Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Tetracycline; Demeclocycline; Total Hip Replacement
Intervention description: 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.
Intervention MeSH terms: Tetracycline; Demeclocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 50 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: bone biopsy; tetracycline; demeclocycline; total hip replacement

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).
    

Eligibility 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