Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 214 for:    TETRACYCLINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).

Condition or disease Intervention/treatment Phase
Osteoporosis Other: Tetracycline Other: Demeclocycline Procedure: Total Hip Replacement Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement
Actual Study Start Date : December 22, 2015
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.
Other: Tetracycline
Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.

Other: Demeclocycline
Treatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days.

Procedure: Total Hip Replacement
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.




Primary Outcome Measures :
  1. Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck [ Time Frame: Days 22-58 (at the time of hip replacement surgery) ]

    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.



Secondary Outcome Measures :
  1. Modeling Based Formation Units in the Femoral Neck [ Time Frame: Days 22-58 (at the time of hip replacement surgery) ]

    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.


  2. Overfilled Remodeling-based Formation Units in the Femoral Neck [ Time Frame: Days 22-58 (at the time of hip replacement surgery) ]

    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.


  3. Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck [ Time Frame: Days 22-58 (at the time of hip replacement surgery) ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576652


Locations
Layout table for location information
United States, New York
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993
Research Site
West Haverstraw, New York, United States, 10993
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Statistical Analysis Plan  [PDF] November 6, 2015
Study Protocol  [PDF] October 3, 2016


Additional Information:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02576652     History of Changes
Other Study ID Numbers: 20140259
First Posted: October 15, 2015    Key Record Dates
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by Amgen:
bone biopsy
tetracycline
demeclocycline
total hip replacement
Additional relevant MeSH terms:
Layout table for MeSH terms
Tetracycline
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Demeclocycline
Bone Density Conservation Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action