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Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC (SubDueP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062503
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : April 27, 2015
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Bone is the most common site of metastases in prostate cancer and bone complications cause substantial morbidity to this population. Phase III studies have shown that zoledronic acid is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such treatment is high, and the risk of exposing patients (especially those at low risk) to potential serious side effects with uncertain benefit warrants investigation. This study will determine the duration of suppression of bone turnover in prostate cancer patients with bone metastases following a single infusion of Zoledronic Acid and its effect on quality of life.

Condition or disease Intervention/treatment
Metastatic Prostate Cancer Bone Metastasis Drug: Zoledronic acid

Detailed Description:

The bone is the most common site of metastasis in men with prostate cancer, and that bone metastases are associated with a significant risk of SREs. Prevention and delay in onset of SREs has been demonstrated with use of ZA. The optimal dosing frequency of ZA is not known in this population but it is usually given every 3-4 weeks, whereas injections as infrequently as once yearly protect from bone loss in patients without bone metastases who are receiving ADT. uNTX, sCTX and BAP are markers of bone turnover and bone formation that are suppressed in response to ZA and are associated with the likelihood of development of an SRE. In this study, we propose to determine the duration of suppression of bone turnover (all uNTX, sCTX and BAP) in response to a single dose of ZA in patients with castration resistant prostate cancer metastatic to bone.

Our objectives for this study:

  1. To estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of ZA.
  2. To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of ZA.
  3. To evaluate the frequency of SREs experienced by patients in this population.
  4. To measure quality of life and presence of bone pain over a 12 week period in this patient population by utilizing the Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP) and Brief Pain Inventory (BPI) questionnaires.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic Castration Resistant Prostate Cancer
Study Start Date : January 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Drug: Zoledronic acid
    ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
    Other Name: Zometa

Primary Outcome Measures :
  1. Patients given single dose of Zoledronic Acid 4mg IV [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Brief Pain Inventory Location Questionnaire [ Time Frame: Baseline, Q6weeks, Q12weeks, 26weeks ]
  2. FACT-BP Quality of Life Questionnaire [ Time Frame: Baseline, Q6weeks, Q12weeks, 26weeks ]
  3. We will monitor for uNTX, sCTX, BAP (fasting morning sample) [ Time Frame: Baseline, Q3wks, Q6wks, Q9wks Q12wks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a non-randomized observational study

Inclusion Criteria:

  • Patients must have histologically confirmed prostate cancer that has become castration resistant
  • Radiological or pathological evidence of bone metastases. (Positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic prostate cancer)
  • Patient has not yet started on BP therapy for metastatic castration resistant prostate cancer
  • Renal and hepatic function within the institutional normal range or at the discretion of the Investigator
  • Age ≥ 18 years
  • ECOG performance status ≤ 2
  • Life expectancy >6 months
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Hypersensitivity or known allergy to bisphosphonates
  • Patient who has received BP therapy for any reason within the past 1 year
  • Acute or chronic renal insufficiency
  • Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks)
  • Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved)
  • Patients with baseline hypocalcemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01062503

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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Ian F Tannock, MD, PhD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT01062503     History of Changes
Obsolete Identifiers: NCT01016171
Other Study ID Numbers: REB 09-0688-C
PRIT9 ( Other Grant/Funding Number: Self )
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015

Keywords provided by University Health Network, Toronto:

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs