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Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alendronate
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostatic neoplasms, Bisphosphonates, Hypogonadism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Men age 18 and older with stage Do prostate cancer (as defined by asymptomatic disease, rising PSA, and negative bone scans) following attempted curative surgery and/or radiation Androgen deprivation therapy (gonadotropin releasing hormone agonists, lutenizing hormone releasing hormone agonists, testosterone antagonists, orchiectomy) for at least 6 months for treatment of prostate cancer Exclusion Criteria: History of any illness known to affect bone and mineral metabolism (renal failure, hepatic failure, Paget's disease, osteogenesis imperfecta, osteomalacia) Non-prostate cancer diagnosed within last 5 years (treated superficial basal and squamous cell carcinoma excepted) Hyperparathyroidism Malabsorption Treatment with medications known to affect bone metabolism (chronic high-dose corticosteroid therapy for at least 6 months, thyroid hormone with TSH <0.1 micrograms, antiseizure medications) Active peptic ulcer Inability to sit upright or stand for at least 30 minutes Kidney stones in the past 5 years 24-hour urine calcium value >400 mg/24 hours Esophageal stricture or achalasia Hyperthyroidism Evidence of chronic liver disease (including alcoholism) Treatment within past year for osteoporosis (calcitonin, fluoride, bisphosphonates) History of atraumatic fractures, previous fracture due to a fall from standing height or lesser trauma, or clinical osteoporosis Metastatic prostate cancer Inability to provide written informed consent

Sites / Locations

  • University of Pittsburgh

Outcomes

Primary Outcome Measures

Our primary outcome variable will be change in spine bone mineral density over one year and change during the second year (or both years).

Secondary Outcome Measures

Secondary endpoints will be bone mineral density at the hip and lateral spine.

Full Information

First Posted
September 13, 2005
Last Updated
February 10, 2014
Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00177619
Brief Title
Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)
Official Title
Prevention of Osteoporosis in Men With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary
The overall goal of this proposal is to determine the effectiveness and safety of once weekly alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with prostate cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following termination of therapy after one year.
Detailed Description
While osteoporosis in women is recognized as a major public health problem, osteoporosis in men also has a profound clinical impact. Men over the age of 75 who sustain hip fractures have a higher mortality than women of the same age (30% versus 9%). Hip fractures in men account for one-third of all hip fractures. In 1995, male osteoporosis accounted for $2.7 billion in health care costs -- nearly one-third of the overall cost of osteoporosis. Alendronate has been shown to improve bone mass and decrease vertebral fractures in men with osteoporosis. Prostate cancer is the most common visceral malignancy and the second leading cause of death in American men. Almost all men who progress to late stage disease are treated with androgen deprivation therapy for life, resulting in a 5-fold increased risk of hip fractures and a 13-fold increased risk of all osteoporosis fractures. Several studies suggest the merit of inducing androgen deprivation much earlier in the course of therapy for prostate cancer. It is therefore quite likely that androgen deprivation strategies will be employed with increasing frequency in patients with less advanced disease, resulting in longer life expectancy but greater bone loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatic neoplasms, Bisphosphonates, Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alendronate
Primary Outcome Measure Information:
Title
Our primary outcome variable will be change in spine bone mineral density over one year and change during the second year (or both years).
Secondary Outcome Measure Information:
Title
Secondary endpoints will be bone mineral density at the hip and lateral spine.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men age 18 and older with stage Do prostate cancer (as defined by asymptomatic disease, rising PSA, and negative bone scans) following attempted curative surgery and/or radiation Androgen deprivation therapy (gonadotropin releasing hormone agonists, lutenizing hormone releasing hormone agonists, testosterone antagonists, orchiectomy) for at least 6 months for treatment of prostate cancer Exclusion Criteria: History of any illness known to affect bone and mineral metabolism (renal failure, hepatic failure, Paget's disease, osteogenesis imperfecta, osteomalacia) Non-prostate cancer diagnosed within last 5 years (treated superficial basal and squamous cell carcinoma excepted) Hyperparathyroidism Malabsorption Treatment with medications known to affect bone metabolism (chronic high-dose corticosteroid therapy for at least 6 months, thyroid hormone with TSH <0.1 micrograms, antiseizure medications) Active peptic ulcer Inability to sit upright or stand for at least 30 minutes Kidney stones in the past 5 years 24-hour urine calcium value >400 mg/24 hours Esophageal stricture or achalasia Hyperthyroidism Evidence of chronic liver disease (including alcoholism) Treatment within past year for osteoporosis (calcitonin, fluoride, bisphosphonates) History of atraumatic fractures, previous fracture due to a fall from standing height or lesser trauma, or clinical osteoporosis Metastatic prostate cancer Inability to provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Greenspan, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)

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