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

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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: risedronate Drug: Placebo risedronate oral tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo controlled trial.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men
Study Start Date : January 2003
Actual Primary Completion Date : March 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Risedronate
35 mg by mouth every week as directed
Drug: risedronate
35 mg/week by mouth
Other Name: Actonel

Placebo Comparator: risedronate placebo tablet
Calcium and vitamin D
Drug: Placebo risedronate oral tablet
One tablet by mouth every week as directed




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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): NCT00859027


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Proctor and Gamble/Aventis
Investigators
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Principal Investigator: Pamela Taxel, MD UConn Health

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Responsible Party: Pamela Taxel, Principal Investigator, UConn Health
ClinicalTrials.gov Identifier: NCT00859027     History of Changes
Other Study ID Numbers: 02-062
GCRC # 413
None given ( Other Grant/Funding Number: Procotor and Gamble/Aventis )
None given ( Other Identifier: Procotor and Gamble/Aventis )
First Posted: March 10, 2009    Key Record Dates
Results First Posted: August 1, 2013
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Pamela Taxel, UConn Health:
Non-metastatic

Additional relevant MeSH terms:
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Risedronic Acid
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents