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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_533 | Other Identifier | Merck Registration Number | |
| MK-0822-016 | Other Identifier | Merck Protocol Number |
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This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single IV infusion of ZA 4 mg | Active Comparator | Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. |
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| Odanacatib 5 mg | Experimental | Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZA | Drug | Single ZA 4 mg IV infusion at the start of treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4 | u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx. | Baseline and Week 4 |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to 6 weeks |
| Number of Participants Who Discontinued Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4 | u-DPD is a biochemical marker of bone resorption. Participants provided urine specimens on Day 1 (baseline) and Week 4 for measurement of u-DPD. | Baseline and Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21147688 | Result | Jensen AB, Wynne C, Ramirez G, He W, Song Y, Berd Y, Wang H, Mehta A, Lombardi A. The cathepsin K inhibitor odanacatib suppresses bone resorption in women with breast cancer and established bone metastases: results of a 4-week, double-blind, randomized, controlled trial. Clin Breast Cancer. 2010 Dec 1;10(6):452-8. doi: 10.3816/CBC.2010.n.059. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Intravenous (IV) Infusion of Zoledronic Acid (ZA) 4 mg | Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. |
| FG001 | Once-daily Odanacatib 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Odanacatib | Drug | Once-daily odanacatib 5 mg tablet for 4 weeks |
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| Odanacatib matching placebo | Drug | Once-daily odanacatib matching placebo for 4 weeks |
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| ZA matching placebo | Drug | Single IV infusion of ZA matching placebo given at the start of treatment |
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Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single IV Infusion of ZA 4 mg | Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. |
| BG001 | Once-daily Odanacatib 5 mg | Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4 | u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx. | All randomized participants who took at least one dose of study drug and had available u-NTx data for Baseline and Week 4 | Posted | Mean | 95% Confidence Interval | Percentage change | Baseline and Week 4 |
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| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | All randomized participants who took at least one dose of study drug | Posted | Count of Participants | Participants | Up to 6 weeks |
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| Primary | Number of Participants Who Discontinued Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | All randomized participants who took at least one dose of study drug | Posted | Count of Participants | Participants | Up to 4 weeks |
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| Secondary | Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4 | u-DPD is a biochemical marker of bone resorption. Participants provided urine specimens on Day 1 (baseline) and Week 4 for measurement of u-DPD. | All randomized participants who took at least one dose of study drug and had available u-DPD data for Baseline and Week 4 | Posted | Mean | 95% Confidence Interval | Percentage change | Baseline and Week 4 |
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Up to 6 weeks
All randomized participants who took at least one dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single IV Infusion of ZA 4 mg | Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. | 2 | 14 | 10 | 14 | ||
| EG001 | Once-daily Odanacatib 5 mg | Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment. | 4 | 29 | 17 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Blood calcium decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Blood sodium decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Metamyelocyte count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Monocyte count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| C527128 | odanacatib |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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