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Trial record 26 of 215 for:    TETRACYCLINE

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

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ClinicalTrials.gov Identifier: NCT02576652
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Osteoporosis
Interventions Other: Tetracycline
Other: Demeclocycline
Procedure: Total Hip Replacement
Enrollment 6
Recruitment Details This study was conducted at one center in the United States.
Pre-assignment Details  
Arm/Group Title Osteoarthritis Participants
Hide Arm/Group Description Participants 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 the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Period Title: Overall Study
Started 6
Completed 4
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Osteoarthritis Participants
Hide Arm/Group Description Participants 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 the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
68.7  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
6
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
White
6
 100.0%
1.Primary Outcome
Title Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
Hide Description

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.

Time Frame Days 22-58 (at the time of hip replacement surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had an evaluable biopsy for fluorochrome labeling.
Arm/Group Title Osteoarthritis Participants
Hide Arm/Group Description:
Participants 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 the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percentage of participants
100
2.Secondary Outcome
Title Modeling Based Formation Units in the Femoral Neck
Hide Description

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 number of modeling based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface.

Time Frame Days 22-58 (at the time of hip replacement surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who had an evaluable biopsy for fluorochrome labeling.
Arm/Group Title Osteoarthritis Participants
Hide Arm/Group Description:
Participants 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 the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units/mm
Cancellous Region 0.1455  (0.2097)
Endocortical Region 0.2223  (0.2306)
Periosteal Region 0.1990  (0.1409)
3.Secondary Outcome
Title Overfilled Remodeling-based Formation Units in the Femoral Neck
Hide Description

Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.

Remodeling-based formation units in active bone‐forming, tetracycline‐labeled surfaces were identified by a scalloped cement line. The number of overfilled remodeling-based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported as units per mm of bone surface.

Time Frame Days 22-58 (at the time of hip replacement surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who had an evaluable biopsy for fluorochrome labeling.
Arm/Group Title Osteoarthritis Participants
Hide Arm/Group Description:
Participants 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 the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units/mm
Cancellous Region 0.0038  (0.0062)
Endocortical Region 0.0108  (0.0138)
Periosteal Region 0.0000  (0.0000)
4.Secondary Outcome
Title Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
Hide Description

Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.

Remodeling based formation units in active bone‐forming, tetracycline‐labeled surfaces were identified by a scalloped cement line. The number of remodeling based formation units including overfilled units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface.

Time Frame Days 22-58 (at the time of hip replacement surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who had an evaluable biopsy for fluorochrome labeling.
Arm/Group Title Osteoarthritis Participants
Hide Arm/Group Description:
Participants 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 the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units/mm
Cancellous Region 0.0285  (0.0174)
Endocortical Region 0.0323  (0.0318)
Periosteal Region 0.0033  (0.0065)
Time Frame From the date of first administration of fluorochrome treatment (tetracycline or democlocycline or their derivatives) until the date of THP surgery (up to 58 days).
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Total Hip Replacement
Hide Arm/Group Description Participants previously treated with denosumab and planning to undergo 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 the receipt of the last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
All-Cause Mortality
Total Hip Replacement
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Total Hip Replacement
Affected / at Risk (%)
Total   1/6 (16.67%) 
Infections and infestations   
Arthritis infective  1  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total Hip Replacement
Affected / at Risk (%)
Total   2/6 (33.33%) 
Immune system disorders   
Hypersensitivity  1  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Urticaria  1  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02576652     History of Changes
Other Study ID Numbers: 20140259
First Submitted: May 26, 2015
First Posted: October 15, 2015
Results First Submitted: December 6, 2018
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019