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
1 other identifier
interventional
6
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2017
CompletedResults Posted
Study results publicly available
April 26, 2019
CompletedApril 26, 2019
April 1, 2019
2 years
May 26, 2015
December 6, 2018
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility. Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line. The percentage of participants with fluorochrome labeling present in the cancellous or periosteal, or endocortical surfaces of the femoral neck indicative of modeling-based bone formation is reported.
Days 22-58 (at the time of hip replacement surgery)
Secondary Outcomes (3)
Modeling Based Formation Units in the Femoral Neck
Days 22-58 (at the time of hip replacement surgery)
Overfilled Remodeling-based Formation Units in the Femoral Neck
Days 22-58 (at the time of hip replacement surgery)
Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
Days 22-58 (at the time of hip replacement surgery)
Study Arms (1)
Osteoarthritis Participants
OTHERParticipants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Interventions
Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.
Treatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days.
Participants entering this study were prescheduled to undergo elective THR due to osteoarthritis. Surgery was to be performed according to local standard of care. During THR a fragment of femoral bone was acquired for histomorphometry evaluation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
- Other investigational procedures while participating in this study are excluded
- Subject has known sensitivity to any of the products to be administered (eg, tetracycline, demeclocycline) during study
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (2)
Helen Hayes Hospital
West Haverstraw, New York, 10993, United States
Research Site
West Haverstraw, New York, 10993, United States
Related Publications (1)
Dempster DW, Chines A, Bostrom MP, Nieves JW, Zhou H, Chen L, Pannacciulli N, Wagman RB, Cosman F. Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab. J Bone Miner Res. 2020 Jul;35(7):1282-1288. doi: 10.1002/jbmr.4006. Epub 2020 Apr 2.
PMID: 32163613DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2015
First Posted
October 15, 2015
Study Start
December 22, 2015
Primary Completion
December 18, 2017
Study Completion
December 18, 2017
Last Updated
April 26, 2019
Results First Posted
April 26, 2019
Record last verified: 2019-04