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

NCT00177619 | Completed Phase 3

• 1 other identifier: 5R01DK061536
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Prostatic neoplasms; Bisphosphonates; Hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Alendronate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Hypogonadism

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic 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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

US (1)