Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
risedronate
Placebo risedronate oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Non-metastatic
Eligibility Criteria
Inclusion Criteria:
- Non-metastatic prostate cancer
- Men to receive Gonadotropin-releasing Hormone-agonist therapy
Exclusion Criteria:
- Other cancers except skin cancer
- Evidence of metabolic bone disease
- Prior use of bisphosphonates
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Risedronate
risedronate placebo tablet
Arm Description
35 mg by mouth every week as directed
Calcium and vitamin D
Outcomes
Primary Outcome Measures
Percent Change in Bone Mineral Density
BMD was measured by dual-energy X-ray absorptiometry (Lunar DXA-IQ, Madison, WI, USA). The BMD of the femoral neck, total hip, and lumbar spine (L1-L4) was measured. Underlying data are no longer available; reported means have been estimated from the results publication.
Secondary Outcome Measures
Percent Change of Bone Turnover Markers
Bone turnover markers including N-telopeptide (NTX), serum C-telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication.
Full Information
NCT ID
NCT00859027
First Posted
March 7, 2009
Last Updated
April 11, 2018
Sponsor
UConn Health
Collaborators
Proctor and Gamble/Aventis
1. Study Identification
Unique Protocol Identification Number
NCT00859027
Brief Title
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Official Title
The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Proctor and Gamble/Aventis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.
Detailed Description
A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone were measured at baseline and at 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Non-metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo controlled trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risedronate
Arm Type
Experimental
Arm Description
35 mg by mouth every week as directed
Arm Title
risedronate placebo tablet
Arm Type
Placebo Comparator
Arm Description
Calcium and vitamin D
Intervention Type
Drug
Intervention Name(s)
risedronate
Other Intervention Name(s)
Actonel
Intervention Description
35 mg/week by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo risedronate oral tablet
Intervention Description
One tablet by mouth every week as directed
Primary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density
Description
BMD was measured by dual-energy X-ray absorptiometry (Lunar DXA-IQ, Madison, WI, USA). The BMD of the femoral neck, total hip, and lumbar spine (L1-L4) was measured. Underlying data are no longer available; reported means have been estimated from the results publication.
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Percent Change of Bone Turnover Markers
Description
Bone turnover markers including N-telopeptide (NTX), serum C-telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-metastatic prostate cancer
Men to receive Gonadotropin-releasing Hormone-agonist therapy
Exclusion Criteria:
Other cancers except skin cancer
Evidence of metabolic bone disease
Prior use of bisphosphonates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Taxel, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
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Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
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