NCT00048841

Brief Summary

The purpose of this two year study is to examine the safety and effectiveness of alendronate (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to lower their testosterone levels. All men will receive appropriate calcium and vitamin D supplements and one to two years of alendronate therapy. Bone density tests will be done every six months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started May 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2002

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

November 8, 2002

Last Update Submit

March 1, 2010

Conditions

Prostate CancerOsteoporosisHypogonadism

Keywords

MaleOsteoporosisProstate cancerHypogonadismBisphosphonatesBone mineral density

Outcome Measures

Primary Outcomes (2)

  • PA spine BMD over 1 year

  • Change in PA spine BMD over 2nd year

Secondary Outcomes (1)

  • BMD at the hip and lateral spine

Interventions

alendronateDRUG

Eligibility Criteria

Age50 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men age 50-85
  • Stage D0 prostate cancer
  • On androgen deprivation therapy

You may not qualify if:

  • Renal failure
  • Hyperthyroidism
  • Cushing's syndrome
  • Metabolic bone disease
  • Use of glucocorticoids
  • Use of certain anticonvulsants
  • On osteoporosis therapies
  • Nonprostate cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osteoporosis Prevention & Treatment Center

Pittsburgh, Pennsylvania, 15213-3221, United States

Location

Related Publications (1)

  • Greenspan SL, Nelson JB, Trump DL, Resnick NM. Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer: a randomized trial. Ann Intern Med. 2007 Mar 20;146(6):416-24. doi: 10.7326/0003-4819-146-6-200703200-00006.

    PMID: 17371886DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsOsteoporosisHypogonadism

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Susan L. Greenspan, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

November 8, 2002

First Posted

November 13, 2002

Study Start

May 1, 2002

Study Completion

December 1, 2005

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)