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OpenTrials
Completed

NCT Number: NCT00816452

Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer

Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.

Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

Secondary objectives:

To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.

To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

60 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Sanofi-aventis administrative office

Netanya, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Man with Prostate Cancer
  • Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
  • Osteopenia/osteoporosis proven by bone density test.

Exclusion criteria

  • Creatinine clearance < 30ml/min
  • Hypercalcemia
  • Actual treatment by Bisphosphonate or steroids
  • Hypersensibility to Bisphosphonate or any contraindication to its use.
  • Metastatic prostate Cancer
  • Patients not suitable for compliance.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Primary outcomes

  1. To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

    Time frame: 6 months

Secondary outcomes

  1. To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.

    Time frame: 6 months

  2. To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics

    Time frame: 6 months

  3. To evaluate incidence of osteopenia/osteoporosis in this study population.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.

Acronym: InoPro

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 1, 2009
Registry last updated
Nov 3, 2010

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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