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risedronate for Lung Cancer

Phase 2
Waitlist Available
Led By Michael Farris, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months, 6 months, 9 months and 12 months post radiation
Awards & highlights

Study Summary

This trial will compare the rate of bone loss in patients with peripheral lung tumors who are treated with SBRT with or without a single dose of 150 mg risedronate given prior to treatment.

Eligible Conditions
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months, 6 months, 9 months and 12 months post radiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months, 6 months, 9 months and 12 months post radiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Mean Cortical Thickness
Secondary outcome measures
4 Time Points Assessing Change in Mean Cortical Thickness of Bones
Number of Participants With Chest Wall Pain
Number of Participants With Rib and Vertebral Fracture
+1 more

Side effects data

From 2013 Phase 4 trial • 109 Patients • NCT00485953
49%
Musculoskeletal related events
47%
Other events
24%
Infection related events
9%
Cardiovascular related events
7%
Breast related events
7%
Other cancers
7%
Gastrointestinal related events
5%
Urogenital related events
4%
Respiratory related events
4%
Endocrine related events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Active Medicine Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RisedronateExperimental Treatment1 Intervention
Risedronate 150 mg given once 7-21 days prior to initiation of SBRT
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
risedronate
2019
Completed Phase 4
~4470

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,153 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,405 Total Patients Enrolled
Michael Farris, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
118 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any participants currently being enrolled for this research?

"This trial is no longer in search of patients. The research was first published on July 12th 2019 and last edited on September 13th 2022, so it has since been concluded. However, there are currently 1493 clinical trials for neoplasms, lung diseases, and risedronate that are still recruiting participants."

Answered by AI

Are there any preceding reports regarding the efficacy of risedronate?

"Presently, 3 clinical trials for risedronate are active with 1 in Phase 3. While Winston-Salem is a primary site, there exist 4 additional locations offering the medication trial."

Answered by AI

Has the FDA given its endorsement to risedronate?

"Considering the Phase 2 status of this trial and existing safety data, our team gave risedronate a score of two. However, there is no evidence yet to confirm its efficacy."

Answered by AI

What is the upper limit for enrollment in this clinical experiment?

"This study has concluded its patient recruitment. It was initially posted on July 12th 2019 and the last edit occured on September 13th 2022. There are several other trials looking for neoplasm, lung, or risedronate patients with 1493 and 3 active recruitments respectively."

Answered by AI

To what medical conditions is risedronate typically prescribed?

"Risedronate is a common remedy for osteoporosis, however it can also be employed to address malignant neoplasms, postmenopausal issues, and bone-related ailments."

Answered by AI
~15 spots leftby Apr 2025