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A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2

Conditions

Breast Cancer
Metastatic Bone Disease

Treatments

Drug: Odanacatib
Drug: ZA
Drug: ZA matching placebo
Drug: Odanacatib matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00399802
0822-016
MK-0822-016 (Other Identifier)
2006_533 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient has histologically or cytologically-confirmed breast cancer
  • Patient has documented skeletal metastases

Exclusion criteria

  • Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 2 patient groups

Single IV infusion of ZA 4 mg
Active Comparator group
Description:
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.
Treatment:
Drug: Odanacatib matching placebo
Drug: ZA
Odanacatib 5 mg
Experimental group
Description:
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.
Treatment:
Drug: ZA matching placebo
Drug: Odanacatib

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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