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Clinical Trials/EUCTR2008-004578-42-EE
EUCTR2008-004578-42-EEActive, not recruitingNot Applicable

An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - The Imaging Sub-study for the Fracture Trial

Merck & Co., Inc.0 sites350 target enrollmentStarted: October 27, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
350
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •1. Participant is already enrolled in Protocol 018.
  • •2. Participant is willing to undergo all imaging procedures and bone biopsies.
  • •3. Participant has two hips that are evaluable by DXA and QCT (e.g., contain no hardware from orthopedic procedures).
  • •4. Participant has a spinal anatomy suitable for DXA and QCT of the lumbar spine. Significant scoliosis, bone deformity, and sequelae of orthopedic procedures that result in unsuitable anatomy must be absent from the lumbar spine. At least two vertebrae from L1-L4 must be evaluable.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Participant has a history of tremors, Parkinson's disease, multiple sclerosis or other diseases that cause persistent tremors.
  • •2. Participant is unable to take a bone-labeling agent (e.g., demeclocycline or tetracycline).
  • •3. Participant has a past medical history of clotting or bleeding disorders.
  • •4. Participant is unlikely to adhere to the study procedures or keep appointments, or is planning to relocate during the study.

Investigators

Similar Trials

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Phase 1
An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - The Imaging Sub-study for the Fracture TrialMedDRA version: 9.1Level: LLTClassification code 10017082Term: Fracture due to osteoporosisMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausalPostmenopausal Osteoporosis
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