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Trial record 19 of 22 for:    paget's disease of bone

Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer

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ClinicalTrials.gov Identifier: NCT02622607
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Brief Summary:
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of skeletal-related events(SREs)from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid(ZOL) in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Zoledronic acid Phase 3

Detailed Description:
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. which can lead to pain, decreased mobility and skeletal complications .Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of SREs from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer
Study Start Date : January 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: ZOL
Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 months for 12 months.
Drug: Zoledronic acid
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride)
Other Name: Zometa

No Intervention: Control
No investigational treatment



Primary Outcome Measures :
  1. Percentage of Participants With Bone Metastases at 12 Months [ Time Frame: Months 12 ]
    Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).


Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Up to 24 months ]
    Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

  2. Percentage of Participants With Overall Survival [ Time Frame: Months 6, 12, 18, and 24 ] ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 70 years of age, male or female
  2. histologically or cytologically confirmed stage IIIB or IV lung cancer at diagnosis
  3. no evidence of bone metastatic lesions was radiographically confirmed by bone scintigraphy
  4. life expectancy of ≥6 months
  5. adequate renal, hematologic, and hepatic
  6. Eastern Cooperative Oncology Group(ECOG) performance status≤2
  7. All patients provided written informed consent

Exclusion Criteria:

  1. Treatment with other bisphosphonates
  2. Presence of brain metastases
  3. Be allergic to ZOL
  4. attending other unlisted drug clinical trials,currently.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622607


Contacts
Contact: He-Long Zhang, M.D. 13519128910 zhanghelong@medmail.com.cn
Contact: Mi Jiao, M.M. 18392467550 mimi10903@126.com

Locations
China, Shaanxi
Department of Oncology,Tangdu Hospital,Fourth Millitary Medical University Recruiting
XI'an, Shaanxi, China, 710000
Contact: He-Long Zhang, M.D.    13519128910    zhanghelong@medmail.com.cn   
Contact: Mi Jiao, M.M.    18392467550    mimi10903@126.com   
Sponsors and Collaborators
Tang-Du Hospital
Investigators
Study Chair: He-Long Zhang, M.D. Department of Oncology,Tangdu Hospital

Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02622607     History of Changes
Other Study ID Numbers: ZOL
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Tang-Du Hospital:
ZOL
Prevention
lung cancer

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Bone Density Conservation Agents
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Zoledronic acid
Diphosphonates
Physiological Effects of Drugs