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Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement

Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement

NCT02576652•Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).

Eligibility

Age

50 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures
•Ambulatory postmenopausal women and men with osteoporosis
•Scheduled to undergo elective THR due to osteoarthritis of the hip
•Received at least 2 doses of denosumab 60 mg subcutaneously over 18 months
•Last dose of denosumab within 6 months of scheduled THR

Exclusion Criteria

•Received treatment for osteoporosis other than denosumab in one year prior to THR
•Subjects with current diagnosis of any of the following conditions are excluded
•* Current, uncontrolled hypo- or hyperthyroidism (subjects who have controlled hypo- or hyperthyroidism may be eligible, provided that they have been on a stable therapy for at least 3 months \[per subject report\])
•* Current, hypo- or hyperparathyroidism
•* Osteomalacia
•* Paget's disease of bone
•* Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta)
•* Severe chronic kidney disease (CKD), defined as CKD stage 4 or greater
•Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
•Self-reported alcohol or drug abuse within the previous 12 months
+5 more criteria

Locations (2)

Helen Hayes Hospital

West Haverstraw, New York, United States

Research Site

West Haverstraw, New York, United States

Key Dates

Start Date

December 22, 2015

Primary Completion Date

December 18, 2017

Completion Date

December 18, 2017

Last Updated

April 26, 2019

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

Tetracycline

OTHER

Demeclocycline

OTHER

Total Hip Replacement

PROCEDURE

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

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: April 26, 2019Data 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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Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

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