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A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066) | Clinical Trials | Clareo Health

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A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)

A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated With Glucocorticoids

NCT01630616•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of single doses of odanacatib in mature adolescents and young adults who are currently receiving glucocorticoid therapy. The primary hypotheses for the study are that a single dose of odanacatib is well tolerated in mature adolescents and following single dose administration of odanacatib 50 mg, there is no clinically important difference in AUC0-inf between mature adolescents and young adults.

Eligibility

Age

12 - 25 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Female participants of reproductive potential (or other female subjects at the discretion of the investigator) must have negative serum pregnancy test and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study
•Receiving glucocorticoid therapy at a dose anticipated to be stable over the course of the study period
•X-ray evidence of closed epiphyses (growth plate) at the hand
•Nonsmoker

Exclusion Criteria

•Pregnant or unwilling to undergo pregnancy test
•History of stroke, chronic seizures, or major neurological disorder
•History of malignant neoplastic disease (cancer)
•Breastfeeding
•Primary growth disorder
•Any disease affecting the stomach or proximal small intestine resulting in malabsorption
•Received treatment which might have influenced bone turnover, including anabolic steroids, testosterone, calcitonin, calcitriol, alfacalcidol, excess vitamin A or excess vitamin D, or cyclosporine or initiation of use of birth control pills (estrogen-progestin combinations or progestin only, or depo provera) or other estrogen containing medications, or thyroid hormone unless on a stable dose for at least 1 month and has a normally functioning thyroid gland
•Previous treatment with any marketed or experimental bisphosphonate within 12 months
•History of, or evidence for, any clinically relevant metabolic bone disease (other than glucocorticoid-induced bone loss) including but not limited to primary hyperparathyroidism, hypoparathyroidism, hyperthyroidism, osteomalacia, and osteogenesis imperfecta within previous 3 years
•History of hypothyroidism
+6 more criteria

Key Dates

Start Date

March 12, 2013

Primary Completion Date

July 14, 2016

Completion Date

July 14, 2016

Last Updated

August 28, 2018

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

Odanacatib

DRUG

Placebo

DRUG

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NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

NCT05913219

Parkinson DiseaseStroke+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Smart Wearable Device (gaitQ): Walk Better Project

Step-down Therapy After Long-term Osteoporosis Treatment

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