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Completed

NCT Number: NCT00859027

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

55 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

Drug

35 mg/week by mouth

Other names: Actonel

Placebo risedronate oral tablet

Drug

One tablet by mouth every week as directed

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Proctor and Gamble/Aventis

Registry information

Official study title

The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Mar 10, 2009
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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