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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00859027
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : August 1, 2013
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Proctor and Gamble/Aventis
Information provided by (Responsible Party):
Pamela Taxel, UConn Health

Tracking Information
First Submitted Date  ICMJE March 7, 2009
First Posted Date  ICMJE March 10, 2009
Results First Submitted Date  ICMJE August 22, 2012
Results First Posted Date  ICMJE August 1, 2013
Last Update Posted Date May 1, 2018
Study Start Date  ICMJE January 2003
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
Percent Change in Bone Mineral Density [ Time Frame: baseline and 6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2009)
Bone mineral density [ Time Frame: 6 and 12 months ]
Change History Complete list of historical versions of study NCT00859027 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
Percent Change of Bone Turnover Markers [ Time Frame: Baseline and 6 months ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2009)
Bone Turnover Markers [ Time Frame: 6 and 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Official Title  ICMJE The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, placebo controlled trial.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: risedronate
    35 mg/week by mouth
    Other Name: Actonel
  • Drug: Placebo risedronate oral tablet
    One tablet by mouth every week as directed
Study Arms  ICMJE
  • Experimental: Risedronate
    35 mg by mouth every week as directed
    Intervention: Drug: risedronate
  • Placebo Comparator: risedronate placebo tablet
    Calcium and vitamin D
    Intervention: Drug: Placebo risedronate oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2009)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00859027
Other Study ID Numbers  ICMJE 02-062
GCRC # 413
None given ( Other Grant/Funding Number: Procotor and Gamble/Aventis )
None given ( Other Identifier: Procotor and Gamble/Aventis )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pamela Taxel, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE Proctor and Gamble/Aventis
Investigators  ICMJE
Principal Investigator: Pamela Taxel, MD UConn Health
PRS Account UConn Health
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP