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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
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Non-metastatic

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
March 7, 2009
Last Updated
April 11, 2018
Sponsor
UConn Health
Collaborators
Proctor and Gamble/Aventis
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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

Learn more about this trial

Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer

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