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Completed

NCT Number: NCT02576652

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

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).

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helen Hayes Hospital, West Haverstraw, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetracycline

Other

Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.

Demeclocycline

Other

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

Total hip replacement

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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