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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period

The purpose of this study is to determine the effect of AZD0530 on subjects with breast cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.

Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects with Metastatic Bone Disease

Cancer Study Locator (US and Canada only)

Research Site

A Phase II, Randomised, Open-Label, Pilot Study to Evaluate the Safety and Effects on Bone Resorption of AZD0530 in Patients with Prostate Cancer or Breast Cancer with Metastatic Bone Disease.

Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.

Age Continuous

Gender, Male/Female

Non-compliant patients were excluded from the biomarker analysis, in order to accurately assess effects due to treatment.  The compliance criteria did not apply to the zoledronic acid arm, which led to an imbalance in the number of subjects analysed.

The number of participants analyzed  reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.

Percentage change from baseline in serum beta C-terminal cross-linking telopeptide of Type I collagen (betaCTX) at Week 4

The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.

Percentage change from baseline in serum bone-specific alkaline phosphatase (bALP) at Week 4

Percentage change from baseline in serum cross-linked C-terminal telopeptide of Type I collagen (ICTP) at Week 4

Percentage change from baseline in serum N-terminal propeptide of Type I procollagen (PINP) at Week 4

Percentage change from baseline in serum tartrate-resistant acid phosphatase 5b (TRAP5b) at Week 4

Percentage change from baseline in urine N-terminal cross-linking telopeptide of Type I collagen normalised to creatinine (NTx/Cr) at Week 4

Percentage change from baseline in urine alpha-alpha C-terminal cross-linking telopeptide of Type I collagen normalised to creatinine (aaCTx/Cr) at Week 4

Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.

Arms	Assigned Interventions
Experimental: AZD0530 175 mg AZD0530 (saracatinib) 175 mg once daily	Drug: AZD0530 Daily oral dose Other Name: Saracatinib
Experimental: Zoledronic Acid 4 mg Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period	-

Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects with Metastatic Bone Disease

Official Title

Medical condition

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Healthy volunteers

Study drug

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Actual Enrollment

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Age

Date

Study design

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Documents available

Cancer Study Locator (US and Canada only)

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=415&filename=CSR-D8180C00034.pdf

CSR-D8180C00034.pdf

CSR-D8180C00034.pdf

Trial Results Summaries

Contacts

Contact

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Investigators

Principal Investigator