Trial Outcomes & Findings for Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement (NCT NCT02576652)
NCT ID: NCT02576652
Last Updated: 2019-04-26
Results Overview
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.
COMPLETED
PHASE4
6 participants
Days 22-58 (at the time of hip replacement surgery)
2019-04-26
Participant Flow
This study was conducted at one center in the United States.
Participant milestones
| Measure |
Osteoarthritis Participants
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.
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Osteoarthritis Participants
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.
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
Baseline characteristics by cohort
| Measure |
Osteoarthritis Participants
n=6 Participants
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.
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Age, Continuous
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68.7 years
STANDARD_DEVIATION 8.4 • n=39 Participants
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Sex: Female, Male
Female
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6 Participants
n=39 Participants
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Sex: Female, Male
Male
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0 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Race/Ethnicity, Customized
White
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6 Participants
n=39 Participants
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PRIMARY outcome
Timeframe: Days 22-58 (at the time of hip replacement surgery)Population: All enrolled participants who had an evaluable biopsy for fluorochrome labeling.
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.
Outcome measures
| Measure |
Osteoarthritis Participants
n=4 Participants
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.
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Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
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100 percentage of participants
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SECONDARY outcome
Timeframe: Days 22-58 (at the time of hip replacement surgery)Population: Enrolled participants who had an evaluable biopsy for fluorochrome labeling.
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.
Outcome measures
| Measure |
Osteoarthritis Participants
n=4 Participants
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.
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Modeling Based Formation Units in the Femoral Neck
Cancellous Region
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0.1455 units/mm
Standard Deviation 0.2097
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Modeling Based Formation Units in the Femoral Neck
Endocortical Region
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0.2223 units/mm
Standard Deviation 0.2306
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Modeling Based Formation Units in the Femoral Neck
Periosteal Region
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0.1990 units/mm
Standard Deviation 0.1409
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SECONDARY outcome
Timeframe: Days 22-58 (at the time of hip replacement surgery)Population: Enrolled participants who had an evaluable biopsy for fluorochrome labeling.
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.
Outcome measures
| Measure |
Osteoarthritis Participants
n=4 Participants
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.
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Overfilled Remodeling-based Formation Units in the Femoral Neck
Cancellous Region
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0.0038 units/mm
Standard Deviation 0.0062
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Overfilled Remodeling-based Formation Units in the Femoral Neck
Endocortical Region
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0.0108 units/mm
Standard Deviation 0.0138
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Overfilled Remodeling-based Formation Units in the Femoral Neck
Periosteal Region
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0.0000 units/mm
Standard Deviation 0.0000
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SECONDARY outcome
Timeframe: Days 22-58 (at the time of hip replacement surgery)Population: Enrolled participants who had an evaluable biopsy for fluorochrome labeling.
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.
Outcome measures
| Measure |
Osteoarthritis Participants
n=4 Participants
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.
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Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
Endocortical Region
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0.0323 units/mm
Standard Deviation 0.0318
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Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
Cancellous Region
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0.0285 units/mm
Standard Deviation 0.0174
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Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
Periosteal Region
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0.0033 units/mm
Standard Deviation 0.0065
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Adverse Events
Total Hip Replacement
Serious adverse events
| Measure |
Total Hip Replacement
n=6 participants at risk
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.
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Infections and infestations
Arthritis infective
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16.7%
1/6 • 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).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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Other adverse events
| Measure |
Total Hip Replacement
n=6 participants at risk
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.
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Immune system disorders
Hypersensitivity
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16.7%
1/6 • 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).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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Skin and subcutaneous tissue disorders
Urticaria
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16.7%
1/6 • 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).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER