Studies ◽  
Fragility Fractures ◽  
Gonadotropin Releasing Hormone ◽  
Prolonged Treatment ◽  
Gnrh Antagonists ◽  
Releasing Hormone ◽  
Gonadotropin Releasing Hormone Antagonists ◽  
Skeletal Effects

: Prolonged treatment with gonadotropin-releasing hormone (GnRH) agonists is known to induce bone loss among prostate cancer patients. However, evidence on the skeletal effects of GnRH antagonists is relatively less well-known. This review aims to examine the effects of GnRH antagonists on bone health. GnRH antagonists are an effective treatment for hormone-dependent conditions, such as advanced prostate cancer and endometriosis. They induce a competitive and reversible GnRH-receptor blockage, thereby suppressing the release of gonadotropins and sex hormones. The sex hormone ablation results in undesirable side effects, including accelerated bone loss. In animal studies, treatment with GnRH antagonists is reported to cause deterioration of bone microstructure. Human clinical trials revealed significant bone loss at the spine, hip and femur in patients treated with GnRH antagonists. Thus, osteoporosis and the resultant fragility fractures pose a significant impact on health and quality of life of GnRH antagonist users. Thus, early preventive measures of bone loss are critical in preventing fractures and its associated morbidity in these patients.

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